Clinical Trial: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

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

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

Brief Summary: This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.

Detailed Summary:
Sponsor: Ohio State University

Current Primary Outcome:

• Adverse Events related to POEM [ Time Frame: Intraoperative to one year follow-up ]
  To assess adverse events related to POEM
• Quality of life [ Time Frame: Baseline to one year follow-up ]
  To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up. It is expected that quality of life measures will improve post-POEM.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University

Dates:
Date Received: February 24, 2014
Date Started: August 2012
Date Completion:
Last Updated: September 22, 2015
Last Verified: September 2015