Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda

February 20, 2026 updated by: Duke University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When applicable (conscious patient and/or family or legally authorized representative is present) the study will be introduced to the patient and relevant parties prior to the research team approaching the patient. While head trauma frequently results in impaired cognition and/or consciousness, and due to the urgency of these circumstances patients are often not accompanied by kin, whenever appropriate, the purpose of the research and the procedure will be explained in detail with all questions answered to the patient's and/or representative's satisfaction. Because patients who sustain head trauma injuries typically remain within the hospital for multiple days for monitoring and care, each participant may undergo multiple Computed Tomography (CT) scans over the course of his or her hospitalization, affording the opportunity of one to numerous measurements from each patient during his or her hospital stay.

Upon presentation to the casualty unit at MRRH or MMH and following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2500™. If permission is granted, the study team member sequentially measures the optical absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and occipital bilaterally). The device is engineered such that the light emitter and receiver are spaced 4 cm apart, allowing the light's intensity to be measured between adjacent light guides. This entire procedure, including greeting and scanning the patient should take <10 minutes. Subsequent CT scan(s) the patient receives determines the number of potential data collections.

The patient and/or representative may refuse a scan during any encounter, and as such, the scan will not be done. For each patient scanned with the InfraScanner 2500™ they will be de-identified with a subject number, with age, sex, gender, skin color, hair color, hair thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT scan and near-infrared measurement. These data will be stored in de-identified form on the Research Electronic Data Capture (REDCap) database and/or Microsoft Excel on a secured network drive within the Department of Neurosurgery at Duke.

The collection period for each research subject concludes 30-days following his or her initial measurement with the InfraScanner 2500™, patient discharge, or patient death.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Mbarara, Uganda
        • Mbarara Regional Referral Hospital
      • Mbarara, Uganda
        • Mayanja Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any patient who presents to MRRH or MMH with suspected head trauma, who is able to, or who has a legally authorized representative who is able to consent in English, Swahili, or Luganda will be considered for this study.

Exclusion Criteria:

  • Patients for which wounds to their head are too large to properly use the InfraScanner 2500™ will be excluded from this study. Patients will also be excluded if hair cannot be appropriately parted to allow for the fiberoptic tips of the device to make direct contact with the scalp. Patients for whom it is not possible to obtain an Infrascan within 30 minutes of their CT imaging will also be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: InfraScanner 2500™
All patients entered into the trial will undergo at least one cranial scanning using the InfraScanner 2500™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2500™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2500™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2500™ are positive consideration of further follow-up will be given on a case-by-case basis.
Device: InfraScanner 2500™
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infrascanner 2500™ Diagnostic Performance
Time Frame: Within 30 minutes following CT scan
Number of participants with detection of intracranial hemorrhage (ICH) by the InfraScanner 2500™ stratified by CT Positive and CT Negative using the CT as the gold standard for ICH presence.
Within 30 minutes following CT scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™
Time Frame: Within 30 minutes following CT scan
The accuracy of the Infrascanner 2500™ reported through the sensitivity of intracranial hemorrhage (ICH) detection (as compared to CT findings). Sensitivity measures the ability to identify true positives.
Within 30 minutes following CT scan
Specificity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™
Time Frame: Within 30 minutes following CT scan
The accuracy of the Infrascanner 2500™ reported through the specificity of intracranial hemorrhage (ICH) detection (as compared to CT findings). Specificity measures the ability to identify true negatives.
Within 30 minutes following CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Mbarara Regional Referral Hospital
Mayanja Memorial Hospital

Investigators

  • Principal Investigator: Brad Kolls, MD, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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