Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Eligible age
18–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Christopher C. Thompson, MD, MSc
You may qualify if…
- ✓ subjects must be 18-70 years of age
- ✓ eligible for endoscopic and surgical weight loss procedures
- ✓ body mass index (BMI) greater than 35 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
- ✕ gastroparesis
- ✕ active smoking
- ✕ an 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
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT05711758 · last updated 2026-03-02