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.
- HS-1000 Device
ARM 1: Kind: Experimental Label: HS-1000 recording Description: ICP readings will be recorded in parallel from both the invasive ICP monitor, and HeadSense's non-invasive ICP monitor. Each recording session will be done until an aggregate of at least 30 minutes worth of quality data is collected, depending on the patient's clinical condition. For each patient, two recording sessions will be completed for 30-60 minutes each for 120 minutes total.
- Masking: Open Label
- Purpose: Diagnostic
- Intervention: Single Group Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Number of ICP values obtained by the HS device that correlate to ICP using current standards||30 minutes||No|
|Secondary||Incidence of adverse events during and after recording sessions||96 hours||Yes|
- HeadSense Medical Lead