N/A
N=117
External Ventricular Drainage Post-Market Clinical Follow-up Registry
Cerebrospinal; Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05652296 ↗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
| Outcome | Result | p-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)
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.