Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity (NCT05713071) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity
United States20 participantsStarted 2024-02-21
Plain-language summary
In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin).
This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Subjects must be 18-70 years of age
✓. Are currently in the CWMW lifestyle modification program
✓. Have a diagnostic endoscopy approved for bariatric evaluation
✓. Eligible for endoscopic and surgical weight loss procedures
✓. Body mass index (BMI) 30-50 kg/m2
✓. Individuals must be in excellent mental health
✓. Able to understand and sign informed consent
✓. Available to return for all routine follow-up study visits
Exclusion criteria
✕. Untreated H. pylori infection
✕. Active smoking
✕. Ongoing or a history of treatment with opioids in the last 12 months prior to enrollment