CODMAN CERTAS Plus Programmable Valve: Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
Study summary
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
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:
1. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
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.
Primary outcome measure(s)
Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment — 30 Days Device Success is defined as:
1. Deployment with the correct valve positioning
2. Original intended device in place, and
3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure.
Trial sites (9)
Facility
City
Region
Status
University Hospital Leuven
Leuven
Belgium
AZ Delta - Roeselare
Roeselare
Belgium
Klinikum Dortmund Wirbelsäulenchirurgie
Dortmund
Germany
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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