Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Patients with 18-65 years of age
BMI ≥ 30 kg/m2
Capable of giving informed consent and available to return for follow-up visit
Disqualifiers
Untreated H. pylori infection
Active gastric or duodenal ulceration
Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
Trial design
Treatments tested in this trial
- Endoscopic Sleeve Gastroplasty - Belt and Suspenders
- Endoscopic Sleeve Gastroplasty - Belt
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
Endo Tools Therapeutics S.A.
Collaborator
Source ClinicalTrials.gov