Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve
Status: Active_not_recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
• Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
• Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements.
• 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.
Locations
Other Locations
Belgium
University Hospital Leuven
Leuven
AZ Delta - Roeselare
Roeselare
Germany
Klinikum Dortmund Wirbelsäulenchirurgie
Dortmund
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
Düsseldorf
Universitätsklinikum Essen
Essen
Freiburg University Hospital
Freiburg Im Breisgau
Katharinenhospital - Neurochirurgische Klinik Stuttgart
Stuttgart
Spain
Hospital12 de Octubre
Madrid
Switzerland
Canton Hospital St. Gallen
Sankt Gallen
Time Frame
Start Date: 2023-01-24
Completion Date: 2029-01-24
Participants
Target number of participants: 160
Treatments
CODMAN CERTAS Programmable Valves
CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.
Related Therapeutic Areas
Sponsors
Leads: Integra LifeSciences Corporation