At a glance
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Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique
In Brief
A Phase 2 clinical trial evaluating Hybrid Knife for Achalasia. Completed, enrolled 10 participants across 1 site.
Detailed Summary
Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is performed, and has advantage over surgery because it is performed endoscopically, thus is less invasive. One potential disadvantage in respect to surgery may be that it may determine higher rates of post-operative reflux. The purpose of this study is to prospectively assess the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3 and 12 months. This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will be included for the POEM procedure. This study will last about 2 years. The aim is the feasibility, security and success rate of POEM for achalasia. Patients will be followed for at least one year.
Study Details
Timeline
Interventions
POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.