Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
150 participants
OBSERVATIONAL
2025-11-30
2026-06-30
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ESG Recipients
After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment.
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.
Lifestyle Modification
After discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program.
Lifestyle Modification
Patients participated in a lifestyle modification program for weight loss management.
Interventions
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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.
Lifestyle Modification
Patients participated in a lifestyle modification program for weight loss management.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Pichamol Jirapinyo, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Bariendo
Miramar, Florida, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Pichamol Jirapinyo, MD, MPH
Role: primary
Michele Ryan
Role: primary
Other Identifiers
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E7234
Identifier Type: -
Identifier Source: org_study_id