NCT06253858NARecruiting
Ultrasound (US) Guided External Ventricular Catheter Placement
Milton S. Hershey Medical Center
Start Date
4/1/2026
Completion Date
12/1/2026
Summary
To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Decision made to perform the procedure by the primary consultant
* Age 18 or older
* Neuro ICU stay
* Newly diagnosed hydrocephalus
* Has a recent CT within the past 24 hrs
* Normal platelets and coagulation profile
* No active infection or currently on antibiotics
* The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging
Exclusion Criteria:
* Age \<18
* Not in Neuro ICU setting
* Previous placement of a ventricular catheter
* More than 50 percent of the fluid compartment is filled with blood by CT scan
* Time to include in the trial prohibited by clinical personnel
Interventions
DEVICE
Catheter Placement with Solopass System
Conditions
Hydrocephalus
Locations
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States