Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI)

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Conditions studied: Traumatic Brain Injury, Intracranial Hemorrhages, Combat Casualty Care, Point of Care

In brief

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.

Key facts

Study ID: NCT07338383
Run by: The Geneva Foundation
People needed: 80
Starts: 2026-01-01
Expected to finish: 2027-09-29
Last updated by the study team: 2026-01-13

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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
Non-operative management planned

You may not qualify if…

Presence of penetrating or non-survivable injuries
Hemorrhagic shock or large volume transfusion [>3 units of any blood product within
1 hour of scan]
Large open skull wounds, scalp lacerations or surface hematomas prohibiting safe or comfortable sensor placement
Presence of heat tattoos or intracranial metal fixtures
Cervical injury prolonging C-spine collar
Known prisoners or wards of state
Any condition or finding that makes the patient unsuitable for image acquisition in the Investigator's opinion

Where it is running

Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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