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This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemospray to treat lower GI bleeds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemospray | Device | The Hemosprayâ„¢ 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 Hemosprayâ„¢ material. Hemosprayâ„¢ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of device related adverse events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
Medical/Endoscopic Exclusion Criteria
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clinical sites
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta | Canada | |||
| University of Alberta Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30612959 | Derived | 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. |
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| ID | Term |
|---|---|
| D004241 | Diverticulum, Colon |
| D016888 | Angiodysplasia |
| D003111 | Colonic Polyps |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D004240 | Diverticulum |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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|
| All cause mortality |
Mortality within 30 days of index procedure |
| 30 days |
| Edmonton |
| Alberta |
| Canada |
| Hotel Dieu Hospital | Kingston | Ontario | Canada |
| Montreal General Hospital - McGill University | Montreal | Quebec | Canada |
| D004066 |
| Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D010335 | Pathologic Processes |