GETLEAN: Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically

• Sponsor: Dayton Interventional Radiology (Other)
• Overall Status: Completed
• CT.gov ID: NCT02248688
• Collaborator: Ohio State University (Other)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 62
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this pilot study is to achieve the collection of safety and efficacy data in patients undergoing left gastric artery embolization for morbid obesity in the United States. As secondary goal, the pilot study seeks to obtain quality of life data. This pilot study is not designed to achieve new indications for this device.

Condition or Disease	Intervention/Treatment	Phase
Arterial Embolization; Other Surgical Procedures; Obesity	Device: BeadBlock 300 - 500 Micron; Procedure: Left Gastric Artery Embolization	N/A

Detailed Description

Beadblock will be used intraarterially to occlude in this case the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone ghrelin (one of the hormones responsible for appetite) is produced. Ghrelin is a 28 amino acid hunger stimulating peptide and hormone that is produced mainly by P/D1 cells lining the fundus of the stomach and epsilon cells of the pancreas. Ghrelin has emerged as the first identified circulating hunger hormone. Ghrelin is also the only known circulating orexigen, or appetite enhancing hormone.

Left gastric artery embolization may be a minimally invasive alternative to the current surgical treatment of gastric bypass or reduction surgery. These treatments have known serious complications including anastomotic leaks, bowel obstruction, paralytic ileus, deep vein thrombosis, pulmonary embolism, gastrointestinal bleeding, dumping syndrome, and anesthesia risks resulting in morbidity and mortality.

Literature review for gastric artery embolization

Transarterial embolization is a common interventional procedure used to treat a variety of medical conditions. In the image-guided procedure, an embolic, or obstructive, agent is inserted through a catheter and placed inside an artery to prevent blood flow in an artery or to a specific area of the body. Types of embolic agents include beads, coils, gel foam,as well as other materials and devices.

Gastric artery embolization has been used since the 1970's to treat life threatening gastric hemorrhage. This is commonly accepted as standard of care and has been life saving for thousands of patients. It is even deemed to be effective enough to be used empirically in the setting of angiographically negative life threatening hemorrhage (as a reflection of its safety margin).

Recent animal studies over the past several years in porcine and canine models have shown that gastric artery embolization results in the suppression of ghrelin levels and weight loss.

Arepally, et al. (2008) first described the technique of gastric artery embolization to reduce weight gain. In a controlled study, he used sodium morrhuate within a porcine model with resultant lower ghrelin levels and significantly blunted weight gain (in otherwise rapidly growing young swine).

Paxton, et al. (SIR abstract in 2012, later published in 2013 and 2014) described the technique of 40 micron microsphere particle embolization in a similar porcine model that also resulted in lowered ghrelin levels and reduced weight gain. Also noted there was no duodenal upregulation for ghrelin.

Bawudun et al. (2012) described a technique of left gastric embolization using mixture of bleomycin and lipiodol versus polyvinyl alcohol 500-700 micron particles to create weight loss in a canine model without gastric ulceration. In addition, he demonstrated significant reduction in subcutaneous fat and plasma ghrelin.

Kipshidze, et al. (2013) performed the first in man study reported at the annual meeting of the American College of Cardiology that showed an average of 45lbs of weight loss in 6 months and reduced ghrelin levels in 5 patients with no complications (with endoscopic follow-up) in this small series using BeadBlock 300-500 micron particles. According to personal correspondence with the author of this study the weight loss is sustained for at least 1 year with no complications in these 5 patients. He also noted that an additional 7 patients have been treated without complications.

A recent retrospective case control study presented at the 2013 Radiological Society of North American annual meeting found that there was an average of 7.9% decrease in body weight (at 3 months) in 15 patients who underwent left gastric artery embolization for life threatening hemorrhage compared to 1.2% (P=0.001) for age matched controls (who underwent embolization other than the left gastric artery for upper gastrointestinal bleeding).

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically (GET LEAN)
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Embolic Agent - BeadBlock Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.	Device: BeadBlock 300 - 500 Micron; Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.; Other Names: GET LEAN ; Procedure: Left Gastric Artery Embolization

Outcome Measures

Primary Outcome Measures

1. Body Weight Average 6 Months Post-Procedure [6-Month]

   The mean body weight of all 5 participants at 6-Months post-procedure.

