A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
Not Applicable
Completed
- Conditions
- Dural TearCerebrospinal Fluid Leak
- Interventions
- Device: Implantation of the ArtiFascia®Device: Implantation of other commercial suturable dural substitute
- First Posted Date
- 2019-10-30
- Last Posted Date
- 2022-11-10
- Lead Sponsor
- Nurami Medical Ltd
- Target Recruit Count
- 92
- Registration Number
- NCT04145544
- Locations
- 🇧🇪
Ziekenhuis Oost-Limburg, Genk, Belgium
🇨🇿St. Anne's University Hospital Brno, Brno, Czechia
🇨🇿Neurochirurgická klinika Přednosta FN Olomouc, Olomouc, Czechia
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