A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis (NCT05739162) | Clinical Trial Compass
RecruitingNot Applicable
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
United States12 participantsStarted 2023-09-20
Plain-language 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.
Who can participate
Age range22 Years ā 69 Years
SexALL
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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, witā¦