Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06299644
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Sleeve Gastroplasty - Belt and Suspenders — DEVICE
    Endoscopic sleeve gastroplasty using belt and suspender plications.
  • Endoscopic Sleeve Gastroplasty - Belt — DEVICE
    Endoscopic sleeve gastroplasty using belt only plications.

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Nov 2025
Primary completion
Oct 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Belt and Suspenders Configuration
    Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).
  • Active Comparator: Belt Configuration
    Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).

Primary Outcome Measure

Percent TWL (%TWL) [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Brigham and Women's Hospital· Boston, MA

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