Actively Recruiting
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Led by Christopher C. Thompson, MD, MSc · Updated on 2026-03-02
30
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The Pylorus Sparing Antral Myotomy (PSAM) technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body. PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability (GCSI score) or the safety profile of the procedure (2 DDW GEM abstracts). PSAM has not been evaluated alone, without concomitant ESG. Since delayed gastric emptying alone is known to promote weight loss, it is thought that PSAM alone (without ESG) may provide similar efficacy, while reducing procedure time and adverse events. There have been no clinical studies that investigate the efficacy of PSAM independent of ESG. This pilot study aims to address this lack of information by evaluating the safety, tolerability, and short-term efficacy of PSAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial.
CONDITIONS
Official Title
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Eligible for endoscopic and surgical weight loss procedures
- Body mass index (BMI) greater than 35 kg/m2
- Excellent mental health
- Ability to understand and sign informed consent
- Available for all routine follow-up study visits
You will not qualify if you...
- Untreated Helicobacter pylori infection
- Gastroparesis
- Active smoking
- Use of opioids in the past 12 months
- Previous pyloromyotomy or pyloroplasty
- Gastrointestinal obstruction
- Severe coagulopathy
- Esophageal or gastric varices or portal hypertensive gastropathy
- Pregnancy or puerperium
- Inflammatory diseases of the gastrointestinal tract (including severe esophagitis, active ulcers, or Crohn's disease)
- Malignant or premalignant gastric diseases (high-grade dysplasia, gastric cancer, GIST)
- Severe cardiopulmonary disease or recent coronary artery disease
- Lactation
- History of gastrointestinal surgery
- Serious health conditions unrelated to weight increasing endoscopy risk
- Chronic abdominal pain
- Active psychological issues preventing lifestyle modification
- Uncontrolled endocrine disorders affecting weight (e.g., hypothyroidism)
- Inability to provide informed consent
- Use of medications interfering with weight loss or gastric emptying
- Any other condition that may hinder study compliance or completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Michele B. Ryan, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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