Endoscopic Antral Myotomy for Weight Loss
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure: A Pilot Study
This study is testing a new weight loss procedure called Pylorus Sparing Antral Myotomy to see if it helps people with obesity lose weight safely and effectively on its own.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05711758 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the efficacy and safety of the Pylorus Sparing Antral Myotomy (PSAM) technique as a standalone weight loss procedure. PSAM aims to delay gastric emptying to promote weight loss while minimizing procedure time and adverse events. The study will involve patients with obesity who are eligible for endoscopic and surgical weight loss procedures, assessing their safety, tolerability, and short-term efficacy. This approach is novel as it investigates PSAM independent of other interventions like endoscopic sleeve gastroplasty (ESG).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a BMI greater than 35 kg/m2 who are eligible for endoscopic and surgical weight loss procedures.
Not a fit: Patients with untreated H. pylori infection, active smoking habits, or a history of certain gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a new, effective option for weight loss in patients with obesity.
How similar studies have performed: While PSAM has been previously combined with ESG, this study is novel as it evaluates PSAM alone, with no prior clinical studies investigating its efficacy independently.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 * active psychological issues preventing participation in a lifestyle modification program * a known history of endocrine disorders affecting weight (uncontrolled hypothyroidism) * an inability to provide informed consent * use of any medication that may interfere with weight loss * use of any medication that may interfere with gastric emptying * any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christopher C. Thompson, MD, MSc — Brigham and Women's Hospital
- Study coordinator: Michele B. Ryan, MS
- Email: mryan@bwh.harvard.edu
- Phone: 6176765928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.