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
| Registry | NCT07293689, acronym PREMEDIA |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 200 (Estimated) |
| Sponsor | Northwestern University (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Conditions | Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features, Jackhammer Esophagus, Distal Esophageal Spasm |
| Dates | start 2026-12-01 (estimated), primary completion 2031-08-31 (estimated), completion 2032-08-31 (estimated), first posted 2025-12-19, last updated 2026-10-13 |
| Locations | 16 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Type III Achalasia All trials for EGJ Outflow Obstruction With Spastic/Hypercontractile Features
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.
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale, Arizona | United States | Not yet recruiting |
| University of California San Diego | La Jolla, California | United States | Recruiting |
| University of Colorado Denver | Denver, Colorado | United States | Not yet recruiting |
| University of Florida | Gainesville, Florida | United States | Recruiting |
| Adventist Health System/Sunbelt, Inc | Orlando, Florida | United States | Not yet recruiting |
| Emory University | Atlanta, Georgia | United States | Recruiting |
| Northwestern University | Chicago, Illinois | United States | Recruiting |
| Johns Hopkins University | Baltimore, Maryland | United States | Not yet recruiting |
| Massachusetts General Hospital | Boston, Massachusetts | United States | Recruiting |
| Washington University | St Louis, Missouri | United States | Recruiting |
| Weill Cornell Medical College | New York, New York | United States | Not yet recruiting |
| Atrium Health/Wake Forest | Charlotte, North Carolina | United States | Recruiting |
| Case Western Reserve University | Cleveland, Ohio | United States | Not yet recruiting |
| MetroHealth Medical Center | Cleveland, Ohio | United States | Recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee | United States | Recruiting |
| Baylor Scott & White Health | Dallas, Texas | United States | Not yet recruiting |