What this study is
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.
What's being tested
- Endoscopic Sleeve Gastroplasty - Belt and Suspenders
Intervention · DEVICE
Endoscopic sleeve gastroplasty using belt and suspender plications.
- Endoscopic Sleeve Gastroplasty - Belt
Intervention · DEVICE
Endoscopic sleeve gastroplasty using belt only plications.
Study details
- Official title
- Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
- Sponsor
- Brigham and Women's Hospital
- Conditions
- Obesity · Obesity, Morbid · Metabolic Disease · Weight, Body
- Enrolling
- 10 people
- Starts
- 2026-09
- Est. completion
- 2028-05
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients with 18-65 years of age
- BMI ≥ 30 kg/m2
- Capable of giving informed consent and available to return for follow-up visit
You can't join if
- 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
- Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
- Severe coagulopathy
- Active smoking
- Substance abuse
- Serious health condition that increased risk of anesthesia and/or endoscopic procedure
- Pregnancy or lactation
- Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBrigham and Women's Hospital
Boston, Massachusetts, United States
Study team
Sponsor
Brigham and Women's Hospital
Study ID 2023P003282
Principal investigator
Christopher C Thompson, MD, MSc
Brigham and Women's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.