PMCF of CODMAN CERTAS Programmable Valve
Study Details
Study Description
Brief Summary
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CODMAN CERTAS Programmable Valves CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve. |
Device: CODMAN CERTAS Plus Programmable Valve
Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
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Outcome Measures
Primary Outcome Measures
- CODMAN CERTAS Plus Programmable Valve implant procedure success [(<48 hours)]
Procedural Success is defined as: Device implanted as originally intended, and No device or procedure related serious adverse events (SAEs) (Life threatening bleed; major neuro, vascular or cardiac structural complications requiring unplanned reintervention or surgery; mechanical circulatory support or prolonged intubation
- Technical success -Time Frame: Procedure Stop Time [(<48 hours)]
Technical Success is defined as: Alive, with Deployment with correct valve positioning, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
- Device success [30 Days]
Device Success is defined as: Alive, with Original intended device in place, and No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from operating room (OR)), and intended performance of the device.
Other Outcome Measures
- Incidence of Valve Replacement [12, 24 and 36 Months]
Incidence of Valve replacement post - implantation
- Adverse Events [12, 24 and 36 Months]
Incidence of Adverse Events post - implantation
- Number of encounters with inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves [12, 24 and 36 Months]
Incidence of inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves post - implantation following MRI
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient requires a surgical procedure to implant (de novo) a shunt for the treatment of hydrocephalus utilizing CODMAN CERTAS Plus Programmable Valve according to it intended use.
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Patient (legally designated representative) has completed the Informed Consent process prior to enrollment into this study.
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Patient (legally designated representative) is willing to comply with the study protocol timelines & requirements.
Exclusion Criteria:
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Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
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Patient's planned shunt has distal drainage to the heart.
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Patient has ventriculitis, peritonitis or meningitis.
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Patient has sepsis.
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Patient has a history of poor wound healing.
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Patient has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this study.
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Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant
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Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
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Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
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Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or IRB/ethics committee.
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Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the BACTISEAL Catheters (included in some models of the valve) only
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum Dortmund Wirbelsäulenchirurgie | Dortmund | Germany | ||
| 2 | Universitätsklinikum Essen | Essen | Germany | ||
| 3 | Freiburg University Hospital | Freiburg | Germany | ||
| 4 | Katharinenhospital - Neurochirurgische Klinik Stuttgart | Stuttgart | Germany |
Sponsors and Collaborators
- Integra LifeSciences Corporation
Investigators
- Study Director: Sanja Ilic, MD, Integra LifeSciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C-CERTAS-002