Brain Injuries Clinical Trial
Official title:
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal
pressure transducer or external ventricular drain (EVD), provides an ICP waveform that
encapsulates valuable diagnostic and monitoring clinical information.
HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP
waveform safely and accurately with minimal discomfort to patients, compared to standard
invasive ICP monitoring procedures used at the participating institutions.
A study will be conducted on 100 patients who undergo invasive ICP measurement due to suspected ICP elevation, regardless to etiology. Each enrolled patient will be monitored with the HS-1000 device and data will be collected throughout the entire procedure. Once the data collection is done, results of the non-invasive measurements will be analyzed accordingly. The end-point of the study is to collect at least half an hour of measurements for each participant. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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