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NCT07014748 · ClinicalTrials.gov registry record
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
A clinical trial of Traumatic Brain Hemorrhage, sponsored by InfraScan.
- Recruiting
- Registry status
- 600
- Enrollment target
- 4
- Study locations
NCT07014748 is a study of Traumatic Brain Hemorrhage that is actively recruiting participants, run by InfraScan. The registered enrollment target is 600 participants. The trial reports 4 study locations across 2 states.
The verdict
NCT07014748, a study of Traumatic Brain Hemorrhage, is actively recruiting participants, sponsored by InfraScan.
- RECRUITING
- Registry status
- 600 participants
- Enrollment target
- 4
- Study locations
Study 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 dia
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Handheld brain hematoma detector
Study Locations (4)
Other
- Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov of Dnipropetrovsk Regional Council - Dnipro
- Ukrainian Military - Kyiv
- Vinnytsia City Clinical Hospital named after M.I.Pirogov of Vinnitsya Regional Council - Vinnytsia
Alabama
- University of Alabama in Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-01-17 |
| Est. Completion | 2026-07-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07014748
The ClinicalTrials.gov registry entry for NCT07014748 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InfraScan, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Traumatic Brain Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which Handheld brain hematoma detector is the first listed.
NCT07014748 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, Alabama.
Frequently Asked Questions
What is clinical trial NCT07014748 about?
NCT07014748 is a clinical study titled "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 K241389 approved higher laser power use to address dark skinned patients i...
What is the current status of trial NCT07014748?
This trial is currently recruiting. The enrollment target is 600 participants. The study started on 2025-01-17. Estimated completion is 2026-07-01.
What conditions does trial NCT07014748 study?
This clinical trial studies the following conditions: Traumatic Brain Hemorrhage.
What interventions are being tested in trial NCT07014748?
The interventions under investigation include: Handheld brain hematoma detector (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07014748?
This trial is sponsored by InfraScan, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07014748 being conducted?
This trial has 4 study locations across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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