NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

PREcision MEDicine In Achalasia (PREMEDIA) - Cohort

RecruitingN/A

Sponsor: Northwestern University

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

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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

Locations (15)

Scottsdale, Arizona, United States
La Jolla, California, United States
Denver, Colorado, United States
Gainesville, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
New York, New York, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Dallas, Texas, United States