Comparing two stitch patterns for endoscopic stomach-sleeve weight loss
Compares two stitching patterns for an endoscopic stomach-sleeve procedure in adults with obesity.
Key facts
- Who runs it
- Brigham and Women's Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Registry title
- Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
- Status
- Not yet recruiting
- People taking part
- 10 people, planned
- Started
- Sept 2026
- Expected to end
- May 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Endoscopic Sleeve Gastroplasty - Belt and Suspenders
- Endoscopic Sleeve Gastroplasty - Belt
- Record updated
- 2 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with obesity (BMI of 30 kg/m2 or more) who can give consent and come back for follow-up. It compares two stitching patterns in a stomach sleeve procedure done with an endoscope.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Obesity with a BMI of 30 kg/m2 or more.
- Earlier treatment
- People who have had stomach surgery or a stomach endoscopic procedure cannot join.
Main reasons for not taking part
- Untreated H. pylori infection, active stomach or duodenal ulcer, or stomach disease that is cancer or may become cancer
- Severe reflux esophagitis (LA Grade C or D), esophageal or gastric varices, or gastroparesis
- Previous stomach surgery or endoscopic procedure
- Severe coagulopathy, or a serious health condition that raises the risk of anesthesia or the procedure
- Active smoking, substance abuse, pregnancy or breastfeeding, or need for NSAID medicines
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Patients with 18-65 years of age
- BMI ≥ 30 kg/m2
- Capable of giving informed consent and available to return for follow-up visit
Who cannot take part
- Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use
- Untreated H. pylori infection
- Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
- History of gastric surgery/endoscopic procedure
- Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
- Serious health condition that increased risk of anesthesia and/or endoscopic procedure
- Active gastric or duodenal ulceration
- Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
- Esophageal or gastric varices and/or portal hypertensive gastropathy
- Gastroparesis
- Active psychological issues preventing participation in a lifestyle modification program
- Severe coagulopathy
- Active smoking
- Substance abuse
- Pregnancy or lactation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- Brigham and Women's HospitalBoston, United StatesContact: Michele B Ryan, MSNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Belt and Suspenders ConfigurationExisting treatment, for comparison
Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).
Treatment: Endoscopic Sleeve Gastroplasty - Belt and Suspenders
- Belt ConfigurationExisting treatment, for comparison
Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).
Treatment: Endoscopic Sleeve Gastroplasty - Belt
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
- Plain-language title
- Comparing two stitch patterns for endoscopic stomach-sleeve weight lossGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06299644, who can take part
- Record updated
- 2 December 2025