PREcision MEDicine In Achalasia (PREMEDIA) Study
This study, PREMEDIA, is looking at different ways to perform a procedure called Per-Oral Endoscopic Myotomy (POEM) for people with swallowing difficulties due to Type I achalasia, Type II achalasia, or EGJ outflow obstruction. Researchers want to see if a shorter POEM, where a smaller cut is made in the muscle at the bottom of the esophagus, works as well as the standard longer POEM. They will compare symptoms and side effects, hoping the shorter cut might lead to fewer problems like acid reflux. You could be eligible if you are 18 or older, have one of these conditions, and an Eckardt score (a measure of symptom severity) greater than 3. The study aims to enroll 372 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing two different POEM procedures. It plans to enroll 372 participants.
- What's involved
- You would allow researchers to access your medical records and complete questionnaires up to 6 times over a 2-year period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for clinical response from enrollment up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PREcision MEDicine In Achalasia (PREMEDIA)
At a glance
Conditions
Where it's being run
16 sites across 14 statesWho to contact
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What this trial measures
- Clinical Response-OverallFrom 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 SexFrom 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 RaceFrom 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 EthnicityFrom 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.