External Ventricular Drainage Post-Market Clinical Follow-up Registry

Completed

• Conditions: Cerebrospinal; Disorder

• Registration Number: NCT05652296
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-15
• Study Start: 2023-03-03
• Primary Completion: 2024-12-16
• Study Completion: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anticipated drainage of cerebrospinal fluid (CSF)	Through study completion, an average of 2 years	Percentage of subjects with anticipated drainage (i.e., observed drainage consistent with the patient's clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer required.

Secondary Outcome Measures

Name	Time	Method
Success of the access to the intracranial space	Through study completion, an average of 2 years	Percentage of subjects in whom the CODMAN Cranial Access Kit, when used with appropriate accessories, provided successful access to the intracranial space.

Trial Locations

Locations (4)

Ziekenhuis Oost-limburg; 🇧🇪 Genk, Belgium

University Hospitals leuven; 🇧🇪 Leuven, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France