Stroke Clinical Trial
Official title:
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
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 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.
A prospective study will be conducted on 80 patients with an inserted invasive
intraparenchymal ICP monitor. Once a patient undergoes invasive ICP monitoring, has a life
expectancy of greater than 48 hours and is 14 years old and over at the screening visit, and
has an intact/continuous dura layer, the patient will become a candidate for enrollment into
the study. If the patient signs the informed consent or the patient's legal authorized
representative signs on the patient's behalf, the patient will be enrolled into the trial.
Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the
HeadSense's device. Once the data collection is complete, results will be analyzed by
comparing ICP readings from both devices.
The primary end-point of the study is to collect 60-120 minutes of ICP monitoring data over
two sessions of 30-60 minutes each for 80 neurosurgery patients of any etiology. The
secondary endpoint of this study is evaluate the safety of the device as measured by
incidence of adverse events and serious adverse events over each subject's 96 hours of
participation.
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