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ACTIVE NOT RECRUITING
NCT05713071
NA

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-02-21

Completion Date

2026-05

Last Updated

2025-08-05

Healthy Volunteers

No

Interventions

PROCEDURE

Bariatric Endoscopic Antral Myotomy

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States