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N/A N=117

External Ventricular Drainage Post-Market Clinical Follow-up Registry

Cerebrospinal; Disorder

Enrolled (actual)
117
Serious AEs
50.4%
Results posted
Jan 2026
Primary outcome: Primary: Anticipated Drainage of Cerebrospinal Fluid (CSF) — 116 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
External Ventricular Drainage (EVD) (Device)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Integra LifeSciences Corporation
Primary completion
Dec 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Anticipated Drainage of Cerebrospinal Fluid (CSF)
116
SECONDARY
Success of the Access to the Intracranial Space

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 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05652296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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