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

NCT07014748 | Recruiting FDA Device

• 1 other identifier: 24-01-MPAI-179
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 4

Brief Summary

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 (baseline phase). After the baseline data collection period is complete, an amendment to the protocol will be submitted to initiate the device phase. After training and upon approval, the Infrascanner device will be deployed to the facilities described above to provide health care providers with additional decision support, and the impact of its use will be compared to the baseline data. The outcome of interest is the time from admission at each enrollment study location to a definitive CT scan diagnosis of ICH. The investigators hypothesize that the use of the device will provide decision support to health care providers, decrease the time to traumatic ICH detection, thus enabling more expedient care. This prospective study will include all patients with suspected combat-related head trauma identified by clinical signs of TBI, such as decreased GCS score, abnormal pupil exam, and/or asymmetrical motor exam, on admission to the clinical enrollment site (mobile hospital or regional clinical hospital) regardless of the presence of pharmacologic sedation. At the Vinnytsia hospital (Role 4), combat polytrauma preoperative patients will also be screened. Exclusion criteria include evidence of extensive scalp injury, including lacerations, avulsions, or abrasions that prevent proper placement of the Infrascanner device on a subject's head or prevent placement of the device in the specified locations. During the baseline phase (Figure 1), 100 patients will be enrolled at stabilization points and the mobile/first-line hospital, 100 will be enrolled at the second-line hospital, and 100 will be enrolled at the third-line hospital. Thus, from a total of 300 subjects, baseline data on the time from admission at each enrollment study location to a definitive CT scan diagnosis of ICH and treatment and early outcomes will be collected. Once the baseline phase is complete and the amendment for the device phase is approved, it will be initiated. During this device phase, the Infrascanner will be deployed to stabilization points and the three levels of care (mobile hospitals and regional clinical hospitals). Data collection will continue until 100 patients are enrolled in the device phase for the three levels of care. All data collection at the baseline and device phases will occur at the same locations, and the data elements will be identical, except for Infrascanner data collected during the device phase. By comparing data from the baseline and device phase, the investigators will assess the utility of the device to provide decision support information to providers and potentially reduce time to definitive diagnosis by CT scan and thus treatment, as well as the association between Infrascanner use and early patient outcomes.

Conditions

Traumatic Brain Hemorrhage

Keywords

TBI; ICH; Intracranial hematoma; Ukraine; Trauma; NIRS; Near Infrared

Outcome Measures

Primary Outcomes (1)

• Time from admission to definitive diagnosis

  Evaluate the time from admission at each enrollment study location to a definitive CT scan diagnosis of intracranial hemorrhage (ICH).

  From admission at each enrollment study location to a definitive CT scan diagnosis of intracranial hemorrhage (ICH), which is up to 24 hours from admission.

Secondary Outcomes (2)

• Final Glasgow Coma Scale at discharge or transfer

  From admission to the hospital until 3 days from admission

• Number of Brain-related complications

  From admission to the hospital until 3 days from admission

Study Arms (2)

Baseline Phase

Patients with suspected combat-related head trauma who are admitted to the participating hospitals will be eligible for enrollment in this trial. These patients will receive the current standard of care.

Device Phase

Patients with suspected combat-related head trauma who are admitted to the participating hospitals will be eligible for enrollment in this trial. These patients will receive the current standard of care and the Infrascanner model 2500 will be added to the diagnosis and clinical decision.

Diagnostic Test: Handheld brain hematoma detector

Interventions

Handheld brain hematoma detector DIAGNOSTIC_TEST

Near Infrared based handheld traumatic brain hematoma detector

Also known as: Infrascanner Model 2500

Device Phase

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected combat-related head trauma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InfraScan, Inc.: lead
• USARMY USAMRMC: collaborator

Study Sites (4)

University of Alabama in Birmingham

Birmingham, Alabama, 35294, 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

MeSH Terms

Conditions

Brain Hemorrhage, Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dmytro Dmytriiev, MD, PhD, MBA

  Vinnytsia City Clinical Hospital named after M.I.Pirogov of Vinnitsya Regional Council

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baruch Ben Dor, PhD

CONTACT

610-608-3112; bbendor@infrascanner.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 11, 2025
• Study Start: January 17, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); UA (3)