PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
PREMEDIA
1 other identifier
observational
200
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2026
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedStudy Start
First participant enrolled
August 31, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2031
Study Completion
Last participant's last visit for all outcomes
August 31, 2032
July 27, 2026
July 1, 2026
5 years
December 17, 2025
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Eligibility Criteria
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.
You may qualify if:
- Age ≥ 18
- Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm
- Eckardt Score \> 3
You may not qualify if:
- Prior POEM
- Prior surgical treatment for achalasia
- Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months
- Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy
- Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication
- Known secondary achalasia related to malignancy (pseudoachalasia)
- Known eosinophilic esophagitis
- Diverticulum (\> 2 cm) in distal esophagus
- Megaesophagus
- Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic)
- Pregnancy
- Standard contraindications to general anesthesia
- Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices)
- Unwillingness or inability to consent for the study
- Anticipated inability to follow protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
University of California San Diego
La Jolla, California, 92093, United States
University of Colorado Denver
Denver, Colorado, 80217, United States
University of Florida
Gainesville, Florida, 32611, United States
Adventist Health System/Sunbelt, Inc
Orlando, Florida, 32803, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Washington University
St Louis, Missouri, 63130, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Atrium Health/Wake Forest
Charlotte, North Carolina, 28204, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor Scott & White Health
Dallas, Texas, 75204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PRINCIPAL INVESTIGATOR (Contact PI)
Study Record Dates
First Submitted
December 17, 2025
First Posted
December 19, 2025
Study Start (Estimated)
August 31, 2026
Primary Completion (Estimated)
August 31, 2031
Study Completion (Estimated)
August 31, 2032
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR