Presence of High Intracranial Pressure Clinical Trial
Official title:
A Prospective, Open-Label, Non-Randomized, Comparative Study Designed to Evaluate the Accuracy and Safety of HS-1000 Device, a Non-Invasive Intracranial Pressure (ICP) Monitor, in Patients Undergoing Invasive ICP Monitoring Procedure for Various Clinical Conditions
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks.
HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's
head. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and
accurately monitor ICP with minimal discomfort to patients, and provide information about
normal or elevated ICP levels to the physicians.
The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive
ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)
HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening