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NCT Number: NCT05739162

A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

22 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Percent total body weight loss

    Time frame: 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.

  2. Number of subjects with serious adverse events

    Time frame: 24 months

    Total number of subjects to report serious adverse event related to the ESG procedure

Secondary outcomes

  1. Number of early peri-operative complications

    Time frame: 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

  2. Number of late peri-operative complications

    Time frame: 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

  3. Change gastrointestinal symptom rating scale (GSRS)

    Time frame: 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."

  4. Modified pouchitis disease activity index (mPDAI)

    Time frame: 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.

  5. Durable weight loss

    Time frame: 12 months and 12 months post-ileostomy takedown

    Number of subjects to achieve durable weight loss

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Feb 22, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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