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Completed

NCT Number: NCT04923867

Suturable DuraGen™ PMCF Study

The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.

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Key information

Conditions

Cerebrospinal Fluid Leak 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–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is between 18 and 80 years of age
  • Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
  • Availability of post-operative assessment results.

Exclusion criteria

  • There are no exclusionary criteria for this study population

Treatment and study plan

Suturable DuraGen™

Device

Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.

Primary outcomes

  1. Patient Outcome

    Time frame: post-up to 90 days

    Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure

Secondary outcomes

  1. Occurrence of Adverse Event

    Time frame: Between days 30-90

    Adverse event that occurred between days 30-90 post-operatively

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2021
Registry last updated
Apr 6, 2025

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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