A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Obesity; Ulcerative Colitis
• Interventions: Device: Apollo Endoscopic Suture System; Behavioral: Lifestyle Intervention

• Registration Number: NCT05739162
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-22
• Study Start: 2023-09-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Sleeve Gastroplasty (ESG)	Apollo Endoscopic Suture System	Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.
Endoscopic Sleeve Gastroplasty (ESG)	Lifestyle Intervention	Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.

Primary Outcome Measures

Name	Time	Method
Percent total body weight loss	6 months	Percent total body weight loss (%TBWL) calculated by the equation ((baseline screening weight in kilograms (kg) subtracted by follow-up weight in kg) divided by baseline screening weight in kg) times 100.
Number of subjects with serious adverse events	24 months	Total number of subjects to report serious adverse event related to the ESG procedure

Secondary Outcome Measures

Name	Time	Method
Number of early peri-operative complications	1 year following procedure	Number of early (less than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure
Number of late peri-operative complications	1 year following procedure	Number of late (greater than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure
Change gastrointestinal symptom rating scale (GSRS)	Week 4, Week 12, Week 24, 12 months post-ileostomy takedown	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."
Modified pouchitis disease activity index (mPDAI)	12 months post-ileostomy takedown	Assess overall pouch function one year following ileostomy takedown using the modified pouchitis disease activity index (mPDAI) score. The mPDAI quantitates clinical symptoms and endoscopic features (edema, granularity, friability, loss of vascular pattern, mucus exudate, and ulceration) on several separate 0-2 point scores, whereby a total score greater than or equal to 5 is indicative of pouchitis.
Durable weight loss	12 months and 12 months post-ileostomy takedown	Number of subjects to achieve durable weight loss

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States