Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda

NCT06491173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-02-25

Study results available

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

Interventions

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.

Sponsors & Collaborators

Mbarara Regional Referral Hospital
collaborator UNKNOWN
Mayanja Memorial Hospital
collaborator UNKNOWN
Duke University
lead OTHER

Principal Investigators

Brad Kolls, MD, PhD · Duke University

Study Design

Allocation: NA
Purpose: DIAGNOSTIC
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 12 Years
Max Age: 99 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2024-07-30
Primary Completion: 2025-02-28
Completion: 2025-03-30
FDA Device: Yes

Countries

Uganda

Study Locations

More Related Trials

Entities

Companies

Duke University