Trials / Recruiting
RecruitingNCT07190794
RESCUE: Discontinuation of GLP-1
Evaluation of Endoscopic Sleeve Gastroplasty (ESG) as an Alternative Weight Loss Strategy for Patients With Obesity Discontinuing GLP-1 Receptor Agonists Due to Intolerance or Ineffectiveness: A Retrospective Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to compare weight loss outcomes and safety of ESG versus lifestyle modification in patients with obesity who discontinued GLP-1 therapy due to intolerance or suboptimal weight loss.
Detailed description
This retrospective cohort study includes collection of data from medical records for consecutively treated patients undergoing treatment for weight loss following GLP-1 discontinuation. Weight loss treatment is either ESG with OverStitch™ OverStitch NXT™ or matched timeframe controls who participated in a lifestyle modification program for weight loss management. Subjects will be enrolled in a 2:1 ratio (ESG: Lifestyle modification) Patients are required to have the following visits for weight loss management: * Completed initial consultation visit (baseline) prior to initiation of weight management program with documented GLP-1 history and reason for discontinuation * Initiation of weight loss management no earlier than August 2021 * A minimum of two weight loss management visits, defined as performed by the physician that is managing the weight loss program and/or an affiliated weight loss specialist, completed at 1, 3, 6, or 9 months from the initiation of weight loss management * Completed 1-year weight loss management visit (as defined above)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OverStitch™ or OverStitch NXT™ | The OverStitch™ or OverStitch NXT™ Endoscopic Suturing System was used as part of each patient's ESG procedure within the routine clinical practice. |
| BEHAVIORAL | Lifestyle Modification | Patients participated in a lifestyle modification program for weight loss management. |
Timeline
- Start date
- 2025-12-17
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2025-09-24
- Last updated
- 2026-04-17
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07190794. Inclusion in this directory is not an endorsement.