PATHWAY: Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study

• Sponsor: Aspire Bariatrics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01766037
• Collaborator: Boston Medical Center (Other), Brigham and Women's Hospital (Other), Cornell University (Other), Howard University (Other), Mayo Clinic (Other), Northwestern University (Other), St. Mary Medical Center (Other), San Diego Veterans Healthcare System (U.S. Fed), University of Pennsylvania (Other), Washington University School of Medicine (Other)
• Enrollment: 171
• Locations: 10
• Arms: 2
• Actual Duration (Months): 76.5
• Patients Per Site: 17.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This research study is being performed to find out if a new device, AspireAssist Aspiration Therapy System, can help people with obesity to lose weight without causing too many side effects.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: Aspiration Therapy (AspireAssist); Behavioral: Lifestyle Therapy	N/A

Detailed Description

The Aspiration process works by "correcting" meal portions after eating by removing some of the food left in your stomach 20 minutes after your meal, which reduces the number of calories absorbed by your body. This is done through a tube placed through the abdomen into the stomach with a small valve attached at the surface of your skin. An aspiration system will attach to that valve after each major meal of the day and allow you to remove a portion of that meal.

During this study you will also be provided with Lifestyle therapy which includes behavioral therapy, diet and physical activity education. This Lifestyle therapy will also be provided to the participants who do not receive the AspireAssist so that the two groups can be compared and the benefit of aspiration for weight loss can be determined.

Study Design

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
• Actual Study Start Date: Nov 13, 2012
• Actual Primary Completion Date: Jun 24, 2015
• Actual Study Completion Date: Mar 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aspiration Therapy Aspiration Therapy and Lifestyle Therapy	Device: Aspiration Therapy (AspireAssist); Use of the AspireAssist device in aspiration therapy; Other Names: AspireAssist Aspiration Therapy System ; Behavioral: Lifestyle Therapy; Lifestyle therapy is a behavioral, diet and physical activity education program; Other Names: Lifestyle Behavioral Therapy
Active Comparator: Lifestyle Therapy Lifestyle Therapy only	Behavioral: Lifestyle Therapy; Lifestyle therapy is a behavioral, diet and physical activity education program; Other Names: Lifestyle Behavioral Therapy

Outcome Measures

Primary Outcome Measures

1. Mean Percent Excess Weight Loss (%EWL) [52 weeks]

   The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.

2. % of Subjects Who Achieve >25% EWL [52 weeks]

   The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL.

Secondary Outcome Measures

1. Mean Percent Total Body Weight Loss [52 weeks]

   i) Mean percent absolute weight loss in AT compared to Control group

2. Percent of Subjects With ≥10% Total Body Weight Loss [52 weeks]

   ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group

3. Mean Percent Change in Serum Lipids [52 weeks]

   iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group

4. Mean Percent Change in Blood Pressure [52 weeks]

   iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group

5. Mean Change in Score for IWQOL Questionnaire [52 weeks]

   v) "Impact of Weight on Quality of Life" (IWQOL) questionnaire total score Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients' IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI's between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points.

6. Mean Change in Hemoglobin A1C [52 weeks]

   vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint.

7. Procedural Success [52 weeks]

   vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy

8. Change in Medication for Hypertension [52 weeks]

   Percent change in the number of medications taken by subjects for hypertension

9. Change in Medications for Dyslipidemia [52 weeks]

   Percent change in the number of medications taken by subjects for dyslipidemia

10. Change in Medications for Type 2 Diabetes [52 weeks]

    Percent change in the number of medications taken by subjects for Type 2 Diabetes

11. Change in Number of Subjects on Hypertension Medication [52 weeks]

    Percent change in the number of subjects on Hypertension medication

12. Change in Number of Subjects on Dyslipidemia Medications [52 weeks]

    Percent change in the number of subjects on Dyslipidemia medications

13. Change in Number of Subjects on Diabetes Medication [52 weeks]

    Percent change in the number of subjects on Diabetes medication

Other Outcome Measures

1. Safety Outcomes [52 weeks]

   The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Measured BMI of 35.0-55.0 kg/m2 at time of screening.

2. 21- 65 years of age (inclusive) at time of screening.

3. Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs).

4. Stable weight (<3% change in self-reported weight) over the previous 3 months at time of screening).

5. Women of childbearing potential must agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, IUD, condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit.

