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PREcision MEDicine In Achalasia (PREMEDIA)

RecruitingPhase 3Ages 18 Years - anyAllNorthwestern University
NCT07293650 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Age ≥ 18 2. Type I achalasia or type II achalasia or cEGJOO 3. Eckardt score \> 3 Exclusion Criteria The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study: 1. Prior POEM 2. Prior surgical treatment for achalasia 3. Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months 4. Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy 5. Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication 6. Known secondary achalasia related to malignancy (pseudoachalasia) 7. Known eosinophilic esophagitis 8. Diverticulum (\> 2 cm) in distal esophagus 9. Megaesophagus 10. Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic) 11. Pregnancy 12. Standard contraindications to general anesthesia 13. Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices) 14. Unwillingness or inability to consent for the study 15. Anticipated inability to follow protocol 16. Weekly (or more frequent) opioid medication use in the last 2 years
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What it tests

  • Standard Myotomy
  • Tailored Short Myotomy
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Where

16 sites
Mayo Clinic Arizona
Scottsdale, United States
University of California San Diego
La Jolla, United States
University of Colorado Denver
Denver, United States
University of Florida
Gainesville, United States
Adventist Health System/Sunbelt, Inc
Orlando, United States
Emory University
Atlanta, United States
Northwestern University
Chicago, United States
Johns Hopkins University
Baltimore, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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