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NOT YET RECRUITING
NCT07293650
PHASE3

PREcision MEDicine In Achalasia (PREMEDIA)

Sponsor: Northwestern University

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.

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

Interventions

PROCEDURE

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.

PROCEDURE

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