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