Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
NCT06299644 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-12-02
Summary
The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.
Conditions
- Obesity
- Obesity, Morbid
- Metabolic Disease
- Weight, Body
Interventions
- DEVICE
-
Endoscopic Sleeve Gastroplasty - Belt and Suspenders
Endoscopic sleeve gastroplasty using belt and suspender plications.
- DEVICE
-
Endoscopic Sleeve Gastroplasty - Belt
Endoscopic sleeve gastroplasty using belt only plications.
Sponsors & Collaborators
-
Endo Tools Therapeutics S.A.
collaborator INDUSTRY -
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Christopher C Thompson, MD, MSc · Brigham and Women's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-10-31
- Completion
- 2028-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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