Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: 1. Patients with 18-65 years of age 2. BMI ≥ 30 kg/m2 3. Capable of giving informed consent and available to return for follow-up visit Exclusion Criteria: 1. Untreated H. pylori infection 2. Active gastric or duodenal ulceration 3. Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST)) 4. Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D) 5. Esophageal or gastric varices and/or portal hypertensive gastropathy 6. Gastroparesis 7. History of gastric surgery/endoscopic procedure 8. Active psychological issues preventing participation in a lifestyle modification program 9. Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism) 10. Severe coagulopathy 11. Active smoking 12. Substance abuse 13. Serious health condition that increased risk of anesthesia and/or endoscopic procedure 14. Pregnancy or lactation 15. Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use
Study sites (1)
MA
- Brigham and Women's Hospital · Boston, MA 02115More trials in Boston