Trial Outcomes & Findings for A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis (NCT NCT05739162)

Recruitment occurred at a single center, Mayo Clinic Rochester. Participants were identified using patient-matching tools to screen for potential eligibility. Individuals identified as potentially eligible were then contacted through approved outreach methods and invited to undergo further eligibility screening.

2 subjects were enrolled on the study, 1 of which screen failed prior to randomization. As only 1 participant was randomized in this study, no data is reported here in order to protect and maintain participant privacy/confidentiality.

A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

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.

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

Number of early (less than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure

Number of late (greater than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure

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."

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.

Number of subjects to achieve durable weight loss