PROMISE: Endoscopic Suturing for Primary Obesity Treatment

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01662024
• Collaborator: Apollo Endosurgery, Inc. (Industry)
• Enrollment: 20
• Locations: 4
• Arm: 1
• Duration (Months): 37.9
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Body Weight; Overweight	Device: Endoscopic gastric restrictive procedure	N/A

Detailed Description

The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.

The primary endpoint of this study is evaluation of safety and feasibility of the procedure. All subjects for whom the plication procedure is initiated (defined as placement of the overtube) will be included in the safety analysis. The primary safety analysis will assess the occurrence of adverse events through 12 months after the plication procedure.

Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic intervention. Safety will be determined as no adverse events directly related to the procedure at 12 months.

Secondary Endpoints:

1. Efficacy: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline:

• Percent excess weight loss (%EWL)

• Total weight lost (kg) and percent weight lost

• Change in (BMI) and percent change in BMI

• Change in waist circumference

• Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values

• Changes in quality of life measures as reported on Quality of Life questionnaire(s) (evaluated relative to baseline)

• Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to baseline)

1. Durability: Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Open label
• Primary Purpose: Treatment
• Official Title: Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endoscopic gastric restrictive procedure Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.	Device: Endoscopic gastric restrictive procedure; Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures; Other Names: Apollo Overstitch Endoscopic Suturing System

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [12 months]

   Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.

2. Evaluation of Technical Feasibility of the Procedure [Day 0 - Procedure Day]

   Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.

Secondary Outcome Measures

1. Percent Excess Weight Loss [12 Months]

   Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss

2. Durability [12 months]

   Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.

3. Percentage of Total Body Weight Loss [12 Months]

   Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss

4. BMI Loss (kg/m^2) [12 Months]

   Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)

5. Waist Circumference Loss (cm) [12 Months]

   Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject has met diabetic lab testing and all pre-procedural qualifications

• Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age

• Subject has a BMI of > 30 and < 35

• Subject has history of obesity for > 2 yrs

• Subject has had no significant weight change (<5% of total body weight)in last 6 months

• Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline

• Subject is a reasonable candidate for general anesthesia

• Subject agrees not to have any additional weight loss surgery or reconstructive surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc) during the trial

• Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.

• Subject must be able to fully understand and be willing to sign the informed consent

Exclusion Criteria:

• Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure

• Mallampati (intubation) score greater than 3

• Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed

• Subject has history or present use of insulin or insulin derivatives for treatment of diabetes

• Subject has diabetes secondary to a specific disease

• Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years

• Subject has history of inflammatory disease of GI tract

• Subject has a history of intestinal strictures or adhesions

• Subject has renal and/or hepatic insufficiency

• Subject has chronic pancreatic disease

• Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease and/or active peptic ulcer

• Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility

• Subject has a history of any significant abdominal surgery

• Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis

• Subject has a hiatal hernia > 2cm

• Subject has chronic/acute upper GI bleeding conditions

• Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation

• Female subject is of childbearing age and not practicing effective birth control, is pregnant or is lactating

• Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.

• Subject has cancer or life expectancy of < 2 yrs

• Subject has systemic infection in the body at the time of the plication procedure.

• Subject currently uses or has used over the counter or prescription weight loss medications in last 30 days or intends to use during follow-up Study period.

• Subjects who have started medications within the last 3 months that are known to cause weight gain

• Subjects undergoing chronic steroid therapy

• Subjects undergoing immunosuppressive therapy

• Subject has a history of drug or alcohol abuse

• Subject has a history of uncontrolled or poorly controlled psychiatric disease or suspected eating disorders

• Subject is non-ambulatory or has significant impairment of mobility

• Subject has known hormonal or genetic cause for obesity

• Subject is not in sufficient and stable medical health, as determined and evaluated by the Principal Investigator.

• Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jackson Health System	Miami	Florida	United States	33176
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
3	St. Joseph's Regional Medical Center at New Jersey	Paterson	New Jersey	United States	07503
4	University of Texas at Houston	Bellaire	Texas	United States	77401

Sponsors and Collaborators

• Brigham and Women's Hospital
• Apollo Endosurgery, Inc.

Investigators

• Principal Investigator: Christopher C. Thompson, MD, MS, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Dindo D, Muller MK, Weber M, Clavien PA. Obesity in general elective surgery. Lancet. 2003 Jun 14;361(9374):2032-5.
• Flum DR, Dellinger EP. Impact of gastric bypass operation on survival: a population-based analysis. J Am Coll Surg. 2004 Oct;199(4):543-51.
• Jirapinyo P, Watson RR, Thompson CC. Use of a novel endoscopic suturing device to treat recalcitrant marginal ulceration (with video). Gastrointest Endosc. 2012 Aug;76(2):435-9. doi: 10.1016/j.gie.2012.03.681. Epub 2012 May 31.
• Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55.
• Sjöström L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjöström CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93.
• Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc. 2002 Feb;16(2):230-3. Epub 2001 Oct 5.
• Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. Review.

• Responsible Party: Christopher Thompson, Director of Therapeutic Endoscopy, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01662024
• Other Study ID Numbers: 2012P-000799
• First Posted: Aug 10, 2012
• Last Update Posted: Mar 30, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Christopher Thompson, Director of Therapeutic Endoscopy, Brigham and Women's Hospital: Obesity; BMI; Weight loss; Gastric restriction; Bariatrics
• Additional relevant MeSH terms: Obesity; Overweight; Body Weight

Study Results

Participant Flow

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.
Period Title: Overall Study
STARTED	20
COMPLETED	15
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
Overall Participants	20
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	36.7
Sex: Female, Male (Count of Participants)
Female	20 100%
Male	0 0%
Initial Weight (kg) (kg) [Mean (Full Range) ]
Mean (Full Range) [kg]	90.4
Initial BMI (kg/m^2) (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	33.4

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.
Measure Participants	20
Peri-operative Adverse Events	5 25%
Post-operative Adverse Events	2 10%
Delayed Adverse Events	0 0%
No Adverse Events	13 65%

2. Primary Outcome

Title	Evaluation of Technical Feasibility of the Procedure
Description	Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.
Time Frame	Day 0 - Procedure Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. D
Measure Participants	20
Running Sutures	10.4
Total Stitches	54.4
Interrupted Sutures	4

3. Secondary Outcome

Title	Percent Excess Weight Loss
Description	Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.
Measure Participants	15
Mean (Full Range) [Percentage of excess weight lost]	70.8

4. Secondary Outcome

Title	Durability
Description	Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Endoscopies were performed at 12 months but it was difficult to count the number of plications still intact as originally planned.

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
Measure Participants	0
	0

5. Secondary Outcome

Title	Percentage of Total Body Weight Loss
Description	Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.
Measure Participants	15
Mean (Full Range) [Percentage of total weight lost]	18.1

6. Secondary Outcome

Title	BMI Loss (kg/m^2)
Description	Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.
Measure Participants	15
Mean (Full Range) [kg/m^2]	6.1

7. Secondary Outcome

Title	Waist Circumference Loss (cm)
Description	Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.
Measure Participants	15
Mean (Full Range) [cm]	16

Adverse Events

Time Frame	12 month period of adverse event data collection.
Arm/Group Title	Endoscopic Gastric Restrictive Procedure
Arm/Group Description	Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.
All Cause Mortality
	Endoscopic Gastric Restrictive Procedure
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Endoscopic Gastric Restrictive Procedure
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Endoscopic Gastric Restrictive Procedure
	Affected / at Risk (%)	# Events
Total	7/20 (35%)
Gastrointestinal disorders
Perioperative Abdominal Pain	2/20 (10%)
Perioperative Nausea/Vomiting	3/20 (15%)
Post-operative Abdominal Pain	1/20 (5%)
Post-operative Nausea	1/20 (5%)

Limitations/Caveats

Early termination and withdrawal of 5 subjects leads to small numbers of subjects analyzed. No sham comparator. Durability measures at 12 month endoscopy was difficult to quantify.

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.