A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese ulcerative colitis (UC) patients undergoing colectomy with eventual Ileal Pouch Anal Anastomosis (IPAA) compared to counseling on diet and lifestyle interventions alone.

Official Title
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Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)

Conditions
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Obesity, Ulcerative Colitis

Intervention / Treatment
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* Device: Apollo Endoscopic Suture System
* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 30-50 kg/m2 for at least 6 months prior to ESG Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA) Willing to adhere to the diet and behavior modifications required for ESG Able to follow the visit schedule Able to provide informed consent If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline Exclusion Criteria: Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG Current or recent (last six months) gastric or duodenal ulceration Esophageal or gastric varices Significant motility disorder of the esophagus or stomach Large hiatal hernia measuring >5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux Severe coagulopathy, hepatic insufficiency, or cirrhosis Gastric mass Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits Unwilling to participate in an established diet and behavior modification program, with routine follow-up Ongoing corticosteroid use at a dose of >5 mg daily Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision Alcohol or drug addiction Females who are pregnant, nursing, or planning pregnancy within the next year Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Sleeve Gastroplasty (ESG)<br>Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention. | Device: Apollo Endoscopic Suture System<br>* Endoscopic Sleeve Gastroplasty (ESG), and endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 70-80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.<br>Behavioral: Lifestyle Intervention<br>* Low-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed.<br>|
| Active Comparator: Diet and Exercise<br>Participants receive lifestyle intervention only for 24 months | Behavioral: Lifestyle Intervention<br>* Low-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent total body weight loss | Percent total body weight loss (%TBWL) calculated by the equation ((visit 3 weight in kilograms (kg) subtracted by randomization weight in kg) divided by randomization weight in kg) times 100. | 6 months | 
| Number of subjects with serious adverse events | Total number of subjects to report serious adverse event related to the ESG procedure | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of early peri-operative complications | Number of early (less than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure | 1 year following procedure | 
| Number of late peri-operative complications | Number of late (greater than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure | 1 year following procedure | 
| Change gastrointestinal symptom rating scale (GSRS) | ESG tolerance measured by GSRS which includes 15 items and utilizes a 7-point response scale to measure a participant's level of discomfort associated with a given GI symptom, ranging from No discomfort at all to Very severe discomfort. | Week 4, Week 12, Week 24, 12 months post-ileostomy takedown | 
| Pouchitis disease activity index (PDAI) | Assess overall pouch function one year following ileostomy takedown using the pouchitis disease activity index (PDAI) score. The PDAI quantitates clinical symptoms and endoscopic and histological features (acute histological inflammation: crypt abscess and ulceration) on three separate six-point scores, whereby a total score higher than 7 is indicative of pouchitis. | 12 months post-ileostomy takedown | 
| Durable weight loss | Number of subjects to achieve durable weight loss | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESG, IPAA