PREcision MEDicine In Achalasia (PREMEDIA)
Recruiting now · Phase 3
Conditions studied: Type I Achalasia, Type II Achalasia, EGJ Outflow Obstruction Without Spastic/Hypercontractile Features
In brief
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.
Key facts
- Study ID
- NCT07293650
- Run by
- Northwestern University
- People needed
- 372
- Starts
- 2026-04-29
- Expected to finish
- 2032-08-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18
- Type I achalasia or type II achalasia or cEGJOO
- Eckardt score > 3
You may not qualify if…
- The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study:
- Prior POEM
- Prior surgical treatment for achalasia
- Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months
- Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy
- Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication
- Known secondary achalasia related to malignancy (pseudoachalasia)
- Known eosinophilic esophagitis
- Diverticulum (> 2 cm) in distal esophagus
- Megaesophagus
- Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic)
- Pregnancy
- Standard contraindications to general anesthesia
- Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices)
- Unwillingness or inability to consent for the study
- Anticipated inability to follow protocol
- Weekly (or more frequent) opioid medication use in the last 2 years
Where it is running
- Northwestern University — Chicago, Illinois, United States (enrolling)
- MetroHealth Medical Center — Cleveland, Ohio, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Atrium Health/Wake Forest — Charlotte, North Carolina, United States (enrolling)
- Adventist Health System/Sunbelt, Inc — Orlando, Florida, United States
- Emory University — Atlanta, Georgia, 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
- Mayo Clinic Arizona — Scottsdale, Arizona, United States
- Baylor Scott & White Health — Dallas, Texas, 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
Full record on ClinicalTrials.gov
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