Angiodysplasia, Colonic Diverticula, Colonic Polyp
Conditions
Keywords
Gastriointestinal, Lower gastriointestinal, Digestive, Hemostasis, Recurrent bleeding, Hemospray
Brief summary
This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.
Interventions
DEVICEHemospray
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.
Sponsors
Cook Group Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis
Exclusion criteria
* Less than 19 years old * 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 Medical/Endoscopic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of device related adverse events | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of recurrent bleeding that occurs outside the blood vessel | 30 days | — |
| Percentage of hemostasis of lower GI bleeds originating from multiple sources | 30 days | — |
| All cause mortality | 30 days | Mortality within 30 days of index procedure |
Countries
Canada
Outcome results
None listed