CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
InfraScanner 2500™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06491173
NCT06491173N/ACompleted
CompareCT.gov

Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2500™) in Detecting Traumatic Intracranial Hemorrhage in Uganda

Duke University·interventional·Posted Jul 8, 2024·Updated Feb 25, 2026

In Brief

A clinical study evaluating InfraScanner 2500™ for Head Trauma and 15 related conditions. Completed, enrolled 180 participants across 2 sites.

Detailed Summary

The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the portable near-infrared-based device (portable NIR-based device), the InfraScanner 2500™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) or Mayanja Memorial Hospital (MMH) who have sustained or who are suspected to have sustained head trauma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead Trauma, Crushing Skull Injury, Head Injury, Head Injuries, Multiple, Head Injuries, Closed, Head Trauma,Closed, Head Injury Major, Head Injury, Minor, Head Injury, Open, Injury, Craniocerebral, Injury, Head, Multiple Head Injury, Trauma, Head, Head Trauma Injury, Head Trauma, Penetrating, Craniocerebral Injury
CountriesUganda
CollaboratorsMbarara Regional Referral Hospital, Mayanja Memorial Hospital

Timeline

N/ACompletedFinished
20252026
First PostedJul 8, 2024
Enrollment StartJul 30, 2024
Primary CompletionFeb 28, 2025
Study CompletionMar 30, 2025
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.0 years ago

Interventions

InfraScanner 2500™device

The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.