Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT07190794
Eligibility Criteria:
Inclusion Criteria:
1. Adults (≥ 18 years)
2. BMI ≥30 kg/m² and ≤ 50 kg/m2
3. Discontinued GLP-1 therapy for weight loss (semaglutide and tirzepatide only) for intolerance or suboptimal weight loss (\<5% TBWL after 3 months at maximally tolerated dose)
4. Initiation of weight loss management between August 2021 and September 2024
5. Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment
6. Completed at least two interim visits for weight loss management from 1, 3, 6, through 9 months following initiation of weight loss treatment
Exclusion Criteria:
1. Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason
2. History of GLP-1 medication for a reason other than weight management
3. Had bariatric surgery or an endoscopic procedure for weight loss treatment other than ESG with OverStitch™ or OverStitch NXT™ within 1 year of starting weight loss management
4. Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results
5. Had another weight loss treatment during the 1-year follow-up reported during this study. Weight loss treatment includes but is not limited to appetite suppressants, anti-obesity medications, plastic surgery or body contouring procedures.
6. Pregnancy during the 1 year following initiation of weight loss management
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07190794
Study Brief:
Protocol Section:
NCT07190794