Hydrocephalus Normal-Pressure Hydrocephalus (NPH)
Conditions
Interventions
None listed
Sponsors
Brainlab A.G.
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male and female, all age groups • Patient or legally authorized representative has signed the Informed Consent form • Ventricular catheter placement for the indications: o Elevated ICP o Enlarged ventricles o Disruption of the CSF drain of any origin o Ventricular catheter placement for the placement of reservoirs (e.g., Ommaya).
Exclusion criteria
Exclusion criteria: • Patients with slit ventricles (Frontal-Occipital Horn Width Ratio (FOHWR) 0.5) • Patients with preexisting catheter path at the same access • Exclusion criteria for MRI (e.g. pacemaker, recent prosthesis) judged by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The systematic investigation of prospective data obtained during clinical use of the EM Stylet will be performed by means of catheter placement evaluation on intraoperative or postoperative imaging (MRI or ultrasound). Catheter placement accuracy will be assessed based on following grading system adapted from Hayhurst et al. (Hayhurst et al., 2010): • Grade 1: Perforated catheter part is free floating in cerebrospinal fluid within the ventricle, approximately equidistant from ventricular walls, away from the choroid plexus and a straight trajectory from the burr hole. • Grade 2: Perforated catheter part is attached to a ventricular wall or involves choroid plexus • Grade 3: Perforated catheter part is partially or completely within the brain parenchyma or failed to cannulate the ventricle completely | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and Serious adverse events (all and device related) | — |
Countries
Netherlands
Outcome results
None listed