Endoscopic Sleeve Gastroplasty Techniques for Obesity

Recruiting in Palo Alto (17 mi)

Christopher C. Thompson, MD - Brigham ...

Overseen byChristopher Thompson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for individuals struggling with obesity who are looking to lose weight. Participants should be adults willing to undergo an endoscopic procedure, but those with certain gastrointestinal conditions or previous stomach surgeries may not qualify.

Inclusion Criteria

I am between 18 and 65 years old.

BMI ≥ 30 kg/m2

Capable of giving informed consent and available to return for follow-up visit

Exclusion Criteria

I have a thyroid condition that affects my weight and it's not under control.

I have an untreated H. pylori infection.

Substance abuse

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Treatment Details

Interventions

Endoscopic Sleeve Gastroplasty - Belt (Procedure)
Endoscopic Sleeve Gastroplasty - Belt and Suspenders (Procedure)

Trial OverviewThe study is testing two techniques of Endoscopic Sleeve Gastroplasty (ESG) using the Endomina system: one called 'Belt' and another 'Belt and Suspenders'. The goal is to see which method leads to more weight loss.

Participant Groups

2Treatment groups

Active Control

Group I: Belt and Suspenders ConfigurationActive Control1 Intervention

Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).

Group II: Belt ConfigurationActive Control1 Intervention

Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).