Clinical Trial: Outcome Analysis of POEM and Endoluminal Therapies

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms

Brief Summary: Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.

Detailed Summary: Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.
Sponsor: University of California, Davis

Current Primary Outcome: Decrease in GERDDQ [ Time Frame: 3-6 months ]

Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)


Original Primary Outcome: Same as current

Current Secondary Outcome: Decrease in Eckardt scoring [ Time Frame: 30 days ]

Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)


Original Secondary Outcome: Same as current

Information By: University of California, Davis

Dates:
Date Received: April 5, 2016
Date Started: March 2016
Date Completion: December 2021
Last Updated: April 17, 2017
Last Verified: April 2017