Post-market Assessment of Biodesign Dural Repair Grafts

Completed

• Conditions: Cerebrospinal Fluid Leak

• Registration Number: NCT04057157
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Study Start: 2019-09-03
• Primary Completion: 2022-06-06
• Study Completion: 2022-09-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (3)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

University of Alabama Birmingham Hospital; 🇺🇸 Birmingham, Alabama, United States

Ospedale Bellaria-Bolonga; 🇮🇹 Bologna, Italy