Clinical Trial

Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD

Study acronym: SFP-POEM
Not Yet Recruiting
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Summary
Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-10.
Trial Details
NCT Number NCT07178821
Lead Sponsor University of California, Irvine
Collaborators: Hoag Memorial Hospital Presbyterian, University of Ottawa, Vancouver General Hospital, Cedars-Sinai Medical Center
Conditions Achalasia, Esophageal, GERD (Gastroesophageal Reflux Disease)
Enrollment 120 participants
Start Date 2025-12-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-22