PREcision MEDicine In Achalasia (PREMEDIA) (NCT07293650)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona โ Scottsdale, Arizona
Age range: 18 Years
๐งช Interventions in This Study
- Standard Myotomy (PROCEDURE)
- Tailored Short Myotomy (PROCEDURE)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (16 Sites)
- Mayo Clinic Arizona โ Scottsdale, Arizona
- University of California San Diego โ La Jolla, California
- University of Colorado Denver โ Denver, Colorado
- University of Florida โ Gainesville, Florida
- Adventist Health System/Sunbelt, Inc โ Orlando, Florida
- Emory University โ Atlanta, Georgia
- Northwestern University โ Chicago, Illinois
- Johns Hopkins University โ Baltimore, Maryland
- Massachusetts General Hospital โ Boston, Massachusetts
- Washington University โ St Louis, Missouri
- Weill Cornell Medical College โ New York, New York
- Atrium Health/Wake Forest โ Charlotte, North Carolina
- Case Western Reserve University โ Cleveland, Ohio
- MetroHealth Medical Center โ Cleveland, Ohio
- Vanderbilt University Medical Center โ Nashville, Tennessee
- Baylor Scott & White Health โ Dallas, Texas
๐ Contact the Study Coordinator
Phone: (312) 908-1723
Email: premedia.dcc@northwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Type I Achalasia clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.