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Clinical Trials in Germany / NCT05397106
Active, not recruiting Observational

Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

NCT05397106 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2023-01-24
Last updated
2026-02-27

Condition(s) studied

HydrocephalusHydrocephalus in ChildrenNPH (Normal Pressure Hydrocephalus)IIH - Idiopathic Intracranial HypertensionBrain TumorPost-Traumatic HydrocephalusHemorrhagic Stroke

Investigational drug(s) / intervention(s)

CODMAN CERTAS Plus Programmable Valve

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)

Trial sites (9)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05397106 on ClinicalTrials.gov ↗ ← All trials in Germany