External Ventricular Drainage Post-Market Clinical Follow-up Registry

NCT05652296 | Completed Results

• 1 other identifier: C-EXTVDR-001
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 4

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.

Conditions

Cerebrospinal; Disorder

Outcome Measures

Primary Outcomes (1)

• Anticipated Drainage of Cerebrospinal Fluid (CSF)

  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.

  1 month following device implantation

Secondary Outcomes (1)

• Success of the Access to the Intracranial Space

  1 month following device implantation

Other Outcomes (2)

• Device- or Procedure Related Adverse Events (AEs) During the Use of the Device in the Patient

  1 month following device implantation

• Noted Device Deficiencies During Use of the Device Such as Malfunction, Use Errors, or Other Issues Related to the Performance or Safety of the External Ventricular Drainage Systems and Accessories

  1 month following device implantation

Interventions

External Ventricular Drainage (EVD) DEVICE

EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients of any age, and gender who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories

You may qualify if:

• Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
• Patients (of any age) who underwent or who plan to have a procedure with one of the Integra or Codman External Ventricular Drainage System.
• 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.

You may not qualify if:

• The Patients in whom more than one EVD System were or are intended to be placed.
• The Patient has sepsis.
• The Patient has a history of poor wound healing.
• The patient exhibits signs of scalp infection prior to implantation that would be contraindicated per the IFU.
• The Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
• The Patient is currently enrolled in another device trial or has been previously entered in this trial.
• The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
• The Patients known to have uncorrected coagulopathy.
• The Patients with known hypersensitivity to rifampin or clindamycin hydrochloride (prior to implantation of Bactiseal catheters)

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (4)

Ziekenhuis Oost-limburg

Genk, 3600, Belgium

Location

University Hospitals leuven

Leuven, 3000, Belgium

Location

AZ Delta

Roeselare, 8000, Belgium

Location

Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Results Point of Contact

• Title: Andrew Tummon
• Organization: Integra LifeSciences

andrew.tummon@integralife.com

+1 (609) 936-5490

Study Officials

• Jason Marzuola

  Integra LifeSciences Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: March 3, 2023
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Locations

BE (3); FR (1)