Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda

NCT06491173 | Completed Results FDA Device

• 1 other identifier: Pro00115721
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Head 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

Outcome Measures

Primary Outcomes (1)

• Infrascanner 2500™ Diagnostic Performance

  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 Outcomes (2)

• Sensitivity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™

  Within 30 minutes following CT scan

• Specificity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™

  Within 30 minutes following CT scan

Study Arms (1)

InfraScanner 2500™

EXPERIMENTAL

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™

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.

InfraScanner 2500™

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Mbarara Regional Referral Hospital: collaborator
• Mayanja Memorial Hospital: collaborator

Study Sites (2)

Mayanja Memorial Hospital

Mbarara, Uganda

Location

Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

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Related Links

• InfraScan. Infrascanner - White Paper A Handheld Brain Hematoma Detector. Accessed February 4, 2024.
• Sample size calculator . Published online 2024.

MeSH Terms

Conditions

Craniocerebral Trauma; Head Injuries, Closed; Head Injuries, Penetrating

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Wounds, Penetrating

Results Point of Contact

• Title: Bradley Kolls, MD, PhD
• Organization: Duke University

kolls001@mc.duke.edu

9196812671

Study Officials

• Brad Kolls, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 8, 2024
• Study Start: July 30, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (2)