Head Trauma Clinical Trial
Official title:
Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2000™) in Detecting Subdural and Epidural Hematomas in Patients Admitted to Duke University Hospital: A Pilot Study
Verified date | April 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 500 |
Est. completion date | May 4, 2018 |
Est. primary completion date | May 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level | Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Primary | Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level | Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Primary | Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Primary | Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Primary | False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Primary | False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Primary | False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Primary | False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Secondary | Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level | Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Secondary | Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level | Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Secondary | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Secondary | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Secondary | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan | |
Secondary | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM. | Up to 30 days after first CT scan |
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