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CompletedNCT03353246Updated Aug 20, 2019Results posted

Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

An interventional study of InfraScanner 2000™ in Head Trauma, Craniocerebral Injuries and Crushing Skull Injury, sponsored by Duke University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-08-20.

Primary conditionHead Injuries, ClosedRegistry: Craniocerebral TraumaReclassifiedWhy we changed it
Registry
Craniocerebral Trauma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Head Injuries, Closed
Why
  1. The study's listed conditions name Head Injuries, Closed, a narrower term within Craniocerebral Trauma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Duke University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • 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

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03

In context

Head Injuries, Closed Reclassified

33 studies on the registry are indexed under Head Injuries, Closed; 3 are open to participants now.

This study's enrollment of 500 is above the median of 77 across 25 interventional studies indexed under Head Injuries, Closed.

Browse Head Injuries, Closed studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Browse Duke University studies →

Compared within Head Injuries, Closed, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Craniocerebral Trauma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (actual)

Study arms

  • 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.

    Device: InfraScanner 2000™

Interventions

  • DeviceInfraScanner 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 30 days after first CT scan

  2. 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.

    Time frame: Up to 30 days after first CT scan

  3. 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.

    Time frame: Up to 30 days after first CT scan

  4. 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.

    Time frame: Up to 30 days after first CT scan

  5. 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.

    Time frame: Up to 30 days after first CT scan

  6. 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.

    Time frame: Up to 30 days after first CT scan

  7. 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.

    Time frame: Up to 30 days after first CT scan

  8. 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.

    Time frame: Up to 30 days after first CT scan

Secondary outcomes

  1. 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.

    Time frame: Up to 30 days after first CT scan

  2. 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.

    Time frame: Up to 30 days after first CT scan

  3. 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.

    Time frame: Up to 30 days after first CT scan

  4. 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.

    Time frame: Up to 30 days after first CT scan

  5. 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.

    Time frame: Up to 30 days after first CT scan

  6. 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.

    Time frame: Up to 30 days after first CT scan

07

Results

Posted May 28, 2019

Participant flow

Participant flow — Overall Study
MilestoneInfraScanner 2000™
Started500
Completed500
Not completed0

Outcome measures

PrimarySensitivity 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level
percentageInfraScanner 2000™
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level85.6 (78.8 to 92.3)
PrimarySensitivity 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level
percentageInfraScanner 2000™
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level88.5 (83.8 to 93.1)
PrimarySpecificity 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
percentageInfraScanner 2000™
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level95.7 (93.7 to 97.7)
PrimarySpecificity 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
percentageInfraScanner 2000™
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level95.5 (93.5 to 97.5)
PrimaryFalse 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
percentageInfraScanner 2000™
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level16.0 (9.1 to 23.0)
PrimaryFalse 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
percentageInfraScanner 2000™
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level10.1 (5.7 to 14.5)
PrimaryFalse 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
percentageInfraScanner 2000™
False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level3.8 (1.9 to 5.7)
PrimaryFalse 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
percentageInfraScanner 2000™
False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level5.2 (3.1 to 7.4)
SecondarySensitivity 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level
percentageInfraScanner 2000™
Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level94.2 (89.2 to 99.1)
SecondarySpecificity 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level
percentageInfraScanner 2000™
Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level95.7 (93.7 to 97.7)
SecondarySensitivity 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
percentageInfraScanner 2000™
epidural hematoma (EDH)100.0 (54.1 to 100.0)
subdural hematoma (SDH)96.9 (92.6 to 100.0)
subarachnoid (SAH)75.0 (50.5 to 99.5)
intracerebral (IH)100.0 (79.4 to 100.0)
SecondaryFalse 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
percentageInfraScanner 2000™
epidural hematoma (EDH)0.0 (0.0 to 0.97)
subdural hematoma (SDH)0.5 (0.0 to 1.3)
subarachnoid (SAH)0.8 (0.0 to 1.7)
intracerebral (IH)0.0 (0.0 to 0.97)
SecondarySensitivity 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
percentageInfraScanner 2000™
epidural hematoma (EDH)90.9 (73.9 to 100.0)
subdural hematoma (SDH)98.3 (96.0 to 100.0)
subarachnoid (SAH)88.0 (75.3 to 100.0)
intracerebral (IH)96.2 (88.8 to 100.0)
SecondaryFalse 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.

Time frame:
Up to 30 days after first CT scan
Reported as:
Number · percentage
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
percentageInfraScanner 2000™
epidural hematoma (EDH)0.3 (0.0 to 0.8)
subdural hematoma (SDH)0.5 (0.0 to 1.3)
subarachnoid (SAH)0.8 (0.0 to 1.7)
intracerebral (IH)0.3 (0.0 to 0.8)

Adverse events

Collected over During the time of the scan with the InfraScanner, up to 10 minutes. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
InfraScanner 2000™0/500 (0%)0/500 (0%)0/500 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)InfraScanner 2000™
Mean55.4 ± 25.4
Sex: Female, Male
Sex: Female, Male(Participants)InfraScanner 2000™
Female211
Male289
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)InfraScanner 2000™
Hispanic or Latino104
Not Hispanic or Latino396
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)InfraScanner 2000™
American Indian or Alaska Native0
Asian28
Native Hawaiian or Other Pacific Islander10
Black or African American168
White231
More than one race63
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)InfraScanner 2000™
United States500
08

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in May 2018, 4 months.

Results were first posted in May 2019, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2017
First posted
Nov 27, 2017
StartActual
Dec 11, 2017
Primary completionActual
May 4, 2018
CompletionActual
May 4, 2018
Results first posted
May 28, 2019
Last update
Aug 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03353246
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Nov 27, 2017
Start date
Dec 11, 2017
Primary completion
May 4, 2018
Completion
May 4, 2018
Results posted
May 28, 2019
Last update
Aug 20, 2019

Study contacts

Michael Haglund, MD, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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