Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Michele B. Ryan, MS
mryan@bwh.harvard.edu
6176765928
Time Frame
Start Date: 2023-09-22
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
PSAM Treatment Patients with no prior endoscopic bariatric therapies
Subjects with no prior endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.
PSAM Treatment Patients with prior primary endoscopic bariatric therapies
Subjects with prior primary endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.
PSAM Treatment Patients with prior revision endoscopic bariatric therapies
Subjects with prior revision endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.
Sponsors
Leads: Christopher C. Thompson, MD, MSc

This content was sourced from clinicaltrials.gov