Trial Outcomes & Findings for Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda (NCT NCT06491173)
NCT ID: NCT06491173
Last Updated: 2026-02-25
Results Overview
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.
COMPLETED
NA
180 participants
Within 30 minutes following CT scan
2026-02-25
Participant Flow
Participants were recruited from a patient population presenting with suspected head trauma at MRRH and MMH, in Mbarara, Uganda. Patients ages 13 and above, able to give consent themselves or have a legally authorized representative (LAR) who could consent in English, Runyankole, or Luganda. Criteria excluded patients for whom could not obtain complete Infrascanner 2500™ measurements within 30 minutes of their CT scan. Recruitment started July 30th, 2024 and ended February 28th, 2025.
186 consented/assessed; 6 excluded pre-assignment due to inability to obtain protocol-required CT or Infrascanner measurement (scalp/hair access or not completed within 30 min of CT), or ineligibility (post-neurosurgery in-hospital TBI, no presenting head trauma). Participants who consented but could not complete required device measurements were considered screen failures and were not assigned/enrolled. Thus 180 were assigned/enrolled.
Participant milestones
| Measure |
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 or MMH 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.
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|---|---|
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Overall Study
STARTED
|
180
|
|
Overall Study
COMPLETED
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180
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
InfraScanner 2500™
n=180 Participants
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.
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|---|---|
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Age, Continuous
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34.2 years
STANDARD_DEVIATION 13.83 • n=180 Participants
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|
Sex: Female, Male
Female
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14 Participants
n=180 Participants
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Sex: Female, Male
Male
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166 Participants
n=180 Participants
|
PRIMARY outcome
Timeframe: Within 30 minutes following CT scanPopulation: 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.
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.
Outcome measures
| Measure |
InfraScanner 2500™
n=180 Participants
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.
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|---|---|
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Infrascanner 2500™ Diagnostic Performance
True Positive
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79 Participants
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Infrascanner 2500™ Diagnostic Performance
False Positive
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65 Participants
|
|
Infrascanner 2500™ Diagnostic Performance
True Negative
|
27 Participants
|
|
Infrascanner 2500™ Diagnostic Performance
False Negative
|
9 Participants
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SECONDARY outcome
Timeframe: Within 30 minutes following CT scanThe 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.
Outcome measures
| Measure |
InfraScanner 2500™
n=180 Participants
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.
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|---|---|
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Sensitivity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™
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89.77 percentage of true positives
Interval 81.47 to 95.22
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SECONDARY outcome
Timeframe: Within 30 minutes following CT scanThe 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.
Outcome measures
| Measure |
InfraScanner 2500™
n=180 Participants
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.
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|---|---|
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Specificity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™
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29.35 percentage of true negatives
Interval 20.31 to 39.76
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Adverse Events
InfraScanner 2500™
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place