At a glance
ClinicalIndex Comparison RecordN/ACompleted· 100 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 1
- ✓Patients who have undergone neurosurgery with DuraGen® Secure implantation
Key exclusion· 1
- ✕Unwillingness to allow collection of medical data
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
In Brief
An observational study for Dura Mater Nick Cut or Tear and Surgery. Completed, enrolled 100 participants across 5 sites in 4 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDura Mater Nick Cut or Tear, Surgery
CountriesFrance, Germany, Spain, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartOct 2014
Primary CompletionJun 2016
TodayJul 2026
First PostedAug 25, 2014
Enrollment StartOct 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.9 years ago