N/A
Completed N=500
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Head Trauma · Craniocerebral Injuries · Crushing Skull Injury · Head Injuries
Source: ClinicalTrials.gov NCT03353246 ↗
Enrolled (actual)
500
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level — 85.6 percentage
Summary
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Duke University Hospital (DUH) who have sustained or who are suspected to have sustained head trauma and have consequently received a brain computed tomography (CT) scan(s).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level |
85.6 | — |
| PRIMARY Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level |
88.5 | — |
| PRIMARY Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level |
95.7 | — |
| PRIMARY Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level |
95.5 | — |
| PRIMARY False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level |
16.0 | — |
| PRIMARY False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level |
10.1 | — |
| PRIMARY False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level |
3.8 | — |
| PRIMARY False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level |
5.2 | — |
| SECONDARY Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level |
94.2 | — |
| SECONDARY Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level |
95.7 | — |
| SECONDARY Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level |
100.0; 96.9; 75.0; 100.0 | — |
| SECONDARY False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level |
0.0; 0.5; 0.8; 0.0 | — |
| SECONDARY Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level |
90.9; 98.3; 88.0; 96.2 | — |
| SECONDARY False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level |
0.3; 0.5; 0.8; 0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Any patient who presents to Duke University Hospital with suspected head trauma and receives a brain CT scan will be considered for this study.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT03353246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.