External Ventricular Drainage Post-Market Clinical Follow-up Registry

Last updated: January 2, 2025
Sponsor: Integra LifeSciences Corporation
Overall Status: Completed

Phase

N/A

Condition

Neurologic Disorders

Treatment

External Ventricular Drainage (EVD)

Clinical Study ID

NCT05652296
C-EXTVDR-001
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient and/or legally authorized representative has agreed to participate in thestudy 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 theIntegra or Codman External Ventricular Drainage System.

  3. For patients who have had the EVD System removed prior to study enrollment, haveavailable follow-up data from implant until the EVD System is no longer required fordrainage and monitoring of CSF.

Exclusion

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 becontraindicated per the IFU.

  5. The Patient is otherwise determined by the Investigator to be medically unsuitablefor participation in this Registry.

  6. The Patient is currently enrolled in another device trial or has been previouslyentered in this trial.

  7. The Patient is a prisoner or member of a different vulnerable population that shouldnot 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

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: External Ventricular Drainage (EVD)
Phase:
Study Start date:
March 03, 2023
Estimated Completion Date:
December 16, 2024

Study 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.

Connect with a study center

  • Ziekenhuis Oost-limburg

    Genk, 3600
    Belgium

    Site Not Available

  • University Hospitals leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8000
    Belgium

    Site Not Available

  • Hôpital Gui de Chauliac

    Montpellier, 34295
    France

    Site Not Available

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