Study Results
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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COMPLETED
106 participants
OBSERVATIONAL
2021-04-28
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Supratentorial Procedure Group
Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™.
Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
Infratentorial Procedure Group
Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™.
Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
Spinal Procedure Group
Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™.
Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
Interventions
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Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
Eligibility Criteria
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Inclusion Criteria
2. Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
3. Availability of post-operative assessment results.
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Tummon
Role: STUDY_DIRECTOR
Integra LifeSciences
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Baptist Medical Center
Jacksonville, Florida, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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Other Identifiers
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C-DGSUT-001
Identifier Type: -
Identifier Source: org_study_id
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