NCT05713071Active, not recruiting
Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 23 Dec 2022
- Start date
- 21 Feb 2024
- Primary completion date
- 26 Jun 2025
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Obesity
- NCT number
- NCT05713071
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 21 Feb 2024 to the primary completion date, 26 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
- Previous pyloromyotomy or pyloroplasty
- Use of any medication that may interfere with weight loss
- Use of any medication that may interfere with gastric emptying
Other illness
- Untreated H. pylori infection
- 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)
- History of gastrointestinal surgery
- Any serious health condition unrelated to their weight that would increase the risk of endoscopy
- A known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
- Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.
Other
- Active smoking
- Gastrointestinal obstruction
- Severe coagulopathy
- Esophageal or gastric varices and/or portal hypertensive gastropathy
- Pregnancy or puerperium
- Lactation
- Chronic abdominal pain
- Active psychological issues preventing participation in a lifestyle modification program
- An inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.