Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding

Cook Group Incorporated67 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bleeding Peptic Ulcers

Interventions

Hemospray KitDEVICE

Hemostasis of Arterial GI Bleeding

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Royal Alexandra

Edmonton, Alberta, Canada

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Health Science Centre University of Manitoba

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Proportion of patients with further bleed

Time frame: 72 Hours

Secondary Outcomes

Proportion of patients with initial hemostasis

Time frame: At the conclusion of the index procedure

Data from ClinicalTrials.gov

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