Brain Injuries, Traumatic Clinical Trial
Official title:
Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.
MOBI-1 is a single-arm, multi-center derivation / validation study that will evaluate the use of the Infrascanner for monitoring traumatic intracranial hematomas. All patients will receive standard care plus hourly infrascanner assessments. This study will test the hypotheses that: 1. The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas 2. Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone 3. Clinical / research staff will be able to attain all data points and relay the assessments to the medical team. ;
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