N/A
Completed N=180
Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda
Head Trauma · Crushing Skull Injury · Head Injury · Head Injuries, Multiple
Source: ClinicalTrials.gov NCT06491173 ↗
Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Infrascanner 2500™ Diagnostic Performance — 79; 65; 27; 9 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infrascanner 2500™ Diagnostic Performance |
79; 65; 27; 9 | — |
| SECONDARY Sensitivity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™ |
89.77 | — |
| SECONDARY Specificity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™ |
29.35 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06491173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.