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Post-market Assessment of Biodesign Dural Repair Grafts

NCT04057157 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2022-10-14

No results posted yet for this study

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.

Conditions

  • Cerebrospinal Fluid Leak

Interventions

DEVICE

Biodesign Dural or Duraplasty Repair Grafts

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

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2022-06-06
Completion
2022-09-15

Countries

  • United States
  • Canada
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057157 on ClinicalTrials.gov