CompletedNot Applicable

External Ventricular Drainage Post-Market Clinical Follow-up Registry

Belgium, France120 participantsStarted 2023-03-03

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Anticipated Drainage of Cerebrospinal Fluid (CSF)

Timeframe: 1 month following device implantation

Trial details

NCT IDNCT05652296

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-16

Results submitted2025-12-17

View on ClinicalTrials.gov More Cerebrospinal; Disorder trials