A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

NCT05739162 | Recruiting FDA Device

• 1 other identifier: 22-007643
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 UC patients undergoing colectomy with eventual IPAA.

Conditions

Obesity; Ulcerative Colitis

Keywords

ESG; IPAA

Outcome Measures

Primary Outcomes (2)

• Percent total body weight loss

  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.

  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 Outcomes (5)

• Number of early peri-operative complications

  1 year following procedure

• Number of late peri-operative complications

  1 year following procedure

• Change gastrointestinal symptom rating scale (GSRS)

  Week 4, Week 12, Week 24, 12 months post-ileostomy takedown

• Modified pouchitis disease activity index (mPDAI)

  12 months post-ileostomy takedown

• Durable weight loss

  12 months and 12 months post-ileostomy takedown

Study Arms (1)

Endoscopic Sleeve Gastroplasty (ESG)

EXPERIMENTAL

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; Behavioral: Lifestyle Intervention

Interventions

Apollo Endoscopic Suture System DEVICE

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.

Endoscopic Sleeve Gastroplasty (ESG)

Lifestyle Intervention BEHAVIORAL

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.

Endoscopic Sleeve Gastroplasty (ESG)

Eligibility Criteria

• Age: 22 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Amanda M Johnson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ESG with IPAA Study Team

CONTACT

507-538-8238; DLRSTIPAAinfo@mayo.edu

Abigail A Stromme

CONTACT

507-538-8238; stromme.abigail@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: September 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)