Clinical trial

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Opening soon · Not applicable · 1 countries · Registry ID NCT06299644

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Obesity, Morbid, Metabolic Disease, Weight, Body

Full registry 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

Treatments and study arms

Endoscopic Sleeve Gastroplasty - Belt and Suspenders

Device

Endoscopic sleeve gastroplasty using belt and suspender plications.

Endoscopic Sleeve Gastroplasty - Belt

Device

Endoscopic sleeve gastroplasty using belt only plications.

Primary outcomes

Percent TWL (%TWL)Baseline, 6 months, 12 months

Change in the percent total weight loss from baseline at 6 and 12 months.

Adverse Events6 months, 12 months

Presence of adverse events that develop post-procedure

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

Open map