PREcision MEDicine In Achalasia (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
Northwestern University
372 participants
Apr 23, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Age ≥ 18
- Type I achalasia or type II achalasia or cEGJOO
- Eckardt score > 3
Exclusion Criteria16
- 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
- Weekly (or more frequent) opioid medication use in the last 2 years
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Interventions
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.
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07293650