Handheld Infrascanner use to help detect traumatic brain bleeding in combat and hospital settings
SAFETY: Stabilization Points to Third Hospital Line Assessment oF the Impact of the usE of Infrascanner Model 2500 to Provide Decision Support for Diagnosis/Screening of Traumatic Brain InjurY in Ukraine
This study will test whether a handheld Infrascanner can help medical teams quickly detect brain bleeding in people with suspected combat-related head injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | InfraScan, Inc. Industry-sponsored |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT07014748 on ClinicalTrials.gov |
What this trial studies
This is a non-randomized observational project using the FDA-cleared Infrascanner Model 2500 as a bedside, noninvasive decision-support tool for suspected traumatic intracranial hematomas. The device will be used according to its approved indications and recent label updates for pediatric patients and darker skin tones, and findings will be collected alongside routine clinical exams. Patients with suspected combat-related head trauma who show clinical signs of TBI will be enrolled at participating military and civilian hospitals in the U.S. and Ukraine. Scalp wounds that prevent proper device placement will exclude participation.
Who should consider this trial
Good fit: Ideal candidates are people presenting with suspected combat-related head trauma who show clinical signs of TBI (reduced GCS, abnormal pupils, or asymmetric motor exam) and can have the device placed on the scalp.
Not a fit: Patients with extensive scalp lacerations, avulsions, or abrasions that prevent proper device placement or whose injuries do not produce focal hematomas detectable by near-infrared scanning are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could help clinicians identify intracranial bleeding sooner and speed triage and transfer decisions for people with head injuries.
How similar studies have performed: Prior versions of handheld near-infrared scanners, including earlier Infrascanner approvals, have demonstrated utility and received FDA clearance, though evidence in combat settings and diverse skin tones is still being expanded.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with suspected combat-related head trauma identified by clinical signs of TBI on admission to the clinical enrollment site * Clinical signs of TBI: * Decreased GCS score * Abnormal pupil exam * Asymmetrical motor exam * The presence of pharmacologic sedation is not exclusion criteria. Exclusion Criteria: * Evidence of extensive scalp injury that prevent proper placement of the Infrascanner device on a subject's head or prevent placement of the device in the specified locations. * Extensive scalp injury includes lacerations, avulsions, or abrasions
Where this trial is running
Birmingham, Alabama and 3 other locations
- University of Alabama in Birmingham — Birmingham, Alabama, United States (Active_not_recruiting)
- Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov of Dnipropetrovsk Regional Council — Dnipro, Ukraine (Recruiting)
- Ukrainian Military — Kyiv, Ukraine (Recruiting)
- Vinnytsia City Clinical Hospital named after M.I.Pirogov of Vinnitsya Regional Council — Vinnytsia, Ukraine (Recruiting)
Study contacts
- Principal investigator: Dmytro Dmytriiev, MD, PhD, MBA — Vinnytsia City Clinical Hospital named after M.I.Pirogov of Vinnitsya Regional Council
- Study coordinator: Baruch Ben Dor, PhD
- Email: bbendor@infrascanner.com
- Phone: 610-608-3112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.