Brain Injuries Clinical Trial
Official title:
Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope® Ahead™ Technology
The objectives of the study are to document device performance with respect to the primary and secondary endpoints.
The purpose of the current study is proposed to prospectively validate the BrainScope Ahead®
M-100 device design, performance, and labeling with respect to the device's target intended
use and indications for use:
- Primary Endpoint:
- Structural Injury Assessment
- There are four co-primary endpoints in this study: two sets of sensitivity and
specificity to divide the data into three classes.
- Using a BrainScope classification algorithm, the Ahead® M100 will identify
subjects showing sensitivities among 3 classes: Green-normal, nonhead injured
controls,Yellow-head injured subjects who do not exhibit brain electrical activity
that is consistent with a structural brain injury observable on CT or for whom CT
was not deemed necessary,Red-head injured subjects who exhibit brain electrical
activity consistent with a structural brain injury observable by CT.
- Secondary Endpoint:
- Functional Injury Assessment
- There are two co-secondary endpoints for the secondary objective, the sensitivity
and specificity to split Yellow from the primary endpoint into two sub groups
depending on degree of brain functional impairment observable by an evaluation of
the clinical findings on a clinical charter used as the assessment of truth.
;
Observational Model: Case Control, Time Perspective: Prospective
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