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

Launched by INFRASCAN, INC. · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial, called SAFETY, is studying a handheld device called the Infrascanner Model 2500, which helps doctors quickly identify traumatic brain injuries, like bleeding in the brain, in patients who have been injured in combat. The goal is to see if using this device can speed up the process of diagnosing these injuries and improve patient care in war zones. The study will take place in various hospitals in Ukraine, where patients showing signs of head trauma will be monitored.

To participate, individuals must have suspected combat-related head injuries, which can be identified by certain signs like a lower level of consciousness, unusual pupil responses, or differences in arm and leg movement. Patients with severe scalp injuries that make it hard to use the Infrascanner will not be eligible. Throughout the trial, participants can expect to receive standard medical care, and their progress will be tracked both before and after the device is introduced to see if it helps doctors diagnose injuries more quickly. This research is important because it aims to improve how brain injuries are detected and treated in challenging environments.

Gender

ALL

Eligibility 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