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

NCT05713071 | Active Not Recruiting

• 1 other identifier: 2022P003399
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Bariatric Endoscopic Antral Myotomy (BEAM); Gastric physiology; Gastric emptying; Pylorus-sparing antral myotomy; Myotomy; Endoscopic Sleeve Gastroplasty (ESG); TransPyloric Shuttle (TPS); Intragastric balloon (IGB); Endoscopic bariatric and metabolic therapies (EBMT); Gut Hormones; Gastric Emptying Breath Test

Outcome Measures

Primary Outcomes (3)

• Weight change compared to baseline

  percent total body weight loss

  Screening, Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months

• Adverse Events

  Changes to health compared to baseline

  Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months

• Changed in pain scale from Day 0 to 12 months

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

  Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months

Secondary Outcomes (9)

• Change in Quality of Life compared to baseline using the Impact of Weight on Quality of Life Lite (IWQOL-Lite) Questionnaire

  Screening, 1 month, 3 month, 6 month, 9 month, 12 months

• Gastric Emptying compared to baseline

  Screening, 6 months, 12 months

• Ghrelin levels compared to baseline

  Screening, 6 months, 12 months

• Change in insulin metabolic profiles compared to baseline

  Screening, 6 months, 12 months

• Change in HgA1c levels compared to baseline

  Screening, 6 months, 12 months

Study Arms (2)

BEAM Treatment Patients

EXPERIMENTAL

Subjects having esophagogastroduodenoscopy (EGD) with Bariatric Endoscopic Antral Myotomy (BEAM) with standard of care lifestyle modification therapy.

Procedure: Bariatric Endoscopic Antral Myotomy

Lifestyle Modification Control Group

NO INTERVENTION

Standard of care lifestyle modification therapy only.

Interventions

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.

Also known as: BEAM

BEAM Treatment Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Erbe USA Incorporated: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (11)

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• Jia H, Lubetkin EI. Obesity-related quality-adjusted life years lost in the U.S. from 1993 to 2008. Am J Prev Med. 2010 Sep;39(3):220-7. doi: 10.1016/j.amepre.2010.03.026.

  PMID: 20709253 BACKGROUND

• McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.

  PMID: 31592891 BACKGROUND

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  PMID: 23711556 BACKGROUND

• Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.

  PMID: 27465076 BACKGROUND

• Hedjoudje A, Abu Dayyeh BK, Cheskin LJ, Adam A, Neto MG, Badurdeen D, Morales JG, Sartoretto A, Nava GL, Vargas E, Sui Z, Fayad L, Farha J, Khashab MA, Kalloo AN, Alqahtani AR, Thompson CC, Kumbhari V. Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 May;18(5):1043-1053.e4. doi: 10.1016/j.cgh.2019.08.022. Epub 2019 Aug 20.

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• Marinos G, Eliades C, Raman Muthusamy V, Greenway F. Weight loss and improved quality of life with a nonsurgical endoscopic treatment for obesity: clinical results from a 3- and 6-month study. Surg Obes Relat Dis. 2014 Sep-Oct;10(5):929-34. doi: 10.1016/j.soard.2014.03.005. Epub 2014 Mar 12.

  PMID: 25066439 BACKGROUND

• Aghaie Meybodi M, Qumseya BJ, Shakoor D, Lobner K, Vosoughi K, Ichkhanian Y, Khashab MA. Efficacy and feasibility of G-POEM in management of patients with refractory gastroparesis: a systematic review and meta-analysis. Endosc Int Open. 2019 Mar;7(3):E322-E329. doi: 10.1055/a-0812-1458. Epub 2019 Feb 28.

  PMID: 30842971 BACKGROUND

• Mohan BP, Chandan S, Jha LK, Khan SR, Kotagiri R, Kassab LL, Ravikumar NPG, Bhogal N, Chandan OC, Bhat I, Hewlett AT, Jacques J, Ponnada S, Asokkumar R, Adler DG. Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group. Surg Endosc. 2020 Aug;34(8):3352-3367. doi: 10.1007/s00464-019-07135-9. Epub 2019 Oct 3.

  PMID: 31583465 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss; Lymphoma, Follicular; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Christopher C. Thompson, MD, MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Model Details: 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 compared to lifestyle modification therapy alone. At 6 months control group will crossover to treatment group.

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: February 6, 2023
• Study Start: February 21, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)