2. Body Weight Average 12 Months Post-Procedure [12-Month]

   The mean body weight of all 5 participants at 12-Months post-procedure.

3. Change in Average Body Weight From Baseline at 6 Months Post-Procedure [Baseline, 6 Months]

   Average change in body weight lost. Calculated as the average of participants: (6-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)

4. Change in Average Body Weight From Baseline at 12 Months Post-Procedure [Baseline, 12 Months]

   Average change in body weight lost. Calculated as the average of participants: (12-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)

5. Percentage of Excess Body Weight Loss at 6 Months Post-Procedure [Baseline, 6 Month]

   Calculated as the average of participants: (((Baseline Weight in lbs.) - (6 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))

6. Percentage of Excess Body Weight Loss at 12 Months Post-Procedure [Baseline, 12 Month]

   Calculated as the average of participants: (((Baseline Weight in lbs.) - (12 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))

7. Average Ghrelin Hormone Levels at 6 Months Post-Procedure [6-Month]

   The mean of participant's 6-Month post-procedure Ghrelin levels.

8. Average Ghrelin Hormone Levels at 12 Months Post-Procedure [12-Month]

   The mean of participant's 12-Month post-procedure Ghrelin levels.

9. Percentage Change in Ghrelin Hormone Levels From Baseline at 6 Months Post-Procedure [6-Month, Baseline]

   Calculated as the average of participants: (((6-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) * 100

10. Percentage Change in Ghrelin Hormone Levels From Baseline at 12 Months Post-Procedure [12-Month, Baseline]

    Calculated as the average of participants: (((12-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) * 100

Secondary Outcome Measures

1. Average Leptin Hormone Levels at 6 Months Post-Procedure [6-Month]

   The mean of participant's 6-month post-procedure Leptin levels.

2. Average Leptin Hormone Levels at 12 Months Post-Procedure [12-Month]

   The mean of participant's 12-month post-procedure Leptin levels.

3. Percentage Change in Leptin Hormone Levels From Baseline at 6 Months Post-Procedure [6-Month, Baseline]

   Calculated as the average of participants: (((6-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) * 100

4. Percentage Change in Leptin Hormone Levels From Baseline at 12 Months Post-Procedure [12-Month, Baseline]

   Calculated as the average of participants: (((12-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) * 100

5. Average Cholecystokinin (CCK) Hormone Levels at 6 Months Post-Procedure [6-Month]

   The mean of participant's 6-month post-procedure CCK levels.

6. Average Cholecystokinin (CCK) Hormone Levels at 12 Months Post-Procedure [12-Month]

   The mean of participant's 12-month post-procedure CCK levels.

7. Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 6 Months Post-Procedure [6-Month, Baseline]

   Calculated as the average of participants: (((6-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) * 100

8. Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 12 Months Post-Procedure [12-Month, Baseline]

   Calculated as the average of participants: (((12-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) * 100

9. Quality of Life (QOL): Averaged Short Form (SF)-36 Version 2 Physical Component Summary (PCS) at 6 Months Post-Procedure [6 Month]

   The mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50.

10. Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 6 Months Post-Procedure [6 Month, Baseline]

    The mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants: (6-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS)

11. QOL: Averaged SF-36v2 PCS at 12 Months Post-Procedure [12 Month]

    The mean of participant's 12-month post-procedure Short Form-36 Version 2 Physical Component Scores, ranging from 0-100; higher scores indicate better health status.

12. Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 12 Months Post-Procedure [12 Month, Baseline]

    The mean of participant's SF-36 Version 2 PCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants: (12-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS)

13. QOL: Averaged SF-36v2 MCS at 6 Months Post-Procedure [6 Month]

    The mean of participant's SF-36 Version 2 MCS at 6-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.

14. Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 6 Months Post-Procedure [6 Month, Baseline]

    The mean of participant's SF-36 Version 2 MCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants: (6-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS)

15. QOL: Averaged SF-36v2 MCS at 12 Months Post-Procedure [12 Month]

    The mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.

16. Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 12 Months Post-Procedure [12 Month, Baseline]

    The mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants: (12-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS)

17. 6-Month Post-Procedure Hemoglobin-A1c (HgA1c) Levels [6-Month]

    HgA1c Levels of diabetic patient 6-Months post-procedure.

