PREcision MEDicine In Achalasia (PREMEDIA) (NCT07293650) | Clinical Trial Compass
Not Yet RecruitingPhase 3
PREcision MEDicine In Achalasia (PREMEDIA)
United States372 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18
✓. Type I achalasia or type II achalasia or cEGJOO
✓. Eckardt score \> 3
Exclusion criteria
✕. 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)