Not Yet RecruitingNot Applicable

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

United States10 participantsStarted 2026-09

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Patients with 18-65 years of age
✓. BMI ≥ 30 kg/m2
✓. Capable of giving informed consent and available to return for follow-up visit

Exclusion criteria

✕. Untreated H. pylori infection
✕. Active gastric or duodenal ulceration
✕. Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
✕. Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
✕. Esophageal or gastric varices and/or portal hypertensive gastropathy
✕. Gastroparesis
✕. History of gastric surgery/endoscopic procedure
✕. Active psychological issues preventing participation in a lifestyle modification program

What they're measuring

Percent TWL (%TWL)

Timeframe: Baseline, 6 months, 12 months

Adverse Events

Timeframe: 6 months, 12 months

Trial details

NCT IDNCT06299644

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Michele B Ryan, MS

617-525-8266 mryan@bwh.harvard.edu

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