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PREcision MEDicine In Achalasia (PREMEDIA)

Study acronym: PREMEDIA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 4 months later Apr 1, 2029 → Aug 2031
See other at-risk trials from Northwestern University

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 19 words
    • Site details revised at 5 of 16 sites
  2. Study sites: 15 to 16v8
  3. Site details revised at 1 of 15 sitesv7
  4. Study sites: 13 to 15v6
  5. Primary completion pushed from Apr 1, 2029 to Aug 2031
    • Study completion pushed from Mar 1, 2030 to Aug 1, 2032
    • Start date: Apr 23, 2026 to Apr 29, 2026
    v5
  6. Recruitment opened
    • Start date changed from estimate of Apr 1, 2026 to Apr 23, 2026
    • Site details revised at 13 of 13 sites
    v4
  7. Site contacts updated at 1 of 13 sitesv3
  8. Study description expanded, about 10 wordsv2
  9. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07293650
Lead Sponsor Northwestern University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Type I Achalasia, Type II Achalasia, EGJ Outflow Obstruction Without Spastic/Hypercontractile Features
Related terms Esophageal Achalasia
Enrollment 372 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov