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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
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
Intervention Device: InfraScanner 2000™
Enrollment 500
Recruitment Details  
Pre-assignment Details  
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 500
Completed 500
Not Completed 0
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description

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.

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.

Overall Number of Baseline Participants 500
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 500 participants
55.4  (25.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants
Female
211
  42.2%
Male
289
  57.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants
Hispanic or Latino
104
  20.8%
Not Hispanic or Latino
396
  79.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants
American Indian or Alaska Native
0
   0.0%
Asian
28
   5.6%
Native Hawaiian or Other Pacific Islander
10
   2.0%
Black or African American
168
  33.6%
White
231
  46.2%
More than one race
63
  12.6%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 500 participants
500
1.Primary Outcome
Title Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
For participants who had more than one scan, the first scan was used.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 500
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
85.6
(78.8 to 92.3)
2.Primary Outcome
Title Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 500
Overall Number of Units Analyzed
Type of Units Analyzed: Scans
581
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
88.5
(83.8 to 93.1)
3.Primary Outcome
Title Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
For participants who had more than one scan, the first scan was used.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 500
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
95.7
(93.7 to 97.7)
4.Primary Outcome
Title Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 500
Overall Number of Units Analyzed
Type of Units Analyzed: Scans
581
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
95.5
(93.5 to 97.5)
5.Primary Outcome
Title False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
For participants who had more than one scan, the first scan was used.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 500
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
16.0
(9.1 to 23.0)
6.Primary Outcome
Title False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 500
Overall Number of Units Analyzed
Type of Units Analyzed: Scans
581
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
10.1
(5.7 to 14.5)
7.Primary Outcome
Title False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
For participants who had more than one scan, the first scan was used.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 500
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
3.8
(1.9 to 5.7)
8.Primary Outcome
Title False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 500
Overall Number of Units Analyzed
Type of Units Analyzed: Scans
581
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
5.2
(3.1 to 7.4)
9.Secondary Outcome
Title Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 482
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
94.2
(89.2 to 99.1)
10.Secondary Outcome
Title Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 482
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
95.7
(93.7 to 97.7)
11.Secondary Outcome
Title Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 482
Overall Number of Units Analyzed
Type of Units Analyzed: Hematomas
98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
epidural hematoma (EDH) Number Analyzed 6 Hematomas
100.0
(54.1 to 100.0)
subdural hematoma (SDH) Number Analyzed 64 Hematomas
96.9
(92.6 to 100.0)
subarachnoid (SAH) Number Analyzed 12 Hematomas
75.0
(50.5 to 99.5)
intracerebral (IH) Number Analyzed 16 Hematomas
100.0
(79.4 to 100.0)
12.Secondary Outcome
Title False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 482
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
epidural hematoma (EDH) Number Analyzed 6 participants
0.0
(0.0 to 0.97)
subdural hematoma (SDH) Number Analyzed 64 participants
0.5
(0.0 to 1.3)
subarachnoid (SAH) Number Analyzed 12 participants
0.8
(0.0 to 1.7)
intracerebral (IH) Number Analyzed 16 participants
0.0
(0.0 to 0.97)
13.Secondary Outcome
Title Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 482
Overall Number of Units Analyzed
Type of Units Analyzed: CT scans
180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
epidural hematoma (EDH) Number Analyzed 10 CT scans
90.9
(73.9 to 100.0)
subdural hematoma (SDH) Number Analyzed 119 CT scans
98.3
(96.0 to 100.0)
subarachnoid (SAH) Number Analyzed 25 CT scans
88.0
(75.3 to 100.0)
intracerebral (IH) Number Analyzed 26 CT scans
96.2
(88.8 to 100.0)
14.Secondary Outcome
Title False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 482
Overall Number of Units Analyzed
Type of Units Analyzed: CT scans
180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
epidural hematoma (EDH) Number Analyzed 10 CT scans
0.3
(0.0 to 0.8)
subdural hematoma (SDH) Number Analyzed 119 CT scans
0.5
(0.0 to 1.3)
subarachnoid (SAH) Number Analyzed 25 CT scans
0.8
(0.0 to 1.7)
intracerebral (IH) Number Analyzed 26 CT scans
0.3
(0.0 to 0.8)
Time Frame During the time of the scan with the InfraScanner, up to 10 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title InfraScanner 2000™
Hide Arm/Group Description

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.

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.

All-Cause Mortality
InfraScanner 2000™
Affected / at Risk (%)
Total   0/500 (0.00%) 
Hide Serious Adverse Events
InfraScanner 2000™
Affected / at Risk (%)
Total   0/500 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
InfraScanner 2000™
Affected / at Risk (%)
Total   0/500 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Haglund, M.D., Ph.D.
Organization: Duke University Medical Center
Phone: 919-684-6936
EMail: haglu001@mc.duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03353246    
Other Study ID Numbers: Pro00087011
First Submitted: November 21, 2017
First Posted: November 27, 2017
Results First Submitted: May 3, 2019
Results First Posted: May 28, 2019
Last Update Posted: August 20, 2019