A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT).
Study Type
OBSERVATIONAL
Enrollment
740
Suspected traumatic brain injury with head CT
Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative)
Cranial CT Intracranial Hemorrhage findings (positive/negative) and the binary Tbit™ System results (positive/negative) of each sample.
Time frame: within 12 hours from injury on day 0 of ED presentation
Tbit™ System sensitivity and specificity
Tbit™ System sensitivity and specificity relative to the standard-of-care (SOC)
Time frame: within 12 hours from injury on day 0 of ED presentation
Negative predictive value of the Tbit™ System
Negative predictive value of the Tbit™ System
Time frame: within 12 hours from injury on day 0 of ED presentation
Positive predictive value of the Tbit™ System
Positive predictive value of the Tbit™ System
Time frame: within 12 hours from injury on day 0 of ED presentation
Overall accuracy of the Tbit™ System
Overall accuracy of the Tbit™ System
Time frame: within 12 hours from injury on day 0 of ED presentation
Safety and adverse event profile
Safety and adverse event profile
Time frame: 6 months
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