N/A
N=100
Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
Dura Mater Nick Cut or Tear · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02225080 ↗Enrolled (actual)
100
Serious AEs
31.0%
Results posted
Aug 2018
Primary outcome: Primary: Patient's Outcome — 73; 7; 15; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient's Outcome |
73; 7; 15; 3; 2 | — |
| SECONDARY Occurence of Adverse Event |
15 | — |
| SECONDARY Occurence of Adverse Event |
15 | — |
| SECONDARY Occurence of Adverse Event |
15 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
Exclusion Criteria
- Patient who does not agree to allow collection of his/her medical data
Data sourced from ClinicalTrials.gov (NCT02225080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.