Trials / Completed
CompletedNCT02099435
Study of Hemospray for Lower Gastrointestinal Hemorrhage
A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Cook Group Incorporated · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2016-11-06
- Completion
- 2016-11-06
- First posted
- 2014-03-28
- Last updated
- 2017-01-20
Locations
4 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT02099435. Inclusion in this directory is not an endorsement.