Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
Sponsored by Integra LifeSciences Corporation
About this trial
Last updated 2 years ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Patient requires a surgical procedure to implant (de novo) a shunt for the treatment of hydrocephalus utilizing CODMAN CERTAS Plus Programmable Valve according to it intended use.
2. Patient (legally designated representative) has completed the Informed Consent process prior to enrollment into this study.
3. Patient (legally designated representative) is willing to comply with the study protocol timelines & requirements.
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