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

Conditions

• Combat Casualty Care
• Intracranial Hemorrhages
• Point of Care
• Traumatic Brain Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Accepted

Interventions

• NIRD-HI scan at the time of enrollment — DIAGNOSTIC_TEST
  All 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_TEST
  For patients requiring a planned repeat CT, a secondary NIRD-HI scan may be performed before the subsequent CT imaging.

Study Details

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 Dates

Start date

Jan 1, 2026

Status verified

Jan 2026

Primary completion

Sep 29, 2027

Completion

Sep 29, 2027

Study Design

Enrollment

80 participants (estimated)

Arms

• Arm: 40 participants with positive head bleed on CT report
  Subjects with positive head CT reports that may have a diagnosis of TBI or intracranial hemorrhage
• Arm: 40 participants with negative head bleed on CT report
  Subjects without positive head CT reports that may have a diagnosis of TBI or intracranial hemorrhage

Primary Outcome Measure

Diagnostic Performance [ Time Frame: Baseline, at time of NIRD-HI testing administered ]

Central Contacts

• Marisol Resendiz, PhD
  210-916-5821
  [email protected]

Locations (1)

Find similar trials in San Antonio, TX

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