Observational Study of the NIRD-HI Device for Traumatic Brain Injury
This study is looking at a new, portable device called the Near-Infrared Detection-Head Imaging (NIRD-HI) system. This device uses light (Near-Infrared Spectroscopy or NIRS) to find abnormal blood in the brain, which can happen after a traumatic brain injury (TBI). The goal is to see how well the NIRD-HI system can detect these bleeds compared to standard CT scans, especially in places where CT scans aren't available. You might be able to join if you are 18-89 years old, have had a head CT scan, and are not having surgery for your injury. The study will also look at how easy and quick the NIRD-HI device is to use. The current status of this study is unclear.
- Study design
- This is an observational study with a planned enrollment of 80 participants. It is not specified if this study is randomized or blinded.
- What's involved
- You would receive one NIRD-HI scan when you enroll. If you need another CT scan later, you might receive a second NIRD-HI scan before that CT.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess how long scans take from enrollment through study completion, which is an average of one year. Operator usability will also be assessed for about one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI)
At a glance
Conditions
NCT07338383
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Brooke Army Medical Center
San Antonio, Texasstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Julie Rizzo, MD · PRINCIPAL_INVESTIGATOR · Brooke Army Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Diagnostic PerformanceBaseline, at time of NIRD-HI testing administered
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%.
- Feasibility Assessment - Scan TimeEnrollment through study completion, an average of 1 year
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.
- Feasibility Assessment - Operator UsabilityNear the end of recruitment period, an average of 1 year
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.
- Feasibility Assessment - Device IntegrationEnrollment through study completion, an average of 1 year
Device integration, through operator feedback questionnaire regarding ease of use.
- Monitoring of ICH ProgressionBaseline, at time of NIRD-HI testing administered
NIRD-HI readouts for the presence/absence of ICH and region of detection \[if positive\] as determined by the research device. NIRD-HI readouts will be correlated with Head CT results after each scan.