External Ventricular Drainage Post-Market Clinical Follow-up Registry

Integra LifeSciences

Status: Completed

Conditions: Cerebrospinal; Disorder

Treatments: Device: External Ventricular Drainage (EVD)

Study type: Observational

Funder types: Industry

Identifiers

NCT05652296

C-EXTVDR-001

Details and patient eligibility

About

This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.

Full description

The purpose of this study is to investigate whether the Integra External Ventricular Drainage System listed as part of this study do perform to clinical expectations.

Additionally, this study will focus on the safety of these devices by collecting any device-specific Adverse Events (AEs) or Device deficiencies (DDs) seen when used during standard of care procedures.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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 design