Status:
NOT_YET_RECRUITING
Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Hoag Memorial Hospital Presbyterian
University of Ottawa
Conditions:
Achalasia, Esophageal
GERD (Gastroesophageal Reflux Disease)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 gast...
Detailed Description
Achalasia is a rare esophageal motility disorder treated effectively with peroral endoscopic myotomy (POEM). However, post-procedure gastroesophageal reflux disease (GERD) is a common complication, re...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Participants must meet all of the following):
- Age ≥ 18 years
- Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0
- Deemed appropriate candidates for POEM
- Ability to provide informed consent
- Exclusion Criteria (Participants will be excluded if any of the following apply):
- Spastic motility disorders other than achalasia type I-III (e.g. diffuse esophageal spasm, jackhammer esophagus, EGJ outflow obstruction)
- Sigmoid esophagus
- Prior surgical myotomy (e.g., Heller myotomy)
- Contraindications to endoscopy or general anesthesia
- Pregnancy or actively breastfeeding
- Significant cardiopulmonary comorbidities that preclude safe endoscopic intervention
- Coagulopathy or portal hypertension
- Unwillingness or inability to complete follow-up assessments
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07178821
Start Date
December 1 2025
End Date
January 1 2028
Last Update
October 22 2025
Active Locations (1)
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1
University of California, Irvine - UCI Medical Center
Orange, California, United States, 92868