Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Launched by INTEGRA LIFESCIENCES CORPORATION · May 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the CODMAN CERTAS Plus Programmable Valve, a device used to help manage conditions like hydrocephalus (which is an accumulation of fluid in the brain), normal pressure hydrocephalus, and other related conditions. The trial is currently recruiting participants of all ages who either have had this valve implanted in the past or are planning to have it implanted in the future. To take part, individuals or their legal representatives must agree to the study and be willing to follow the required procedures and timelines.

If you or a loved one are considering joining this study, you'll need to meet certain criteria. For example, you should be planning to have surgery that involves this valve, or you should have had it implanted already, with data available since the implant. However, there are some reasons you might not be able to participate, such as having certain infections or recent surgeries, or if you are currently involved in another clinical trial. If you join, you can expect to be monitored closely to gather important information about the valve's performance over time.

Gender

ALL

Eligibility criteria

• 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.