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NCT07338383 · ClinicalTrials.gov registry record
Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI)
A clinical trial, sponsored by The Geneva Foundation.
- Not yet
- Registry status
- 80
- Enrollment target
NCT07338383: Clinical Trial study, sponsored by The Geneva Foundation.
NCT07338383 is a clinical trial that has not yet begun recruiting, run by The Geneva Foundation. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07338383 has not yet begun recruiting, sponsored by The Geneva Foundation.
- NOT YET RECRUITING
- Registry status
- 80 participants
- Enrollment target
Study Summary
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,
Primary Outcome
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%.
Interventions
- DIAGNOSTIC_TEST NIRD-HI scan at the time of enrollment
- DIAGNOSTIC_TEST Secondary NIRD-HI scan when a planned repeat CT is performed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2027-09-29 |
What is known before NCT07338383 opens enrollment
NCT07338383 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which NIRD-HI scan at the time of enrollment is the first listed.
NCT07338383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07338383 about?
NCT07338383 is a clinical study titled "Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI)". 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 neu...
What is the current status of trial NCT07338383?
This trial is currently not yet recruiting. The enrollment target is 80 participants. The study started on 2026-01-01. Estimated completion is 2027-09-29.
What interventions are being tested in trial NCT07338383?
The interventions under investigation include: NIRD-HI scan at the time of enrollment (DIAGNOSTIC_TEST), Secondary NIRD-HI scan when a planned repeat CT is performed (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07338383?
This trial is sponsored by The Geneva Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.
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