PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Recruiting now
Conditions studied: Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features, Jackhammer Esophagus, Distal Esophageal Spasm
In brief
The goal of this observational study is to learn about how the doctor decides how long to cut t the esophageal muscle during Per-Oral Endoscopic Myotomy (POEM) in patients with difficulty swallowing due to certain conditions. The main question it aims to answer is: does pre-POEM testing help the physician choose how long to cut the muscle. 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
- NCT07293689
- Run by
- Northwestern University
- People needed
- 200
- Starts
- 2026-12-01
- Expected to finish
- 2032-08-31
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18
- Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm
- Eckardt Score > 3
You may not qualify if…
- Exclusion:
- 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
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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