NCT01556711

Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology

Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope® Ahead™ Technology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 816 (actual)
• Sponsor: BrainScope Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the study are to document device performance with respect to the primary and secondary endpoints.

Detailed description

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.

Conditions

• Brain Injuries
• Craniocerebral Trauma

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-03-16
• Last updated: 2013-12-10

Locations

11 sites across 1 country: United States