NCT01306864CompletedNot Applicable
Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding
Cook Group Incorporated12 sites in 4 countries67 target enrollmentStarted: December 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cook Group Incorporated
- Enrollment
- 67
- Locations
- 12
- Primary Endpoint
- Proportion of patients with further bleed
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bleeding peptic ulcer
Exclusion Criteria
- •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
Arms & Interventions
Hemospray Treatment
Experimental
Hemospray Kit
Intervention: Hemospray Kit (Device)
Outcomes
Primary Outcomes
Proportion of patients with further bleed
Time Frame: 72 Hours
Secondary Outcomes
- Proportion of patients with initial hemostasis(At the conclusion of the index procedure)
Investigators
Study Sites (12)
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