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: 1. Subjects must be 18-70 years of age 2. Are currently in the CWMW lifestyle modification program 3. Have a diagnostic endoscopy approved for bariatric evaluation 4. Eligible for endoscopic and surgical weight loss procedures 5. Body mass index (BMI) 30-50 kg/m2 6. Individuals must be in excellent mental health 7. Able to understand and sign informed consent 8. Available to return for all routine follow-up study visits Exclusion Criteria: 1. Untreated H. pylori infection 2. Active smoking 3. Ongoing or a history of treatment with opioids in the last 12 months prior to enrollment 4. Previous pyloromyotomy or pyloroplasty 5. Gastrointestinal obstruction 6. Severe coagulopathy 7. Esophageal or gastric varices and/or portal hypertensive gastropathy 8. Pregnancy or puerperium 9. Any 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) 10. Malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST) 11. 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) 12. Lactation 13. History of gastrointestinal surgery 14. Any serious health condition unrelated to their weight that would increase the risk of endoscopy 15. Chronic abdominal pain 16. Active psychological issues preventing participation in a lifestyle modification program 17. A known history of endocrine disorders affecting weight (uncontrolled hypothyroidism) 18. An inability to provide informed consent 19. Use of any medication that may interfere with weight loss 20. Use of any medication that may interfere with gastric emptying 21. Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.