Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity

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.

Inclusion Criteria:Subjects must be 18-70 years of ageAre currently in the CWMW lifestyle modification programHave a diagnostic endoscopy approved for bariatric evaluationEligible for endoscopic and surgical weight loss proceduresBody mass index (BMI) 30-50 kg/m2Individuals must be in excellent mental healthAble to understand and sign informed consentAvailable to return for all routine follow-up study visitsExclusion Criteria:Untreated H. pylori infectionActive smokingOngoing or a history of treatment with opioids in the last 12 months prior to enrollmentPrevious pyloromyotomy or pyloroplastyGastrointestinal obstructionSevere coagulopathyEsophageal or gastric varices and/or portal hypertensive gastropathyPregnancy or puerperiumAny inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)Malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)Severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)LactationHistory of gastrointestinal surgeryAny serious health condition unrelated to their weight that would increase the risk of endoscopyChronic abdominal painActive psychological issues preventing participation in a lifestyle modification programA known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)An inability to provide informed consentUse of any medication that may interfere with weight lossUse of any medication that may interfere with gastric emptyingAny other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.