N/A
Completed N=117
External Ventricular Drainage Post-Market Clinical Follow-up Registry
Cerebrospinal; Disorder
Source: ClinicalTrials.gov NCT05652296 ↗
Enrolled (actual)
117
Serious AEs
50.4%
Results posted
Jan 2026
Primary outcomePrimary: Anticipated Drainage of Cerebrospinal Fluid (CSF) — 116 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anticipated Drainage of Cerebrospinal Fluid (CSF) |
116 | — |
| SECONDARY Success of the Access to the Intracranial Space |
— | — |
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)
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. Informational only — not medical advice.