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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
This device is used as a guidance for placing a brain catheter to target the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.
Average number of passes needed to place the catheter in each subject.
Measured by the number of passes needed to place the catheter. If the first attempt fails, another US sweep will be performed, and another attempt will be performed. If that fails, then the procedure will be aborted.
Time frame: 0 minutes
Post procedure imaging accuracy of the placement of the EVD will be performed by reviewing post procedure imaging using the Kakarla scoring system
Grade 1 means optimal placement in the ipsilateral frontal horn or third ventricle; Grade 2 means a functional placement in the contralateral lateral ventricle or no eloquent cortex; and Grade 3 means suboptimal placement in the eloquent cortex or nontarget cerebrospinal fluid space, with or without functional drainage
Time frame: up to 7 days
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