Post-market Assessment of Biodesign Dural Repair Grafts

Cook Group

Status: Completed

Conditions: Cerebrospinal Fluid Leak

Treatments: Device: Biodesign Dural or Duraplasty Repair Grafts

Study type: Observational

Funder types: Industry

Identifiers

NCT04057157

17-10

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Planned use of the Biodesign Dural or Duraplasty Graft.

Exclusion criteria

1. Age <18 years
2. Unable or unwilling to provide informed consent
3. Life expectancy <6 months