Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorThe Geneva Foundation
About this trial
Traumatic Brain Injury (TBI) is a leading cause of death and disability among military personnel, Veterans, and civilians. One of the most dangerous complications of moderate-to-severe TBI is intracranial hemorrhage (ICH). If not identified and treated promptly, ICH can rapidly lead to worsening neurological damage or death. Current diagnostic tools, such as CT scans, are highly effective but impractical for battlefield or resource-limited environments due to their large size and infrastructure dependency.
The Near-Infrared Detection-Head Imaging (NIRD-HI) system is an innovative, noninvasive device using Near-Infrared Spectroscopy (NIRS) to identify abnormal blood accumulation. Unlike traditional tools, NIRD-HI is compact, lightweight, and portable, making it suitable for remote or austere settings. By dynamically imaging the brain, it generates 3D visualizations that pinpoint the size and location of bleeds, including complex bilateral injuries. This offers a significant improvement over current point-of-injury technologies that lack the resolution to reliably diagnose all forms of ICH.
This study supports the FY24 Combat Readiness Medical Research Program by advancing battlefield diagnostic and triage capabilities. The research will:
* Evaluate NIRD-HI's accuracy compared to CT imaging. * Assess feasibility in real-world acute care settings. * Investigate its ability to monitor changes in ICH over time.
These objectives address the military's need for tools that improve rapid diagnosis and decision-making during emergencies. Implementing this research can revolutionize TBI management. For Service Members, NIRD-HI promises a field-ready solution for early detection, enabling faster intervention and more effective triage. By reducing diagnostic delays, it could save lives and prevent long-term complications. Furthermore, the system supports prolonged field care by providing continuous monitoring of evolving injuries.
The benefits extend to civilian healthcare, particularly in rural or underserved areas lacking advanced imaging. This accessibility can improve trauma care outcomes for millions, reduce the burden on healthcare systems, and provide equitable distribution of life-saving technology. By addressing gaps in battlefield medicine, this project aims to enhance medical readiness and improve survivability in the most challenging environments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 to 89 years of age
Able to provide written informed consent either by self or legally authorized representative
Received head CT imaging on admission
Able to complete at least one NIRD-HI scan within 4 hours of head CT
Disqualifiers
Presence of penetrating or non-survivable injuries
Hemorrhagic shock or large volume transfusion [>3 units of any blood product within
Large open skull wounds, scalp lacerations or surface hematomas prohibiting safe or comfortable sensor placement
Presence of heat tattoos or intracranial metal fixtures
Trial population
Access to the proposed population includes a mixture of 15% active-duty military and/or VA patients and 85% civilians from central/southern Texas, including the 22 surrounding counties that are receiving trauma care at Brooke Army Medical Center. Daily review of the Trauma census will be conducted to review eligible patients. This screening tool will help determine, predict, and address challenges to recruitment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NIRD-HI scan at the time of enrollment
Diagnostic testAll enrolled patients who meet the study's eligibility criteria will receive one NIRD-HI scan at the time of enrollment.
Secondary NIRD-HI scan when a planned repeat CT is performed
Diagnostic testFor patients requiring a planned repeat CT, a secondary NIRD-HI scan may be performed before the subsequent CT imaging.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: 40 participants with positive head bleed on CT report2 interventions
Group B: 40 participants with negative head bleed on CT report2 interventions
Trial outcomes
Primary outcomes
1
Diagnostic Performance
Diagnostic Performance. Establish the sensitivity, specificity, PPV, and NPV of the NIRD-HI system for detecting ICH in TBI patients, with a target sensitivity and specificity exceeding 90%.
Time frame
Baseline, at time of NIRD-HI testing administered2
Feasibility Assessment - Scan Time
Time in minutes to complete scans in acute care setting recorded on a templated study log including scan start/stop time, interruptions and reasons for interruptions, technical errors and unanticipated device adverse events.
Time frame
Enrollment through study completion, an average of 1 year3
Feasibility Assessment - Operator Usability
Operator usability near the end of the recruitment period, 4-6 blinded clinicians (physicians and/or mid-level practritioners) will make a determination of criteria positive or negative research scans assigned in random order to establish statistics for inter-reader agreement. Blinded readers will assign a likelihood score using a Visual Analog Scale \[VAS\] to indicate how confident they are in their read.
Time frame
Near the end of recruitment period, an average of 1 year4
Feasibility Assessment - Device Integration
Device integration, through operator feedback questionnaire regarding ease of use.
Time frame
Enrollment through study completion, an average of 1 yearSecondary outcomes
1
Diagnostic Performance - Time Detection of ICH
Start/stop times of NIRD-HI readouts will be correlated with Head CT results after each scan for accuracy and start/stop times of scans.
Time frame
Baseline, at time of NIRD-HI testing administered2
Diagnostic Performance - Operator Performance
Ability to perform NIRD-HI scans \[i\] scans not performed for subjectreasons \[e.g. wounds, bandages, c-spine protection\]; \[ii\] scans not performed for operator reasons \[e.g. inability to use device correctly); \[iii\] scans not performed because of technical issues with the device; and \[c\] inter-reader agreement.
Time frame
Baseline, at time of NIRD-HI testing administered3
Accuracy of evolution testing [first NIRD HI scan vs. second NIRD HI]
A subset of subjects with available follow-up head CT will be compared to changes confirmed by CT imaging, to evaluate the efficacy of the device for monitoring intracranial hemorrhages.
Time frame
Baseline, at time of NIRD-HI testing administeredSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Geneva Foundation
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Uniformed Services University of the Health Sciences
Collaborator
Source ClinicalTrials.gov
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