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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 valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.
This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.
Data collection for each patient will occur per standard of care.
However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.
Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.
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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 Plus Programmable Valve | Device | Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment | Device Success is defined as:
| 30 Days |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Valve Replacement | Incidence of Valve replacement post - implantation | 12, 24 and 36 Months |
| Adverse Events | Incidence of Adverse Events post - implantation Long term safety will be assessed by the incidence of all adverse events/complications including number of subjects with shunt and/or shunt system infections. |
Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients of any age, gender, and ethnicity, with hydrocephalus.
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 |
|---|---|---|
| Sherese Fralin, MSN, FNP, PhD | Integra LifeSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Leuven | Belgium | ||||
| AZ Delta - Roeselare |
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| 12, 24 and 36 Months |
| Number of encounters with inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves | Incidence of inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves post - implantation prior to MRI | 12, 24 and 36 Months |
| Roeselare |
| Belgium |
| Klinikum Dortmund Wirbelsäulenchirurgie | Dortmund | Germany |
| Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| Freiburg University Hospital | Freiburg im Breisgau | Germany |
| Katharinenhospital - Neurochirurgische Klinik Stuttgart | Stuttgart | Germany |
| Hospital12 de Octubre | Madrid | Spain |
| Canton Hospital St. Gallen | Sankt Gallen | Switzerland |
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D006850 | Hydrocephalus, Normal Pressure |
| D011559 | Pseudotumor Cerebri |
| D001932 | Brain Neoplasms |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019586 | Intracranial Hypertension |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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