PREcision MEDicine In Achalasia (PREMEDIA) - Cohort (PREMEDIA)

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yasmin Pina, BS; Phone Number: 312-503-6459; Email: yasmin.pina@northwestern.edu
• Study Contact Backup: Name: Elizabeth Yan, BS; Phone Number: 312-908-1723; Email: elizabeth.yan@northwestern.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Not yet recruiting
      • Mayo Clinic Arizona
  • California
    • La Jolla, California, United States, 92093
      • Not yet recruiting
      • University of California San Diego
  • Colorado
    • Denver, Colorado, United States, 80217
      • Not yet recruiting
      • University of Colorado Denver
  • Florida
    • Gainesville, Florida, United States, 32611
      • Not yet recruiting
      • University of Florida
    • Orlando, Florida, United States, 32803
      • Not yet recruiting
      • Adventist Health System/Sunbelt, Inc
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Principal Investigator: John Pandolfino, MD
      • Contact: Phone Number: 312-926-4525; Email: PREMEDIA@northwestern.edu
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Not yet recruiting
      • Johns Hopkins University
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Not yet recruiting
      • Washington University
  • New York
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Weill Cornell Medical College
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Case Western Reserve University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Not yet recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75204
      • Not yet recruiting
      • Baylor Scott & White Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Achalasia, EGJOO, and other spastic motility disorders are relatively rare and have substantial quality of life implications (see Protocol and Research Strategy for details). Given the prevalence and severity of these conditions, it is uncommon for patients with symptoms to not seek some form of treatment. Thus, we expect much of the recruitment to occur directly from site clinics, which include prominent esophageal motility experts and have robust referral networks, as patients seek care. A review of POEM procedure logs from participating CCs reveals that likely eligible patients are on average about 55-65 years old. We anticipate that the ethnic and racial distribution of our study group will be similar to prior achalasia studies with 25% African American, 10% Hispanic and 65% Caucasian.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response-Overall	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.	From enrollment to Year 2
Clinical Response-by Sex	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.	From enrollment to Year 2
Clinical Response-by Race	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.	From Enrollment to Year 2
Clinical Response-by Ethnicity	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.	From Enrollment to Year 2

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: achalasia; EGJOO
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Achalasia
• Other Study ID Numbers: PREMEDIA (Pro00083748) - 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No