Clinical trial

Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure

Recruiting now · Not applicable · 1 countries · Registry ID NCT05711758

Recruiting nowNot applicableObservational

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Obesity, Morbid, Obesity, Primary, Metabolic Disease, Delayed Gastric Emptying Following Procedure

Full registry 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

Treatments and study arms

PSAM Treatment Patients

Procedure

PSAM is a pylorus-sparing antral myotomy performed under general anesthesia. Endoscopic myotomy is then performed applying the principles of submucosal endoscopy and techniques used during gastric per-oral endoscopic myotomy (G-POEM). A submucosal bleb is created proximal to the pylorus. A longitudinal mucosal incision is made with an endoscopic knife. The endoscope is then introduced into the submucosal space, and the knife is used to dissect the submucosal fibers. Antral myotomy is performed starting proximal to the pyloric ring extending to the mucosal access site. The myotomy entails cutting of the inner circular and oblique muscle bundles or may be full thickness at the discretion of the endoscopist. The mucosal entry is then closed using endoscopic suturing or clips.

Primary outcomes

Weight change compared to baselineScreening, Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months

Percent total body weight loss

Adverse EventsProcedure day, 1 month, 3 month, 6 month, 9 month, 12 months

Changes to health compared to baseline

Change in tolerability from procedure day to 12 monthsProcedure day, 1 month, 3 month, 6 month, 9 month, 12 months

How the subjects feel after the procedure based on pain scale and AE's

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

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Michele B. Ryan, MSContact

Email · Call 6175258266

Christopher C. Thompson, MD, MScPrincipal Investigator