Status:
COMPLETED
Post-market Assessment of Biodesign Dural Repair Grafts
Lead Sponsor:
Cook Research Incorporated
Conditions:
Cerebrospinal Fluid Leak
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
Eligibility Criteria
Inclusion
- 1\. Planned use of the Biodesign Dural or Duraplasty Graft.
Exclusion
- Age \<18 years
- Unable or unwilling to provide informed consent
- Life expectancy \<6 months
Key Trial Info
Start Date :
September 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04057157
Start Date
September 3 2019
End Date
September 15 2022
Last Update
October 14 2022
Active Locations (3)
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1
University of Alabama Birmingham Hospital
Birmingham, Alabama, United States, 35294
2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
3
Ospedale Bellaria-Bolonga
Bologna, Italy, 40139