This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.
Study Type
OBSERVATIONAL
Enrollment
50
The Hemospray™ device comes in a 7F kit and a 10F kit. Each kit includes two 220 cm Teflon application catheters, a handle with CO2 cartridge and a syringe containing approximately 20 g of the Hemospray™ material. Hemospray™ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa.
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Hotel Dieu Hospital
Kingston, Ontario, Canada
Montreal General Hospital - McGill University
Montreal, Quebec, Canada
Percentage of device related adverse events
Time frame: 30 days
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
Mortality within 30 days of index procedure
Time frame: 30 days
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