Phase
Condition
Brain Tumor
Blood Clots
Stroke
Treatment
CODMAN CERTAS Plus Programmable Valve
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient and/or legally authorized representative has agreed to participate in thestudy by signing the EC-approved consent form, where applicable.
Patients (of any age) who underwent or who plan to have a surgical procedureutilizing one of the Codman CERTAS Plus Programmable Valves.
Patient (legally designated representative) is willing to comply with the studyprotocol timelines & requirements.
For patients who have had the Codman CERTAS Plus Programmable Valve implanted priorto study enrollment, have available data from implantation to the current time.
Exclusion
Exclusion Criteria:
Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as arevision 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 anyincisions; an ear infection on either side; a respiratory tract infection; or aurinary tract infection that, in the Investigator's opinion is clinicallysignificant and might compromise the outcome of this study.
Patient has had any form of bowel surgery 30 days prior to device implant oranticipates bowel surgery within 90 days following device implant.
Patient is otherwise determined by the Investigator to be medically unsuitable forparticipation in this study.
Patient is currently enrolled in another drug or device trial or has been previouslyentered in this trial.
Patient is a prisoner or member of a different vulnerable population that should notbe included in the study per the investigator.
Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. Thiscriterion applies for patients to be treated with the BACTISEAL Catheters (includedin some models of the valve) only.
Study Design
Study Description
Connect with a study center
University Hospital Leuven
Leuven,
BelgiumActive - Recruiting
AZ Delta - Roeselare
Roeselare,
BelgiumActive - Recruiting
Klinikum Dortmund Wirbelsäulenchirurgie
Dortmund,
GermanyActive - Recruiting
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
Düsseldorf, 40225
GermanyActive - Recruiting
Universitätsklinikum Essen
Essen,
GermanyActive - Recruiting
Freiburg University Hospital
Freiburg,
GermanyActive - Recruiting
Katharinenhospital - Neurochirurgische Klinik Stuttgart
Stuttgart,
GermanyActive - Recruiting
Hospital12 de Octubre
Madrid,
SpainSite Not Available
Canton Hospital St. Gallen
St. Gallen,
SwitzerlandActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.