18. 12-Month Post-Procedure HgA1c Levels [12-Month]

    HgA1c Levels of diabetic patient 12-Months post-procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Morbid obesity with a BMI ≥ 40 Age ≥ 22years Ability to lay supine on an angiographic table <400lbs due to table weight limits Appropriate anesthesia risk as determined by certified anesthesia provider evaluation preprocedure.

Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and also participate in the informed consent).

Subjects who have failed previous attempts at weight loss through diet, exercise, and behavior modification (as it is recommended that conservative options, such as supervised low calorie diets combined with behavior therapy and exercise, should be attempted prior to enrolling in this study).

Exclusion Criteria:

Less than 22 years of age Major surgery within the past eight weeks Previous gastric, pancreatic, hepatic and splenic surgery Previous radiation therapy to the left or right upper quadrant Previous gastric, hepatic, or splenic embolization Any history of portal venous hypertension Serum creatinine > 1.8 mg/dL History of kidney problems Pregnant or intend to become pregnant within one year History of severe bleeding disorder (platelet count less than 40,000) Allergy to materials in the embolic agents (acrylamido polyvinyl alcohol macromer) Enrolled in another study Any patient who has a history of allergic reaction to iodinated contrast Abnormal baseline gastric emptying study Patients taking anti-coagulants or antiplatelet drugs Patients currently taking or requiring chronic use of NSAID or steroid medications Patients with any chronic upper gastrointestinal complaints such as pain, nausea or vomiting Patients with any history of peptic ulcer disease Patients with any indication of gastrointestinal bleeding as documented by positive stool guaiac and complete blood count with abnormalities.

Patients with any contraindications for monitored anesthesia care or general surgery Patients with secondary causes of obesity such as Cushing's disease and hypothyroidism Patients with active substance abuse or alcoholism Patients with defined noncompliance with previous medical care Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.

Subjects with mesenteric atherosclerotic disease or abdominal angina should be excluded due to safety concerns.

Patients with hiatal hernia Patients with known aortic disease, such as dissection or aneurysm Patients with comorbidity such as cancer, peripheral arterial disease or other cardiovascular disease Patients with any abnormality on their baseline EGD Patients with a CT Angiogram demonstrate an anatomical variant in left gastric artery anatomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dayton Interventional Radiology	Dayton	Ohio	United States	45409

Sponsors and Collaborators

• Dayton Interventional Radiology
• Ohio State University

Investigators

• Principal Investigator: Mubin I Syed, MD, Dayton Interventional Radiology
• Study Director: Azim Shaikh, MD, MBA, Dayton Interventional Radiology
• Study Director: Sumeet Patel, Dayton Interventional Radiology
• Study Director: Feras J Deek, BS, BA, Dayton Interventional Radiology

Study Documents (Full-Text)

• Study Protocol - Sep 29, 2014
• Statistical Analysis Plan - Dec 28, 2021
• Informed Consent Form - Sep 29, 2014

