Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve
Status: 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
RECRUITING
Leuven
AZ Delta - Roeselare
RECRUITING
Roeselare
Germany
Klinikum Dortmund Wirbelsäulenchirurgie
RECRUITING
Dortmund
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
RECRUITING
Düsseldorf
Universitätsklinikum Essen
RECRUITING
Essen
Freiburg University Hospital
RECRUITING
Freiburg Im Breisgau
Katharinenhospital - Neurochirurgische Klinik Stuttgart
RECRUITING
Stuttgart
Spain
Hospital12 de Octubre
NOT_YET_RECRUITING
Madrid
Switzerland
Canton Hospital St. Gallen
RECRUITING
Sankt Gallen
Contact Information
Primary
Maria Salmon-Sargeant
maria.salmonsargeant@integralife.com
339-206-2979
Backup
Andrew Tummon
Andrew.Tummon@integralife.com
1-609-936-5490
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 158
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