6. Willing and able to provide informed consent in English and comply with the protocol.

Exclusion Criteria:

1. Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement

2. Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease

3. History of refractory gastric ulcers

4. Ulcers, bleeding lesions, or tumors discovered during endoscopic examination.

5. History of radiation therapy to the chest or abdomen

6. Uncontrolled hypertension (blood pressure >160/100).

7. Diabetes treated with insulin or sulfonylurea medications

8. Any change in diabetes medication in previous 3 months

9. Hemoglobin A1C >9.5%

10. History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or NYHA (New York Heart

Association) class III or IV heart failure (defined below):

Class III: patients with marked limitation of activity and who are comfortable only at rest Class IV: patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity

1. Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5)

2. Anemia (Hemoglobin <11.0 g/dL in women and <12.5 g/dL in men)

3. Liver enzymes (ALT and AST) ≥3.0 times the upper limit of normal

4. Thyroid Stimulating Hormone (TSH) >1.5 x upper limit of normal at screening.

5. Osteoporosis (DEXA T-Score ≤ -2.5 standard deviations below normal peak values).

6. History of fragility fractures (fractures resulting from a fall from a standing height or less, or presenting in the absence of obvious trauma)

7. Pregnant or lactating

8. Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria)

9. Night Eating Syndrome (diagnosed by EDE)

10. Serum potassium < 3.8 mEq/L

11. Chronic abdominal pain that would potentially complicate the management of the device

12. Taking a GLP-1 agonist < 6 months.

13. Taking prescription or over-the-counter medications for weight loss in the last 3 months before screening, or planning to participate in a commercial weight loss program in the next 24 months.

14. Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)

15. Self- reported history of substance abuse in last 3 years.

16. Malignancy in the last 5 years (except for non-melanoma skin cancer).

17. Physical or mental disability, or psychological illness that could interfere with compliance with the therapy.

18. At high risk of having a medical complication from the endoscopic procedure or Aspiration Therapy weight loss program for any reason, including poor general health or severe organ dysfunction, such as cirrhosis or renal dysfunction (GFR <60 mL/min/1.73 m2 at screening, calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept VA San Diego Health Care System	San Diego	California	United States	92161
2	Howard University Center for Wellness and Weight Loss Surgery	Washington	District of Columbia	United States	20060
3	Northwestern University	Chicago	Illinois	United States	60611
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
5	Boston Medical Center	Boston	Massachusetts	United States	02118
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
8	Weill Cornell Medical College	New York	New York	United States	10065
9	St. Mary Medical Center	Langhorne	Pennsylvania	United States	19047
10	University of Pennsylvania Center for Weight and Eating Disorders	Philadelphia	Pennsylvania	United States	19146

Sponsors and Collaborators

• Aspire Bariatrics, Inc.
• Boston Medical Center
• Brigham and Women's Hospital
• Cornell University
• Howard University
• Mayo Clinic
• Northwestern University
• St. Mary Medical Center
• San Diego Veterans Healthcare System
• University of Pennsylvania
• Washington University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Aspire Bariatrics, Inc. Study Sponsor Website

Publications

None provided.

• Responsible Party: Aspire Bariatrics, Inc.
• ClinicalTrials.gov Identifier: NCT01766037
• Other Study ID Numbers: P12-001V
• First Posted: Jan 11, 2013
• Last Update Posted: Jan 27, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Aspire Bariatrics, Inc.: obesity; obese; weight loss
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	First Subject Screened Oct 30, 2012; First Subject Enrolled Nov 13, 2012; Last Subject Enrolled June 13, 2014

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Period Title: Overall Study
STARTED	111	60
COMPLETED	82	31
NOT COMPLETED	29	29

Baseline Characteristics

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy	Total
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Total of all reporting groups
Overall Participants	111	60	171
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	111 100%	60 100%	171 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.4 (10.0)	46.8 (11.6)	43.9 (10.7)
Sex: Female, Male (Count of Participants)
Female	96 86.5%	53 88.3%	149 87.1%
Male	15 13.5%	7 11.7%	22 12.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 9.9%	11 18.3%	22 12.9%
Not Hispanic or Latino	99 89.2%	49 81.7%	148 86.5%
Unknown or Not Reported	1 0.9%	0 0%	1 0.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	33 29.7%	17 28.3%	50 29.2%
White	74 66.7%	42 70%	116 67.8%
More than one race	4 3.6%	1 1.7%	5 2.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	111 100%	60 100%	171 100%
Baseline Weight (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]	116.9 (21.2)	112.8 (16.1)	115.4 (19.6)

Outcome Measures

1. Primary Outcome

Title	Mean Percent Excess Weight Loss (%EWL)
Description	The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Modified Intent To Treat (mITT) population defined as all enrolled subjects

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	111	60
Mean (Standard Deviation) [Percent Excess Weight Loss]	31.5 (26.7)	9.8 (15.5)

2. Primary Outcome

Title	% of Subjects Who Achieve >25% EWL
Description	The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Modified Intent To Treat (mITT) population of all enrolled subjects

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	111	60
Number (95% Confidence Interval) [Percent of Subjects]	56.8	22.0

3. Secondary Outcome

Title	Mean Percent Total Body Weight Loss
Description	i) Mean percent absolute weight loss in AT compared to Control group
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Modified Intent To Treat (mITT) population of all enrolled subjects

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	111	60
Mean (Standard Deviation) [Percent Total Weight Loss]	12.1 (9.6)	3.6 (6.0)

4. Secondary Outcome

Title	Percent of Subjects With ≥10% Total Body Weight Loss
Description	ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Modified Intent To Treat (mITT) population of all enrolled subjects

