Clinical Trial: Study of Hemospray for Lower Gastrointestinal Hemorrhage
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)
Brief Summary: This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.
Detailed Summary:
Sponsor: Cook
Current Primary Outcome: Percentage of device related adverse events [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of recurrent bleeding that occurs outside the blood vessel [ Time Frame: 30 days ]
- Percentage of hemostasis of lower GI bleeds originating from multiple sources [ Time Frame: 30 days ]
- All cause mortality [ Time Frame: 30 days ]Mortality within 30 days of index procedure
Original Secondary Outcome: Percentage of recurrent bleeding that occurs outside the blood vessel [ Time Frame: 30 days ]
Information By: Cook
Dates:
Date Received: March 26, 2014
Date Started: January 2015
Date Completion:
Last Updated: January 19, 2017
Last Verified: January 2017