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

Running, not enrolling · Not applicable

Conditions studied: Obesity, Weight Loss, Delayed Gastric Emptying Following Procedure, Obesity, Mild, Obesity, Morbid, Obesity; Excess Calories

In brief

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.

Key facts

Study ID

NCT05713071

Run by

Brigham and Women's Hospital

People needed

20

Starts

2024-02-21

Expected to finish

2026-12-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Untreated H. pylori infection
• Active smoking
• Ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
• Previous pyloromyotomy or pyloroplasty
• Gastrointestinal obstruction
• Severe coagulopathy
• Esophageal or gastric varices and/or portal hypertensive gastropathy
• Pregnancy or puerperium
• 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)
• 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)
• Lactation
• History of gastrointestinal surgery
• Any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Chronic abdominal pain
• Active psychological issues preventing participation in a lifestyle modification program
• A known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
• An inability to provide informed consent
• Use of any medication that may interfere with weight loss
• Use of any medication that may interfere with gastric emptying
• Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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