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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-08-28)

PREcision MEDicine In Achalasia (PREMEDIA)

๐ŸŸข Recruiting Phase 3 ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Northwestern University

๐Ÿฉบ Protocol 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.

Primary Research Facility: Mayo Clinic Arizona (Scottsdale, Arizona)

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๐Ÿ“ Primary Site Map

Site: Mayo Clinic Arizona โ€” Scottsdale, Arizona

๐Ÿ“ All Participating Trial Locations (16 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Mayo Clinic Arizona โ€” Scottsdale, Arizona
2. University of California San Diego โ€” La Jolla, California
3. University of Colorado Denver โ€” Denver, Colorado
4. University of Florida โ€” Gainesville, Florida โ€ข Contact: (352) 273-9483
5. Adventist Health System/Sunbelt, Inc โ€” Orlando, Florida
6. Emory University โ€” Atlanta, Georgia โ€ข Contact: (404) 778-3184
7. Northwestern University โ€” Chicago, Illinois โ€ข Contact: (312) 926-4525
8. Johns Hopkins University โ€” Baltimore, Maryland
9. Massachusetts General Hospital โ€” Boston, Massachusetts โ€ข Contact: (617) 726-0196
10. Washington University โ€” St Louis, Missouri
11. Weill Cornell Medical College โ€” New York, New York
12. Atrium Health/Wake Forest โ€” Charlotte, North Carolina โ€ข Contact: (704) 355-2000
13. Case Western Reserve University โ€” Cleveland, Ohio
14. MetroHealth Medical Center โ€” Cleveland, Ohio โ€ข Contact: (216) 778-5736
15. Vanderbilt University Medical Center โ€” Nashville, Tennessee โ€ข Contact: (615) 322-4643
16. Baylor Scott & White Health โ€” Dallas, Texas

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07293650 โ€ข Last Synced: 2026-08-28
View on ClinicalTrials.gov โ†—
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