Clinical trials: Hematoma Intracranial
- Condition Hematoma Intracranial
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Traumatic Brain Hemorrhage
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
The Infrascanner model 2500 is a handheld, noninvasive device that is FDA-cleared to detect traumatic intracranial hematomas. FDA clearance K200203 was issued in 2020, K211617 added pediatric age group to the IFU in 2022, and…
- Trial name
- SAFETY (NCT07014748)
- Testing
- Handheld brain hematoma detector
- Where
- 4 sites in United States, Ukraine
- Volunteers
- 600 people
- Sponsor
- InfraScan, Inc.