PREcision MEDicine In Achalasia (PREMEDIA)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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 criteria

Qualifiers

Age ≥ 18

Type I achalasia or type II achalasia or cEGJOO

Eckardt score > 3

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard Myotomy
  • Tailored Short Myotomy

Treatment groups

372 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Northwestern University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator