Study of Hemospray for Lower Gastrointestinal Hemorrhage
NCT ID: NCT02099435
Last Updated: 2017-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2015-01-31
2016-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hemospray to treat lower GI bleeds
Hemospray
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.
Interventions
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Hemospray
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unwilling or unable to sign and date the informed consent
* Pregnant, lactating or planning to become pregnant within 30 days of the procedure
* Contraindicated to undergo colonoscopy
* Actual or suspected lower GI perforation or fistula
* Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
* Actual or suspected ischemic colitis or infectious colitis
* Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified)
* Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)
19 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Hookey L, Barkun A, Sultanian R, Bailey R. Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy. Gastrointest Endosc. 2019 Apr;89(4):865-871. doi: 10.1016/j.gie.2018.10.029. Epub 2018 Oct 26.
Other Identifiers
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12-007
Identifier Type: -
Identifier Source: org_study_id
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