External Ventricular Drainage Post-Market Clinical Follow-up Registry

Launched by INTEGRA LIFESCIENCES CORPORATION · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on the safety and effectiveness of the Integra External Ventricular Drainage Systems, which are devices used to help manage fluid in the brain. The study aims to gather information about how well these systems work after they have already been used in patients. It is currently recruiting participants of all ages who have had or will have a procedure involving these drainage systems. To be eligible, participants or their legal representatives must agree to take part by signing a consent form. Additionally, patients should have follow-up data available if their drainage system was removed before joining the study.

If you decide to participate, you can expect to provide information about your experience with the drainage system, whether it was during the procedure or during follow-up care. This study is important because it helps researchers understand how these devices perform in real-life situations, which can improve care for future patients. However, some individuals may not be eligible to participate, including those with certain medical conditions or those currently taking part in another clinical trial. If you have any questions or concerns about your eligibility, it’s best to discuss them with your healthcare provider.

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 procedure with one of the Integra or Codman External Ventricular Drainage System.
• • 3. For patients who have had the EVD System removed prior to study enrollment, have available follow-up data from implant until the EVD System is no longer required for drainage and monitoring of CSF.
• Exclusion Criteria:
• • 1. The Patients in whom more than one EVD System were or are intended to be placed.
• • 2. The Patient has sepsis.
• • 3. The Patient has a history of poor wound healing.
• • 4. The patient exhibits signs of scalp infection prior to implantation that would be contraindicated per the IFU.
• • 5. The Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
• • 6. The Patient is currently enrolled in another device trial or has been previously entered in this trial.
• • 7. The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
• • 8. The Patients known to have uncorrected coagulopathy.
• • 9. The Patients with known hypersensitivity to rifampin or clindamycin hydrochloride (prior to implantation of Bactiseal catheters)

Trial Officials