Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding
- Conditions
- Bleeding Peptic Ulcers
- Interventions
- Device: Hemospray Kit
- Registration Number
- NCT01306864
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- Bleeding peptic ulcer
- Patient is: < 18 years of age
- Patient is unable to consent
- Patient is contraindicated to undergo endoscopy
- Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
- Patient is pregnant or lactating
- Patinet has an INR > 2.5
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hemospray Treatment Hemospray Kit Hemospray Kit
- Primary Outcome Measures
Name Time Method Proportion of patients with further bleed 72 Hours
- Secondary Outcome Measures
Name Time Method Proportion of patients with initial hemostasis At the conclusion of the index procedure
Trial Locations
- Locations (12)
Vancouver Coastal Health
🇨🇦Vancouver, British Columbia, Canada
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Bradford Teaching Hospital NHS Foundation
🇬🇧Bradford, United Kingdom
Erasmus MC University Medical Center
🇳🇱Rotterdam, Netherlands
Royal Alexandra
🇨🇦Edmonton, Alberta, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Health Science Centre University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
The Ottawa Hospital- Civic Campus and General Campus
🇨🇦Ottawa, Ontario, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
University of Nottingham
🇬🇧Nottingham, United Kingdom