NCT05739162Active, not recruiting
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)
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 2 (actual)
- First submitted
- 13 Feb 2023
- Start date
- 20 Sept 2023
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Mayo Clinic
- Diseases
- Obesity, Ulcerative colitis
- NCT number
- NCT05739162
What you commit to
- Study type: Interventional
- Participants enrolled: 2
- From 20 Sept 2023 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG
- 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
- Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations
Other illness
- Significant motility disorder of the esophagus or stomach
- Severe coagulopathy, hepatic insufficiency, or cirrhosis
- 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
- 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
Other
- Current or recent (last six months) gastric or duodenal ulceration
- Esophageal or gastric varices
- Large hiatal hernia measuring \>5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux
- Gastric mass
- Unwilling to participate in an established diet and behavior modification program, with routine follow-up
- Females who are pregnant, nursing, or planning pregnancy within the next year
Who the study is looking for
- 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
Age in the registry: 22 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Minnesota Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.