Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

NCT03353246 | Completed Results FDA Device

• 1 other identifier: Pro00087011
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Head Trauma; Craniocerebral Injuries; Crushing Skull Injury; Head Injuries; Head Injuries, Multiple; Head Injuries, Closed; Head Trauma,Closed; Head Trauma Injury; Head Trauma, Penetrating; Head Injury, Minor; Head Injury Major; Head Injury, Open; Injuries, Craniocerebral; Injuries, Head; Multiple Head Injury; Trauma, Head

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level

  Up to 30 days after first CT scan

• Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level

  Up to 30 days after first CT scan

• Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level

  Up to 30 days after first CT scan

• False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level

  Up to 30 days after first CT scan

• Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level

  Up to 30 days after first CT scan

Study Arms (1)

InfraScanner 2000™

EXPERIMENTAL

All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.

Device: InfraScanner 2000™

Interventions

InfraScanner 2000™ DEVICE

The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.

InfraScanner 2000™

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient who presents to Duke University Hospital with suspected head trauma and receives a brain CT scan will be considered for this study.

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Head Injuries, Closed; Head Injuries, Penetrating

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Wounds, Penetrating

Results Point of Contact

• Title: Michael Haglund, M.D., Ph.D.
• Organization: Duke University Medical Center

haglu001@mc.duke.edu

919-684-6936

Study Officials

• Michael Haglund, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: December 11, 2017
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: August 20, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)