Clinical Trial: Evaluation of a Novel Endoscopic Treatment for Achalasia

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

Official Title: Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)

Brief Summary: This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.

Detailed Summary: This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.
Sponsor: University Hospitals Cleveland Medical Center

Current Primary Outcome: The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure [ Time Frame: Within the first 3 months after surgery ]

Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospitals Cleveland Medical Center

Dates:
Date Received: January 15, 2013
Date Started: June 2012
Date Completion:
Last Updated: June 16, 2014
Last Verified: June 2014