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OpenTrials
Completed

NCT Number: NCT04057157

Post-market Assessment of Biodesign Dural Repair Grafts

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.

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Key information

Conditions

Cerebrospinal Fluid Leak Cerebrospinal Fluid Otorrhea Craniocerebral Trauma Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Planned use of the Biodesign Dural or Duraplasty Graft.

Exclusion criteria

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

Treatment and study plan

Biodesign Dural or Duraplasty Repair Grafts

Device

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

Primary outcomes

  1. Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2019
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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