Condition: Traumatic Brain Hemorrhage · Sponsor: InfraScan, Inc.
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 K241389 approved higher laser power use to address dark skinned patients in 2024. This non randomized observational study aims to evaluate the utility of this device by evaluating its ability to provide decision support information to optimize care for patients with suspected traumatic intracranial hematomas. It is important to note that the intended use of the device is in accordance with its FDA approved indication. The intent is to generate actionable knowledge that along with standard clinical signs, facilitates the early detection of intracranial hemorrhage (ICH) in patients with suspected traumatic brain injury (TBI) in a combat setting. The ultimate goal is to modify and optimize international protocols for inexpensive, bedside, portable, and noninvasive detection of traumatic ICH in conflict zones across the globe. This multicenter, prospective, observational, implementation science study will evaluate the field utility of the Infrascanner Model 2500 in an active combat setting using a pragmatic, sequential research design consisting of two phases-baseline phase and device phase. Using the current Ukrainian medical care system, patients with suspected TBIs will be monitored, and their outcomes will be tracked using standard-of-care practices (ba…
This description comes directly from the study's public registry record.
Baruch Ben Dor, PhD · 610-608-3112 · bbendor@infrascanner.com
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT07014748