More Information

Publications

• Arepally A, Barnett BP, Patel TH, Howland V, Boston RC, Kraitchman DL, Malayeri AA. Catheter-directed gastric artery chemical embolization suppresses systemic ghrelin levels in porcine model. Radiology. 2008 Oct;249(1):127-33. doi: 10.1148/radiol.2491071232. Erratum in: Radiology. 2008 Dec;249(3):1083. Patel, Tarek T [corrected to Patel, Tarak H].
• Bawudun D, Xing Y, Liu WY, Huang YJ, Ren WX, Ma M, Xu XD, Teng GJ. Ghrelin suppression and fat loss after left gastric artery embolization in canine model. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1460-6. doi: 10.1007/s00270-012-0362-8. Epub 2012 Feb 25.
• Bookstein JJ, Chlosta EM, Foley D, Walter JF. Transcatheter hemostasis of gastrointestinal bleeding using modified autogenous clot. Radiology. 1974 Nov;113(2):277-85.
• Bradley EL 3rd, Goldman ML. Gastric infarction after therapeutic embolization. Surgery. 1976 Apr;79(4):421-4.
• Brown KT, Friedman WN, Marks RA, Saddekni S. Gastric and hepatic infarction following embolization of the left gastric artery: case report. Radiology. 1989 Sep;172(3):731-2.
• Castañeda-Zuñiga WR, Jauregui H, Rysavy J, Amplatz K. Selective transcatheter embolization of the upper gastrointestinal tract: an experimental study. Radiology. 1978 Apr;127(1):81-3.
• Miller DL, Balter S, Cole PE, Lu HT, Schueler BA, Geisinger M, Berenstein A, Albert R, Georgia JD, Noonan PT, Cardella JF, St George J, Russell EJ, Malisch TW, Vogelzang RL, Miller GL 3rd, Anderson J; RAD-IR study. Radiation doses in interventional radiology procedures: the RAD-IR study: part I: overall measures of dose. J Vasc Interv Radiol. 2003 Jun;14(6):711-27.
• Morris DC, Nichols DM, Connell DG, Burhenne HJ. Embolization of the left gastric artery in the absence of angiographic extravasation. Cardiovasc Intervent Radiol. 1986;9(4):195-8.
• Paxton BE, Alley CL, Crow JH, Burchette J, Weiss CR, Kraitchman DL, Arepally A, Kim CY. Histopathologic and immunohistochemical sequelae of bariatric embolization in a porcine model. J Vasc Interv Radiol. 2014 Mar;25(3):455-61. doi: 10.1016/j.jvir.2013.09.016. Epub 2014 Jan 21.
• Paxton BE, Kim CY, Alley CL, Crow JH, Balmadrid B, Keith CG, Kankotia RJ, Stinnett S, Arepally A. Bariatric embolization for suppression of the hunger hormone ghrelin in a porcine model. Radiology. 2013 Feb;266(2):471-9. doi: 10.1148/radiol.12120242. Epub 2012 Nov 30.
• Prochaska JM, Flye MW, Johnsrude IS. Left gastric artery embolization for control of gastric bleeding: a complication. Radiology. 1973 Jun;107(3):521-2.
• Robbins SM, Tuten TU, Clements JL, Fekete P. Angiographic diagnosis of gastric volvulus with report of a complication following left gastric artery embolization. Gastrointest Radiol. 1988;13(2):112-4.
• Rösch J, Dotter CT, Brown MJ. Selective arterial embolization. A new method for control of acute gastrointestinal bleeding. Radiology. 1972 Feb;102(2):303-6.
• Syed MI, Morar K, Shaikh A, Craig P, Khan O, Patel S, Khabiri H. Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data. J Vasc Interv Radiol. 2016 Oct;27(10):1502-8. doi: 10.1016/j.jvir.2016.07.010. Epub 2016 Aug 24.

• Responsible Party: Dayton Interventional Radiology
• ClinicalTrials.gov Identifier: NCT02248688
• Other Study ID Numbers: Q131650
• First Posted: Sep 25, 2014
• Last Update Posted: Jan 25, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Dayton Interventional Radiology: Bariatric Embolization; Gastric Artery Emboliziation; Left Gastric Artery Embolization; Morbid Obesity; Obesity; Weight Loss; Ghrelin; Embolization
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	BeadBlock 300 - 500 Micron Will be Used as the Embolic Agent to Embolize Left Gastric Artery.
Arm/Group Description	Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 80%
Male	1 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	5 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	5 100%
Weight (Pounds) [Mean (Full Range) ]
Mean (Full Range) [Pounds]	242.2
BMI (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	42.42
Cholecystokinin (pg/mL) [Mean (Full Range) ]
Mean (Full Range) [pg/mL]	55.8
Ghrelin (pg/mL) [Mean (Full Range) ]
Mean (Full Range) [pg/mL]	794
Leptin (ng/mL) [Mean (Full Range) ]
Mean (Full Range) [ng/mL]	30.0
Hemoglobin-A1c (HgA1c) (Percentage of HgA1c) [Number]
Number [Percentage of HgA1c]	7.4
Urine Pregnancy Test (only if female of child-bearing potential) (Number of Participants) [Number]
Number [Number of Participants]	0 0%
Complete blood count (CBC) (Count of Participants)
Normal	5 100%
Abnormal	0 0%
Blood Urea Nitrogen (BUN)/Creatinine (Count of Participants)
Normal	5 100%
Abnormal	0 0%
Prothrombin Time/Partial Thromboplastin Time (PT/PTT) (Count of Participants)
Normal	5 100%
Abnormal	0 0%
Computed Tomography (CT) Angiogram (Count of Participants)
Normal	4 80%
Abnormal	1 20%
Upper Endoscopy (Count of Participants)
Normal	5 100%
Abnormal	0 0%
Stool Guaiac (Count of Participants)
Normal	5 100%
Abnormal	0 0%
Nuclear Medicine: Gastric Emptying Study (Count of Participants)
Normal	5 100%
Abnormal	0 0%
Short Form (SF)-36v2 Questionnaire, Physical Component Summary (PCS) (Scores on a Scale) [Mean (Full Range) ]
Mean (Full Range) [Scores on a Scale]	49.8
Short Form (SF)-36 Version 2 Questionnaire Mental Component Summary (MCS) (Scores on a Scale) [Mean (Full Range) ]
Mean (Full Range) [Scores on a Scale]	48.2

