Clinical Trial

PREcision MEDicine In Achalasia (PREMEDIA)

Study acronym: PREMEDIA
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2029-04-01 -> 2031-08 2026-07-22
minor Completion pushed: 2030-03-01 -> 2032-08-01 2026-07-22
critical Recruitment opened 2026-05-21
Trial Details
NCT Number NCT07293650
Lead Sponsor Northwestern University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type I Achalasia, Type II Achalasia, EGJ Outflow Obstruction Without Spastic/Hypercontractile Features
Enrollment 372 participants
Start Date 2026-04-29
Primary Completion 2031-08 (estimated)
Study Completion 2032-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-27