Clinical Trial: The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia

Brief Summary:

Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.

The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.


Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: Number of participants with adverse events [ Time Frame: 5 years post surgery ]

Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.


Original Primary Outcome: Number of participants with adverse events [ Time Frame: 5 years post surgery ]

Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckhard symptom score, barium esophagram, and manometry studies.


Current Secondary Outcome: Eckardt symptom score [ Time Frame: 5 years ]

By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure.


Original Secondary Outcome: Eckhard symptom score [ Time Frame: 5 years ]

By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict reponse to the POEMS procedure.


Information By: Mayo Clinic

Dates:
Date Received: January 12, 2012
Date Started: January 2012
Date Completion:
Last Updated: October 27, 2016
Last Verified: October 2016