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The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGenâ„¢.
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 DuraGenâ„¢ for a supratentorial, infratentorial, or spinal procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supratentorial Procedure Group | Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGenâ„¢. |
| |
| Infratentorial Procedure Group | Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGenâ„¢. |
| |
| Spinal Procedure Group | Subjects that have undergone a spinal procedure with the use of Suturable DuraGenâ„¢. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suturable DuraGenâ„¢ | Device | Suturable DuraGenâ„¢ Dural Regeneration Matrix, an absorbable implant for repair of dural defects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Outcome | Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure | post-up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Event | Adverse event that occurred between days 30-90 post-operatively | Between days 30-90 |
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Inclusion Criteria:
Exclusion Criteria:
1. There are no exclusionary criteria for this study population
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Neurosurgery service in Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Tummon | Integra LifeSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| Baptist Medical Center |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 28, 2025 | |
| Reset | Sep 15, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 28, 2025 | Sep 15, 2025 | |||
| Jul 6, 2026 |
| ID | Term |
|---|---|
| D065634 | Cerebrospinal Fluid Leak |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| Jacksonville |
| Florida |
| 32207 |
| United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |