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
Boston Scientific Corporation
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.
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 m…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 no earlier than August 2021 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 i…
Interventions
- DeviceOverStitch™ 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.
- BehavioralLifestyle Modification
Patients participated in a lifestyle modification program for weight loss management.
Locations (3)
- BariendoMiami, Florida
- Brigham & Women's HospitalBoston, Massachusetts
- West Virginia UniversityMorgantown, West Virginia