Status:
RECRUITING
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Hydrocephalus
Hydrocephalus in Children
Eligibility:
All Genders
Brief Summary
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
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 pe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
- Patient's planned shunt has distal drainage to the heart.
- Patient has ventriculitis, peritonitis or meningitis.
- Patient has sepsis.
- Patient has a history of poor wound healing.
- 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.
- Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
- Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
- Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
- Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
- 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.
Key Trial Info
Start Date :
January 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05397106
Start Date
January 24 2023
End Date
September 30 2027
Last Update
November 20 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Leuven
Leuven, Belgium
2
AZ Delta - Roeselare
Roeselare, Belgium
3
Klinikum Dortmund Wirbelsäulenchirurgie
Dortmund, Germany
4
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
Düsseldorf, Germany, 40225