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PREcision MEDicine In Achalasia (PREMEDIA)
Sponsor: Northwestern University
Summary
The goal of this clinical trial is to learn if shorter Per-Oral Endoscopic Myotomy (POEM) works as well as a longer POEM in patients with trouble swallowing due to certain conditions. The main question\[s\] it aims to answer \[is/are\]: * Does making a smaller cut in the muscle at the bottom of the esophagus work just as well as making the standard bigger cut in relieving symptoms? * Does making the smaller cut reduce the side effects of the procedure compared to the standard bigger cut? Researchers will compare the symptoms and side effects of making a shorter cut to the symptoms and side effects of a longer cut. Participants will allow researchers to access their standard of care information in their medical record, complete questionnaires at up to 6 times over a 2-year period.
Official title: PREcision MEDicine In Achalasia - A Multicenter Randomized Non-Inferiority Clinical Trial of Short Tailored POEM vs. Standard POEM for Non-Spastic Achalasia and A Multicenter Prospective Cohort Study of Long Tailored POEM for Spastic Esophageal Motility Disorders
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
372
Start Date
2026-04-01
Completion Date
2030-03-01
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
Standard Myotomy
Myotomy during POEM of 8-10 cm in length, extending 2-3 cm into the gastric cardia; intention to perform selective circular myotomy, but allowing full thickness myotomy. FLIP is used to confirm adequate myotomy.
Tailored Short Myotomy
Myotomy during POEM of 4-5 cm in length, extending 1-2 cm into the gastric cardia; intend to perform selective circular myotomy, but allowing full thickness myotomy. FLIP is used to confirm adequate myotomy.
Locations (13)
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of California San Diego
La Jolla, California, United States
University of Colorado Denver
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
Adventist Health System/Sunbelt, Inc
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Scott & White Health
Dallas, Texas, United States