NCT06299644Not yet recruiting
Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 1 Feb 2024
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Obesity
- NCT number
- NCT06299644
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Sept 2026 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use
Other illness
- 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
Other
- 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
Who the study is looking for
- Patients with 18-65 years of age
- BMI ≥ 30 kg/m2
- Capable of giving informed consent and available to return for follow-up visit
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.