Post-market Assessment of Biodesign Dural Repair Grafts

Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04057157

Enrollment

128

Registered

2019-08-15

Start date

2019-09-03

Completion date

2022-09-15

Last updated

2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrospinal Fluid Leak

Keywords

dura mater repair, cerebrospinal fluid leak, CSF leak, Biodesign® Dural Repair Graft, Biodesign® Duraplasty Repair Graft

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.

Interventions

DEVICEBiodesign Dural or Duraplasty Repair Grafts

Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage	2 months	Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis).

Countries

Canada, Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026