Post-market Assessment of Biodesign Dural Repair Grafts

Completed

Conditions studied: Cerebrospinal Fluid Leak

In brief

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.

Key facts

Study ID

NCT04057157

Run by

Cook Research Incorporated

People needed

128

Starts

2019-09-03

Expected to finish

2022-09-15

Last updated by the study team

2022-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planned use of the Biodesign Dural or Duraplasty Graft.

You may not qualify if…

• Age <18 years
• Unable or unwilling to provide informed consent
• Life expectancy <6 months

Where it is running

• University of Alabama Birmingham Hospital — Birmingham, Alabama, United States
• Toronto Western Hospital — Toronto, Ontario, Canada
• Ospedale Bellaria-Bolonga — Bologna, Italy

Full record on ClinicalTrials.gov

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