Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

NCT06299644 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-02

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299644 on ClinicalTrials.gov