POEM-F for Achalasia International Study

This study is comparing a new procedure called POEM-F with the standard POEM (Per-oral endoscopic myotomy) procedure for people with achalasia. Achalasia is a condition where the esophagus (food pipe) has trouble moving food to the stomach. While POEM is effective, it can lead to acid reflux (GERD) in many patients. POEM-F is designed to reduce this reflux. Researchers want to see if POEM-F leads to less acid reflux one year after the procedure compared to conventional POEM. You may be able to join if you are an adult between 18 and 65 years old with symptomatic achalasia type I or II. The study aims to enroll 81 participants.

Study design
This is an interventional study comparing two procedures, POEM-F and Conventional POEM, with a planned enrollment of 81 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, gastroesophageal reflux, will be measured one year after the procedure.

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NCT06042127

POEM-F for Achalasia International Study

Recruiting
NAAges 18–65InterventionalTreatment
Chinese University of Hong Kong
~81 participants
Updated 2024-12-03 on ClinicalTrials.gov
What's tested:POEM-FConventional POEM

At a glance

Recruiting sites
1 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post-procedure rate of gastroesophageal reflux
Measured over 1 year
Achalasia
7 sites across 4 states
India4
Maryland1
China1
Hong Kong1
  • Hon Chi Yip, FRCSEd · PRINCIPAL_INVESTIGATOR · Chinese University of Hong Kong

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Treatment naïve, or
Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation
  • Post-procedure rate of gastroesophageal reflux1 year

    Defined by updated Lyon 2.0 consensus as fulfilling one or more of the criteria: 1. Endoscopic erosive esophagitis, LA grade B or above 2. Long segment Barrett's esophagus 3. Peptic esophageal stricture 4. 24-hour pH study with acid exposure time \>6% Both endoscopy and pH study to be performed with proton pump inhibitor stopped for 4 weeks