Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
NCT ID: NCT05397106
Last Updated: 2026-01-14
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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RECRUITING
158 participants
OBSERVATIONAL
2023-01-24
2029-01-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CODMAN CERTAS Programmable Valves
CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.
CODMAN CERTAS Plus Programmable Valve
Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
Interventions
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CODMAN CERTAS Plus Programmable Valve
Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
Eligibility Criteria
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Inclusion Criteria
2. Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
3. Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements.
4. For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time.
Exclusion Criteria
2. Patient's planned shunt has distal drainage to the heart.
3. Patient has ventriculitis, peritonitis or meningitis.
4. Patient has sepsis.
5. Patient has a history of poor wound healing.
6. 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.
7. Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
8. Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
9. Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
10. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
11. 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.
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Sherese Fralin, MSN, FNP, PhD
Role: STUDY_DIRECTOR
Integra LifeSciences
Locations
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University Hospital Leuven
Leuven, , Belgium
AZ Delta - Roeselare
Roeselare, , Belgium
Klinikum Dortmund Wirbelsäulenchirurgie
Dortmund, , Germany
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
Düsseldorf, , 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
Countries
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Central Contacts
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Facility Contacts
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Dr. Oliver Müller
Role: primary
Dr. Philipp Dammann
Role: primary
Dr. Mukesch Johannes Shah
Role: primary
Dr. Oliver Gandslandt
Role: primary
Other Identifiers
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C-CERTAS-002
Identifier Type: -
Identifier Source: org_study_id
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