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	111	60
Number (95% Confidence Interval) [Percent of Subjects]	58.6	11.9

5. Secondary Outcome

Title	Mean Percent Change in Serum Lipids
Description	iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects who completed 52 weeks

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	82	31
High Density Lipoprotein	8.1	1.7
Low Density Lipoprotein	-4.2	-1.8
Triglycerides	-9.9	0.1

6. Secondary Outcome

Title	Mean Percent Change in Blood Pressure
Description	iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects who completed 52 weeks

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	82	31
Systolic Pressure	-1.2	-2.5
Diastolic Pressure	-2.6	0.5

7. Secondary Outcome

Title	Mean Change in Score for IWQOL Questionnaire
Description	v) "Impact of Weight on Quality of Life" (IWQOL) questionnaire total score Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients' IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI's between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects who completed the Questionnaire at 52 weeks

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	81	27
Mean (95% Confidence Interval) [score on a scale]	16.3	11.7

8. Secondary Outcome

Title	Mean Change in Hemoglobin A1C
Description	vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects with Type 2 Diabetes

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	2	3
Mean (95% Confidence Interval) [DCCT% change]	-2.3	-0.37

9. Secondary Outcome

Title	Procedural Success
Description	vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

All A-Tube placement attempts

Arm/Group Title	Aspiration Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	112
Number [Percent Procedural Success]	99

10. Secondary Outcome

Title	Change in Medication for Hypertension
Description	Percent change in the number of medications taken by subjects for hypertension
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects being treated with medications for hypertension

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	29	20
Number [Percent Change in Medications]	-53.5	-9.4

11. Secondary Outcome

Title	Change in Medications for Dyslipidemia
Description	Percent change in the number of medications taken by subjects for dyslipidemia
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects being treated for high cholesterol

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	13	12
Number [Percent Change in Medications]	-23.1	-7.7

12. Secondary Outcome

Title	Change in Medications for Type 2 Diabetes
Description	Percent change in the number of medications taken by subjects for Type 2 Diabetes
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects being treated for Type 2 Diabetes

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	3	6
Number [Percent Change in Medications]	-33.0	-14.3

13. Secondary Outcome

Title	Change in Number of Subjects on Hypertension Medication
Description	Percent change in the number of subjects on Hypertension medication
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects being treated for hypertension

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	29	20
Number [% Change in Subjects on Medication]	-62.1	-10.0

14. Secondary Outcome

Title	Change in Number of Subjects on Dyslipidemia Medications
Description	Percent change in the number of subjects on Dyslipidemia medications
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects being treated for high cholesterol

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	13	12
Number [% Change in Subjects on Medication]	-23.1	-8.3

15. Secondary Outcome

Title	Change in Number of Subjects on Diabetes Medication
Description	Percent change in the number of subjects on Diabetes medication
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Subjects being treated for Type II Diabetes

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	3	6
Number [% Change in Subjects on Medication]	-33.3	-16.7

16. Other Pre-specified Outcome

Title	Safety Outcomes
Description	The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Modified Intent To Treat (mITT) population of all enrolled subjects

Arm/Group Title	Aspiration Therapy	Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program	Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
Measure Participants	111	60
Serious Adverse Event	3.6	0
Diagnosed Eating Disorder	0	1.7

Adverse Events

Time Frame	52 weeks
Arm/Group Title	Aspiration Therapy		Lifestyle Therapy
Arm/Group Description	Aspiration Therapy and Lifestyle Therapy Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program		Lifestyle Therapy only Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
All Cause Mortality
	Aspiration Therapy		Lifestyle Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Aspiration Therapy		Lifestyle Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/111 (3.6%)		0/60 (0%)
Gastrointestinal disorders
Abdominal Pain	1/111 (0.9%)	2	0/60 (0%)	0
Prepyloric Ulceration	1/111 (0.9%)	1	0/60 (0%)	0
Surgical and medical procedures
Peritonitis	1/111 (0.9%)	1	0/60 (0%)	0
A-Tube Replacement	1/111 (0.9%)	1	0/60 (0%)	0
Other (Not Including Serious) Adverse Events
	Aspiration Therapy		Lifestyle Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	93/111 (83.8%)		0/60 (0%)
Gastrointestinal disorders
Abdominal Pain (post procedure)	42/111 (37.8%)	42	0/60 (0%)	0
Nausea / Vomiting	21/111 (18.9%)	21	0/60 (0%)	0
Abdominal Discomfort	21/111 (18.9%)	21	0/60 (0%)	0
Abdominal Pain (after 4 weeks)	9/111 (8.1%)	9	0/60 (0%)	0
Change in Bowel Habits	5/111 (4.5%)	5	0/60 (0%)	0
Infections and infestations
Peristomal Infection	16/111 (14.4%)	16	0/60 (0%)	0
Skin and subcutaneous tissue disorders
Granulation Tissue	45/111 (40.5%)	45	0/60 (0%)	0
Peristomal Discharge	34/111 (30.6%)	34	0/60 (0%)	0

Limitations/Caveats

[Not Specified]

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.