Post-market Assessment of Biodesign Dural Repair Grafts

NCT ID: NCT04057157

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-03

Study Completion Date

2022-09-15

Brief Summary

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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

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Conditions

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Cerebrospinal Fluid Leak

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biodesign Dural or Duraplasty Repair Grafts

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

Site Status

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Ospedale Bellaria-Bolonga

Bologna, , Italy

Site Status

Countries

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United States Canada Italy

Other Identifiers

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17-10

Identifier Type: -

Identifier Source: org_study_id

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