Trials / Completed
CompletedNCT02164201
Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (actual)
- Sponsor
- CryoLife Europa · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.
Conditions
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2014-06-16
- Last updated
- 2015-07-29
Locations
2 sites across 2 countries: Germany, Italy
Source: ClinicalTrials.gov record NCT02164201. Inclusion in this directory is not an endorsement.