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Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

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ClinicalTrials.gov Identifier: NCT03353246
Recruitment Status : Completed
First Posted : November 27, 2017
Results First Posted : May 28, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE November 21, 2017
First Posted Date  ICMJE November 27, 2017
Results First Submitted Date  ICMJE May 3, 2019
Results First Posted Date  ICMJE May 28, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE December 11, 2017
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.
  • Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM.
  • Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM.
  • Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM.
  • False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.
  • False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.
  • False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.
  • False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Detection of hematomas [ Time Frame: Within 30 minutes of a head CT ]
    Determine whether the InfraScanner 2000™ detects epidural and/or subdural hematomas with adequate precision relative to CT scans to be used as a diagnostic tool for epidural and/or subdural hematomas.
  • Estimate sensitivity [ Time Frame: 6 months after enrollment completion ]
    Another primary objective of this study is to estimate the sensitivity of the portable NIR-based device (InfraScanner 2000™) in the identification of any size hematoma.
  • Estimate specificity [ Time Frame: 6 months after enrollment completion ]
    Another primary objective of this study is to estimate the specificity of the portable NIR-based device (InfraScanner 2000™) in the identification of any size hematoma.
  • Estimate false positives [ Time Frame: 6 months after enrollment completion ]
    Another primary objective of this study is to estimate false positives of the portable NIR-based device (InfraScanner 2000™) in the identification of any size hematoma.
  • Estimate false negatives [ Time Frame: 6 months after enrollment completion ]
    Another primary objective of this study is to estimate false negatives of the portable NIR-based device (InfraScanner 2000™) in the identification of any size hematoma.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM.
  • Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM.
  • Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.
  • False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.
  • Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.
  • False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Feasibility for future trial [ Time Frame: 4 months after enrollment completion ]
    Use these findings to inform the feasibility of conducting a future trial in which the InfraScanner 2000™ is used as a stand-alone diagnostic tool for intracranial hematomas, and therein, to determine candidacy for decompressive craniotomies in patients who suffer traumatic brain injuries in places where CT scans are not available.
  • Estimate test characteristics [ Time Frame: 6 months after enrollment completion ]
    A secondary objective is to estimate the test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume >3.5 mL and depth <2.5 cm) compared to CT scan results as the gold standard
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Official Title  ICMJE 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
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).
Detailed Description

When applicable (conscious patient and/or family or legally authorized representative is present) the study will be introduced to the patient and relevant parties prior to the research team approaching the patient. While head trauma frequently results in impaired cognition and/or consciousness, and due to the urgency of these circumstances patients are often not accompanied by kin, whenever appropriate, the purpose of the research and the procedure will be explained in detail with all questions answered to the patient's and/or representative's satisfaction. Because patients who sustain head trauma injuries typically remain within the hospital for multiple days for monitoring and care, each participant may undergo multiple CT scans over the course of his or her hospitalization, affording the opportunity to one to numerous measurements from each patient during his or her hospital stay.

Within 30 minutes following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image A). The procedure will entail placing 8 plastic light guides upon the patient's scalp. The study team member will use the device to sequentially emit light through each of the 8 light guides so that the light is incident upon scalp (Image B). The device is engineered such that the light emitter and receiver are spaced ~4cm apart, allowing the light's intensity to be measured between adjacent light guides (Image C). This entire procedure, including greeting the patient, placing the light guides, gathering the data, and removing the light guides should take ~10 minutes each time. The number of CT scans the patient receives determines the number of potential data collections. The patient will be approached by the study team following each CT scan to be scanned with the InfraScanner 2000™ (20). The patient and/or representative may refuse a scan during any encounter, and as such, the scan will not be done. For each patient scanned with the InfraScanner 2000™ they will be de-identified with a subject number, with age, sex, gender, skin color, hair color, hair thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT scan and near-infrared measurement. These data will be stored in de-identified form on Research Electronic Data Capture (REDCap) and/or Microsoft Excel 2016 on a secured DHTS server (S:\NSU_IRB\Pro00087011).

The collection period for each research subject concludes 30-days following his or her initial measurement with the InfraScanner 2000™, patient discharge, or patient death.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE Device: InfraScanner 2000™
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.
Study Arms  ICMJE Experimental: InfraScanner 2000™
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.
Intervention: Device: InfraScanner 2000™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2019)
500
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
360
Actual Study Completion Date  ICMJE May 4, 2018
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03353246
Other Study ID Numbers  ICMJE Pro00087011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Haglund, MD, PhD Duke University
PRS Account Duke University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP