Clinical trial Recruiting at 9 sites Observational Ages 18 and up

PREcision MEDicine In Achalasia: How Long to Cut During POEM

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

Run by Northwestern University · NCT07293689 · Data updated 2026-11-12

This study looks at whether pre-procedure tests can help doctors decide how long to cut the esophageal muscle during POEM for adults with certain swallowing disorders.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorNorthwestern University
Academic / other
Drugs / interventionsradiation
Locations16 sites (Scottsdale, Arizona and 15 other locations)
StatusRecruiting
StartedDecember 1, 2026
Main results expectedAugust 31, 2031
Study endsAugust 31, 2032
Registry record updatedOctober 13, 2026
Trial IDNCT07293689 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 and older with Type III achalasia, EGJOO with spastic features, Jackhammer esophagus, or distal esophageal spasm who have not had POEM or other relevant surgeries within specified exclusions.

Probably not a fit

Patients who do not undergo POEM or whose care decisions are not influenced by pre-POEM testing may not experience a direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort gathers data from adults with Type III achalasia, EGJ outflow obstruction with spastic features, Jackhammer esophagus, or distal esophageal spasm to see if pre-POEM testing guides the length of myotomy. Researchers will access participants’ standard medical records and collect questionnaires up to six times over two years. No experimental treatment is performed; the study observes current care decisions and outcomes. The aim is to understand if pre-procedure testing influences the surgical approach and short- to mid-term results. Participation requires consent and aligns with routine clinical care in multiple tertiary centers.

Why it matters

Potential benefit: If successful, the findings could help tailor POEM techniques to improve symptom relief and safety for patients with esophageal motility disorders.

How similar studies have gone: Prior research in POEM and esophageal motility disorders has shown value in tailoring procedures, but this exact pre-POEM decision testing approach is being explored in this observational context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age ≥ 18
2. Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm
3. Eckardt Score \> 3

Exclusion Criteria:

* Exclusion:

  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

Where it's running

  • University of California San Diego
    La Jolla, California, United States
    Recruiting
  • University of Florida
    Gainesville, Florida, United States
    Recruiting
  • Emory University
    Atlanta, Georgia, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Washington University
    St Louis, Missouri, United States
    Recruiting
Show 10 more locations
  • Atrium Health/Wake Forest
    Charlotte, North Carolina, United States
    Recruiting
  • MetroHealth Medical Center
    Cleveland, Ohio, United States
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting
  • Mayo Clinic Arizona
    Scottsdale, Arizona, United States
    Not yet recruiting
  • University of Colorado Denver
    Denver, Colorado, United States
    Not yet recruiting
  • Adventist Health System/Sunbelt, Inc
    Orlando, Florida, United States
    Not yet recruiting
  • Johns Hopkins University
    Baltimore, Maryland, United States
    Not yet recruiting
  • Weill Cornell Medical College
    New York, New York, United States
    Not yet recruiting
  • Case Western Reserve University
    Cleveland, Ohio, United States
    Not yet recruiting
  • Baylor Scott & White Health
    Dallas, Texas, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.