Trials / Completed
CompletedNCT02225080
Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.
Conditions
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2014-08-25
- Last updated
- 2018-10-09
- Results posted
- 2018-08-16
Locations
5 sites across 4 countries: France, Germany, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02225080. Inclusion in this directory is not an endorsement.