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Not yet recruiting NCT07293689

PREcision MEDicine In Achalasia (PREMEDIA) - Cohort

Conditions: Type III Achalasia EGJ Outflow Obstruction With Spastic/Hypercontractile Features Jackhammer Esophagus Distal Esophageal Spasm

Sponsor: Northwestern University

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 13
United States (13)
Emory University
Atlanta , Georgia
Johns Hopkins University
Baltimore , Maryland
Northwestern University
Chicago , Illinois
Case Western Reserve University
Cleveland , Ohio
Baylor Scott & White Health
Dallas , Texas
University of Colorado Denver
Denver , Colorado
University of Florida
Gainesville , Florida
University of California San Diego
La Jolla , California
Vanderbilt University Medical Center
Nashville , Tennessee
Weill Cornell Medical College
New York , New York
Adventist Health System/Sunbelt, Inc
Orlando , Florida
Mayo Clinic Arizona
Scottsdale , Arizona
Washington University
St Louis , Missouri
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.03.2030
Registry ID
NCT07293689
Source
clinicaltrials.gov
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