Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT07190794
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESCUE: Discontinuation of GLP-1
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 between August 2021 and September 2024
* 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)
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 between August 2021 and September 2024
* 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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: