Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
Brigham and Women's Hospital
Summary
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.
Description
Obesity is a major global health concern. In the US, from 1999 through 2020, the prevalence of obesity has increased from 30.5% to 41.9%. Obesity, defined as the body mass index of more than 30 kg/m2, increases the risk of metabolic diseases and has become the leading cause of death including cardiovascular disease, stroke and cancers. At present, obesity treatment ranges from lifestyle modification, pharmacotherapy, endoscopic to surgical intervention. Though bariatric surgery has proven to be the most effective treatment in terms of weight loss, it still carries the complication rates of 0.…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 ga…
Interventions
- DeviceEndoscopic Sleeve Gastroplasty - Belt and Suspenders
Endoscopic sleeve gastroplasty using belt and suspender plications.
- DeviceEndoscopic Sleeve Gastroplasty - Belt
Endoscopic sleeve gastroplasty using belt only plications.
Location
- Brigham and Women's HospitalBoston, Massachusetts