Outcome Measures

1. Primary Outcome

Title	Body Weight Average 6 Months Post-Procedure
Description	The mean body weight of all 5 participants at 6-Months post-procedure.
Time Frame	6-Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [lbs.]	237.6

2. Primary Outcome

Title	Body Weight Average 12 Months Post-Procedure
Description	The mean body weight of all 5 participants at 12-Months post-procedure.
Time Frame	12-Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [lbs.]	238

3. Primary Outcome

Title	Change in Average Body Weight From Baseline at 6 Months Post-Procedure
Description	Average change in body weight lost. Calculated as the average of participants: (6-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)
Time Frame	Baseline, 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [lbs]	16.6

4. Primary Outcome

Title	Change in Average Body Weight From Baseline at 12 Months Post-Procedure
Description	Average change in body weight lost. Calculated as the average of participants: (12-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)
Time Frame	Baseline, 12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [lbs]	-16.2

5. Primary Outcome

Title	Percentage of Excess Body Weight Loss at 6 Months Post-Procedure
Description	Calculated as the average of participants: (((Baseline Weight in lbs.) - (6 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))
Time Frame	Baseline, 6 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Percentage of Excess Body Weight Loss]	14.8

6. Primary Outcome

Title	Percentage of Excess Body Weight Loss at 12 Months Post-Procedure
Description	Calculated as the average of participants: (((Baseline Weight in lbs.) - (12 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))
Time Frame	Baseline, 12 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Percentage of Excess Body Weight Loss]	15.1

7. Primary Outcome

Title	Average Ghrelin Hormone Levels at 6 Months Post-Procedure
Description	The mean of participant's 6-Month post-procedure Ghrelin levels.
Time Frame	6-Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [pg/mL]	605.4

8. Primary Outcome

Title	Average Ghrelin Hormone Levels at 12 Months Post-Procedure
Description	The mean of participant's 12-Month post-procedure Ghrelin levels.
Time Frame	12-Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [pg/mL]	21.1

9. Primary Outcome

Title	Percentage Change in Ghrelin Hormone Levels From Baseline at 6 Months Post-Procedure
Description	Calculated as the average of participants: (((6-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) * 100
Time Frame	6-Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Percentage of Change in Ghrelin]	-9.9

10. Primary Outcome

Title	Percentage Change in Ghrelin Hormone Levels From Baseline at 12 Months Post-Procedure
Description	Calculated as the average of participants: (((12-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) * 100
Time Frame	12-Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Percentage of Change in Ghrelin]	-19.2

11. Secondary Outcome

Title	Average Leptin Hormone Levels at 6 Months Post-Procedure
Description	The mean of participant's 6-month post-procedure Leptin levels.
Time Frame	6-Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [ng/mL]	19.4

12. Secondary Outcome

Title	Average Leptin Hormone Levels at 12 Months Post-Procedure
Description	The mean of participant's 12-month post-procedure Leptin levels.
Time Frame	12-Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [ng/mL]	21.1

13. Secondary Outcome

Title	Percentage Change in Leptin Hormone Levels From Baseline at 6 Months Post-Procedure
Description	Calculated as the average of participants: (((6-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) * 100
Time Frame	6-Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Percentage of Change in Leptin]	-31.2

14. Secondary Outcome

Title	Percentage Change in Leptin Hormone Levels From Baseline at 12 Months Post-Procedure
Description	Calculated as the average of participants: (((12-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) * 100
Time Frame	12-Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Percentage of Change in Leptin]	21.1

