Head TraumaNCT03353246

Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

A study testing InfraScanner 2000™ in people with Head Trauma and Craniocerebral Injuries, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Head Trauma, Craniocerebral Injuries, Crushing Skull Injury
What is being tested?: InfraScanner 2000™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 1 siteUnited States
Study dates: 11 Dec 2017to 4 May 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

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

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.

Conditions: Head Trauma, Craniocerebral Injuries, Crushing Skull Injury, Head Injuries, Head Injuries, Multiple, Head Injuries, Closed
Being tested: InfraScanner 2000™
Medical subject headings: Craniocerebral Trauma, Head Injuries, Closed, Head Injuries, Penetrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03353246
Study group	Role	What they receive
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. Receives: Device: InfraScanner 2000™

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 30 days after first CT scan

Secondary outcomes (6)

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.
Measured: Up to 30 days after first CT scan
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.
Measured: Up to 30 days after first CT scan
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.
Measured: Up to 30 days after first CT scan
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.
Measured: Up to 30 days after first CT scan
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.
Measured: Up to 30 days after first CT scan
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.
Measured: Up to 30 days after first CT scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 20174 May 2018

First posted27 Nov 2017
Study start11 Dec 2017
Primary completion4 May 2018
Study completion4 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Head TraumaStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03353246
Sponsor's protocol ID: Pro00087011
Status last verified: Apr 2019
First submitted: 21 Nov 2017
Last updated: 20 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
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All Head Trauma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03353246
Acronym / sponsor ID: Pro00087011
Conditions: Head Trauma, Craniocerebral Injuries, Crushing Skull Injury, Head Injuries, Head Injuries, Multiple, Head Injuries, Closed
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 11 Dec 2017 (actual)
Primary completion: 4 May 2018 (actual)
Study completion: 4 May 2018 (actual)
First posted: 27 Nov 2017 (actual)
Results: Posted 28 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
InfraScanner 2000™	Experimental	Device: 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	InfraScanner 2000™

Primary outcome

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.

6 secondary outcomes

Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level
Time frame: Up to 30 days after first CT scan
Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level
Time frame: Up to 30 days after first CT scan
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
Time frame: Up to 30 days after first CT scan
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
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
Time frame: Up to 30 days after first CT scan
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

Results and safety

Results posted to the registry on 28 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
InfraScanner 2000™	500	500

Primary outcome: Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level

Time frame: Up to 30 days after first CT scan. Number (95% Confidence Interval). Unit: percentage

Measure	InfraScanner 2000™ n = 500
Value	85.6 (78.8 to 92.3)

Population analysed: For participants who had more than one scan, the first scan was used.

Primary outcome: Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level

Time frame: Up to 30 days after first CT scan. Number (95% Confidence Interval). Unit: percentage

Measure	InfraScanner 2000™ n = 500
Value	88.5 (83.8 to 93.1)

Population analysed: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.

Primary outcome: 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. Number (95% Confidence Interval). Unit: percentage

Measure	InfraScanner 2000™ n = 500
Value	95.7 (93.7 to 97.7)

Population analysed: For participants who had more than one scan, the first scan was used.

Primary outcome: 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. Number (95% Confidence Interval). Unit: percentage

Measure	InfraScanner 2000™ n = 500
Value	95.5 (93.5 to 97.5)

Population analysed: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the time of the scan with the InfraScanner, up to 10 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
InfraScanner 2000™	0 of 500 (0%)	0 of 500 (0%)	0 of 500

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Head Trauma

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Not yet recruitingPhase 1
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RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
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Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Haglund, MD, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing InfraScanner 2000™ in people with Head Trauma and Craniocerebral Injuries, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level (time frame: Up to 30 days after first CT scan). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03353246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.