PREcision MEDicine In Achalasia (PREMEDIA)
PREMEDIA
1 other identifier
interventional
372
1 country
15
Brief Summary
The goal of this clinical trial is to learn if shorter Per-Oral Endoscopic Myotomy (POEM) works as well as a longer POEM in patients with trouble swallowing due to certain conditions. The main question\[s\] it aims to answer \[is/are\]:
- Does making a smaller cut in the muscle at the bottom of the esophagus work just as well as making the standard bigger cut in relieving symptoms?
- Does making the smaller cut reduce the side effects of the procedure compared to the standard bigger cut? Researchers will compare the symptoms and side effects of making a shorter cut to the symptoms and side effects of a longer cut. 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 P50-P75 for phase_3
Started Apr 2026
Longer than P75 for phase_3
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
April 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2032
July 27, 2026
July 1, 2026
5.3 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
Study Arms (2)
Standard Myotomy
ACTIVE COMPARATORTailored Short Myotomy
EXPERIMENTALInterventions
Myotomy during POEM of 8-10 cm in length, extending 2-3 cm into the gastric cardia; intention to perform selective circular myotomy, but allowing full thickness myotomy. FLIP is used to confirm adequate myotomy.
Myotomy during POEM of 4-5 cm in length, extending 1-2 cm into the gastric cardia; intend to perform selective circular myotomy, but allowing full thickness myotomy. FLIP is used to confirm adequate myotomy.
Eligibility Criteria
You may qualify if:
- Age ≥ 18
- Type I achalasia or type II achalasia or cEGJOO
- 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
- +1 more criteria
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
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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
April 29, 2026
Primary Completion (Estimated)
August 1, 2031
Study Completion (Estimated)
August 1, 2032
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR