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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.
The clinical investigation specifically aims to collect data on the performance measures outlined below. Data will be collected per standard of care, given the nature of the clinical investigation to capture real world data (registry); timing, frequency, and methodology of assessing the performance outcomes may therefore differ per center, subject, and/or visit.
1) Improvement of the following symptoms related to hydrocephalus:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CODMAN CERTAS Programmable Valves | CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CODMAN CERTAS Programmable Valves | Device | Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance Endpoints | The change from baseline for the following symptoms related to hydrocephalus, e.g. gait disturbances, spatial impairment, cognitive abilities, urinary incontinence, pain caused by headaches and visual acuity. | 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Deficiencies | Incidence and nature of device deficiencies | 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints: Incidence and nature of adverse device effects | Incidence and nature of adverse device effects | 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months |
Inclusion Criteria:
Exclusion Criteria:
N/A
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Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.
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| Name | Affiliation | Role |
|---|---|---|
| Sanja Ilic, MD | Integra LifeSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany | ||||
| UniversitätsKlinikum Essen |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 28, 2023 | |
| Reset | Dec 1, 2023 | |
| Release | Dec 15, 2023 | |
| Reset | May 30, 2024 | |
| Release | Jun 12, 2024 | |
| Reset | Sep 27, 2024 | |
| Release | Nov 20, 2024 | |
| Reset | Jan 7, 2025 | |
| Release | Jan 8, 2025 | |
| Reset | Jan 29, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 28, 2023 | Dec 1, 2023 | |||
| Dec 15, 2023 |
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D006850 | Hydrocephalus, Normal Pressure |
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019586 | Intracranial Hypertension |
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| Essen |
| Germany |
| Freiburg University Hospital | Freiburg im Breisgau | Germany |
| Universitätsmedizin Mannheim | Mannheim | Germany |
| Klinikum rechts der Isar Technischen Universitat München | München | 81675 | Germany |
| München Klinik Bogenhausen | München | Germany |
| Klinikum der LandesHauptStadt Stuttgart gKAôR | Stuttgart | Germany |
| Erasmus University Medical Center | Rotterdam | Netherlands |
| May 30, 2024 |
| Jun 12, 2024 | Sep 27, 2024 |
| Nov 20, 2024 | Jan 7, 2025 |
| Jan 8, 2025 | Jan 29, 2025 |