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

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

September 22, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
ObesityObesity, MorbidObesity, PrimaryMetabolic DiseaseDelayed Gastric Emptying Following Procedure
Interventions
PROCEDURE

PSAM Treatment Patients

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.

Trial Locations (1)

02115

RECRUITING

Brigham and Women's Hospital, Boston

All Listed Sponsors
lead

Christopher C. Thompson, MD, MSc

OTHER