Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05713071

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Weight Loss, Delayed Gastric Emptying Following Procedure, Obesity, Mild, Obesity, Morbid, Obesity; Excess Calories

Full registry criteria

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.

Treatments and study arms

Bariatric Endoscopic Antral Myotomy

Procedure

BEAM will be performed using a standard gastric peroral endoscopic myotomy (G-POEM) technique, however with the myotomy targeting only the antrum and leaving the pyloric ring intact. G-POEM is commonly and widely employed for gastric emptying and nutritional issues and is covered by most insurance plans. This involves injecting fluid into the submucosal space, making a mucosal incision to enter the submucosal space, and tunneling along the antrum to the pylorus. A myotomy is then performed, however, in BEAM the pyloric ring is spared and the myotomy is only performed in the antrum. The incision is then closed with clips. No endoscopic suturing will be performed.

Primary outcomes

Weight change compared to baselineScreening, Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months

percent total body weight loss

Adverse EventsDay 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months

Changes to health compared to baseline

Changed in pain scale from Day 0 to 12 monthsDay 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months

How the subjects feel after the procedure based on pain scale (no pain = 1- worst possible pain = 10)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

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