Trials / Unknown
UnknownNCT01879475
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
Prospective, Randomised, Controlled Investigation Comparing the Safety and Performance of 032-11 Surgical Haemostat With FLOSEAL® Haemostatic Matrix in Cardiac Surgery and Thoracic Aortic Surgery.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Medtrade · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 032-11 | Topical haemostat |
| DEVICE | Floseal (R) | Topical haemostat |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2015-10-01
- First posted
- 2013-06-17
- Last updated
- 2015-04-07
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01879475. Inclusion in this directory is not an endorsement.