A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Ulcerative Colitis
• Intervention / Treatment: Device: Apollo Endoscopic Suture System; Behavioral: Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ESG with IPAA Study Team; Phone Number: 507-538-8238; Email: DLRSTIPAAinfo@mayo.edu
• Study Contact Backup: Name: Abigail A Stromme; Phone Number: 507-538-8238; Email: stromme.abigail@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Minnesota
      • Contact: Abigail A Stromme; Phone Number: 507-538-8238; Email: stromme.abigail@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endoscopic Sleeve Gastroplasty (ESG); 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; 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.; Behavioral: Lifestyle Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with serious adverse events	Total number of subjects to report serious adverse event related to the ESG procedure	24 months
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

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
Modified pouchitis disease activity index (mPDAI)	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.	12 months post-ileostomy takedown
Durable weight loss	Number of subjects to achieve durable weight loss	12 months and 12 months post-ileostomy takedown

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Amanda M Johnson, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: IPAA; ESG
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Overweight; Colitis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Colitis, Ulcerative
• Other Study ID Numbers: 22-007643

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes