PREcision MEDicine In Achalasia (PREMEDIA) - Cohort

NCT07293689 — Recruiting, 200 participants, Northwestern University

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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

RegistryNCT07293689, acronym PREMEDIA
StatusRecruiting
Study typeObservational
Enrollment200 (Estimated)
SponsorNorthwestern University (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ConditionsType III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features, Jackhammer Esophagus, Distal Esophageal Spasm
Datesstart 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
Locations16 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

-Summary

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.

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+Outcome measures

Primary outcomes

  • Clinical Response-Overall [From enrollment to Year 2]: Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.
  • Clinical Response-by Sex [From enrollment to Year 2]: Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.
  • Clinical Response-by Race [From Enrollment to Year 2]: Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.
  • Clinical Response-by Ethnicity [From Enrollment to Year 2]: Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

+Eligibility

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

+Locations (16)

FacilityCityCountryStatus
Mayo Clinic ArizonaScottsdale, ArizonaUnited StatesNot yet recruiting
University of California San DiegoLa Jolla, CaliforniaUnited StatesRecruiting
University of Colorado DenverDenver, ColoradoUnited StatesNot yet recruiting
University of FloridaGainesville, FloridaUnited StatesRecruiting
Adventist Health System/Sunbelt, IncOrlando, FloridaUnited StatesNot yet recruiting
Emory UniversityAtlanta, GeorgiaUnited StatesRecruiting
Northwestern UniversityChicago, IllinoisUnited StatesRecruiting
Johns Hopkins UniversityBaltimore, MarylandUnited StatesNot yet recruiting
Massachusetts General HospitalBoston, MassachusettsUnited StatesRecruiting
Washington UniversitySt Louis, MissouriUnited StatesRecruiting
Weill Cornell Medical CollegeNew York, New YorkUnited StatesNot yet recruiting
Atrium Health/Wake ForestCharlotte, North CarolinaUnited StatesRecruiting
Case Western Reserve UniversityCleveland, OhioUnited StatesNot yet recruiting
MetroHealth Medical CenterCleveland, OhioUnited StatesRecruiting
Vanderbilt University Medical CenterNashville, TennesseeUnited StatesRecruiting
Baylor Scott & White HealthDallas, TexasUnited StatesNot yet recruiting