15. Secondary Outcome

Title	Average Cholecystokinin (CCK) Hormone Levels at 6 Months Post-Procedure
Description	The mean of participant's 6-month post-procedure CCK levels.
Time Frame	6-Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [pg/mL]	32.4

16. Secondary Outcome

Title	Average Cholecystokinin (CCK) Hormone Levels at 12 Months Post-Procedure
Description	The mean of participant's 12-month post-procedure CCK levels.
Time Frame	12-Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [pg/mL]	44.6

17. Secondary Outcome

Title	Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 6 Months Post-Procedure
Description	Calculated as the average of participants: (((6-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) * 100
Time Frame	6-Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Percentage of Change in CCK]	-15.1

18. Secondary Outcome

Title	Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 12 Months Post-Procedure
Description	Calculated as the average of participants: (((12-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) * 100
Time Frame	12-Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Percentage of Change in CCK]	56.4

19. Secondary Outcome

Title	Quality of Life (QOL): Averaged Short Form (SF)-36 Version 2 Physical Component Summary (PCS) at 6 Months Post-Procedure
Description	The mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50.
Time Frame	6 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Scores on a Scale]	59.5

20. Secondary Outcome

Title	Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 6 Months Post-Procedure
Description	The mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants: (6-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS)
Time Frame	6 Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Scores on a Scale]	9.7

21. Secondary Outcome

Title	QOL: Averaged SF-36v2 PCS at 12 Months Post-Procedure
Description	The mean of participant's 12-month post-procedure Short Form-36 Version 2 Physical Component Scores, ranging from 0-100; higher scores indicate better health status.
Time Frame	12 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Scores on a Scale]	65.79

22. Secondary Outcome

Title	Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 12 Months Post-Procedure
Description	The mean of participant's SF-36 Version 2 PCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants: (12-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS)
Time Frame	12 Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Scores on a Scale]	16.0

23. Secondary Outcome

Title	QOL: Averaged SF-36v2 MCS at 6 Months Post-Procedure
Description	The mean of participant's SF-36 Version 2 MCS at 6-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.
Time Frame	6 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Scores on a Scale]	57

24. Secondary Outcome

Title	Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 6 Months Post-Procedure
Description	The mean of participant's SF-36 Version 2 MCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants: (6-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS)
Time Frame	6 Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Scores on a Scale]	8.9

25. Secondary Outcome

Title	QOL: Averaged SF-36v2 MCS at 12 Months Post-Procedure
Description	The mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.
Time Frame	12 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Scores on a Scale]	63.1

26. Secondary Outcome

Title	Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 12 Months Post-Procedure
Description	The mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants: (12-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS)
Time Frame	12 Month, Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	5
Mean (Full Range) [Scores on a Scale]	14.9

27. Secondary Outcome

Title	6-Month Post-Procedure Hemoglobin-A1c (HgA1c) Levels
Description	HgA1c Levels of diabetic patient 6-Months post-procedure.
Time Frame	6-Month

Outcome Measure Data

Analysis Population Description

Applies to the sole diabetic patient in the trial.

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	1
Number [Percentage of HgA1c]	6.3

28. Secondary Outcome

Title	12-Month Post-Procedure HgA1c Levels
Description	HgA1c Levels of diabetic patient 12-Months post-procedure.
Time Frame	12-Month

Outcome Measure Data

Analysis Population Description

Applies to the sole diabetic patient in the trial.

Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
Measure Participants	1
Number [Percentage of HgA1c]	5.9

Adverse Events

Time Frame	12 Months
Arm/Group Title	Embolic Agent - BeadBlock
Arm/Group Description	Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery. BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced. Left Gastric Artery Embolization
All Cause Mortality
	Embolic Agent - BeadBlock
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	Embolic Agent - BeadBlock
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Embolic Agent - BeadBlock
	Affected / at Risk (%)	# Events
Total	3/5 (60%)
Gastrointestinal disorders
Mild Nausea, Vomiting	2/5 (40%)	2
Mild Nausea, Vomiting	1/5 (20%)	1

Limitations/Caveats

Limitations included: Relatively Small Sample Size Surgical Placebo Effect Lack of Maintaining Diet and Caloric Intake Records Diet Modification and Nutritional Supervision that could account for weight loss

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.