Head TraumaNCT04505293
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 2 sites in 2 countries.
Trial 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… Read more about this study
- 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
- 672 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Oct 2021to 5 Aug 2022
- 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 MRRH with suspected head trauma, who is able to or who has a legally authorized representative who is able consent in English, Swahili, or Luganda will be considered for this study.
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
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 and Mbarara Regional Referral 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 Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
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 Computed Tomography (CT) scans over the course of his or her hospitalization, affording the opportunity of one to numerous measurements from each patient during his or her hospital stay.
Upon presentation to the casualty unit at MRRH and following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image A). If permission is granted, the study team member sequentially measure the optical absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and occipital bilaterally) (Image B). The device is engineered such that the light emitter and receiver are spaced 4 cm apart, allowing the light's intensity to be measured between adjacent light guides (Image C). This entire procedure, including greeting and scanning the patient should take <10 minutes. Subsequent CT scan(s) the patient receives determines the number of potential data collections.
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 the Research Electronic Data Capture (REDCap) database and/or Microsoft Excel 2016 on a secured network drive within the Department of Neurosurgery at Duke.
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 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™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. 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.
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status
Determine whether the InfraScanner 2000 detects epidural and/or subdural hematomas with adequate precision relative to CT scans. Precision is defined as the number of True Positives (Infrascanner says there is a hematoma and the CT shows a hematoma) and True Negatives (Infrascanner says there is NOT a hematoma and the CT does NOT show a hematoma).
Measured: Within 30 minutes following CT scan
Secondary outcomes (5)
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma)
Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume >3.5 mL) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (>3.5 ml in volume) or depths (<2.5 cm from the skull) were used.
Measured: Within 30 minutes following CT scan
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma)
Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (depth <2.5 cm) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (>3.5 ml in volume) or depths (<2.5 cm from the skull) were used.
Measured: Within 30 minutes following CT scan
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE)
Clinical patient outcomes as measured by the Glasgow Outcomes Scale (GOSE) at discharge. The GOSE is rated from 1 to 8, 1 being death and 8 being upper good recovery.
Measured: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Identify Reasons CT Not Performed
CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT.
Measured: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Causes of Head Trauma as Identified Through the Medical Record
RTA = Road Traffic Accident
Measured: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start5 Oct 2021
- Primary completion29 Jun 2022
- Study completion5 Aug 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Haglund, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505293
- Sponsor's protocol ID
- Pro00087011_1
- Status last verified
- Feb 2024
- First submitted
- 22 Jul 2020
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Liow YY, Ukachukwu AK, Iversen ES, Ordonez YT, Gramer R, Shlobin NA, Najjuma JN, Fuller AT, Haglund MM, Kitya D, Kolls BJ. Assessment of a Handheld Near-Infrared Light Device in Detecting Intracranial Hematomas in Mbarara, Uganda. Neurosurgery. 2026 Aug 1;99(2):470-478. doi: 10.1227/neu.0000000000003873. Epub 2025 Dec 8.
PubMed 41358727
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. 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 and Mbarara Regional Referral Hospital: A Pilot Study
- ClinicalTrials.gov ID
- NCT04505293
- Acronym / sponsor ID
- Pro00087011_1
- Conditions
- Head Trauma, Craniocerebral Injuries, Crushing Skull Injury, Head Injuries, Head Injuries, Multiple, Head Injuries, Closed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
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 Computed Tomography (CT) scans over the course of his or her hospitalization, affording the opportunity of one to numerous measurements from each patient during his or her hospital stay.
Upon presentation to the casualty unit at MRRH and following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image A). If permission is granted, the study team member sequentially measure the optical absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and occipital bilaterally) (Image B). The device is engineered such that the light emitter and receiver are spaced 4 cm apart, allowing the light's intensity to be measured between adjacent light guides (Image C). This entire procedure, including greeting and scanning the patient should take <10 minutes. Subsequent CT scan(s) the patient receives determines the number of potential data collections.
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 the Research Electronic Data Capture (REDCap) database and/or Microsoft Excel 2016 on a secured network drive within the Department of Neurosurgery at Duke.
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™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. 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 MRRH with suspected head trauma, who is able to or who has a legally authorized representative who is able consent in English, Swahili, or Luganda 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
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status
Time frame: Within 30 minutes following CT scan
Determine whether the InfraScanner 2000 detects epidural and/or subdural hematomas with adequate precision relative to CT scans. Precision is defined as the number of True Positives (Infrascanner says there is a hematoma and the CT shows a hematoma) and True Negatives (Infrascanner says there is NOT a hematoma and the CT does NOT show a hematoma).
5 secondary outcomes
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma)
Time frame: Within 30 minutes following CT scan
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma)
Time frame: Within 30 minutes following CT scan
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE)
Time frame: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Identify Reasons CT Not Performed
Time frame: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Causes of Head Trauma as Identified Through the Medical Record
Time frame: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41358727Liow YY, Ukachukwu AK, Iversen ES, Ordonez YT, Gramer R, Shlobin NA, Najjuma JN, Fuller AT, Haglund MM, Kitya D, Kolls BJ. Assessment of a Handheld Near-Infrared Light Device in Detecting Intracranial Hematomas in Mbarara, Uganda. Neurosurgery. 2026 Aug 1;99(2):470-478. doi: 10.1227/neu.0000000000003873. Epub 2025 Dec 8.
- Individual participant dataSharing planned: No
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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
2 sites in 2 countries: 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 2 sites in 2 countries.
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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Uganda. 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 19 Mar 2024). 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?
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (time frame: Within 30 minutes following CT scan). 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 NCT04505293, which also lists 1 linked publication.
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 19 Mar 2024.