Endoscopic Antral Myotomy for Weight Loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.