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Completed

NCT Number: NCT05652296

External Ventricular Drainage Post-Market Clinical Follow-up Registry

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-limburg, Genk, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

External Ventricular Drainage (EVD)

Device

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

Primary outcomes

  1. Anticipated Drainage of Cerebrospinal Fluid (CSF)

    Time frame: 1 month following device implantation

    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 outcomes

  1. Success of the Access to the Intracranial Space

    Time frame: 1 month following device implantation

    Percentage of subjects in whom the CODMAN Cranial Access Kit, when used with appropriate accessories, provided successful access to the intracranial space.

Other outcomes

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

    Time frame: 1 month following device implantation

    Percentage of subjects with device related adverse events (AEs) during the use of the device in the patient

  2. 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

    Time frame: 1 month following device implantation

    Percentage of subjects with 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

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2022
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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