This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas (NCT03353246), a na na study. The primary outcome is Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03353246 |
| Phase | NA |
| Condition | Head Trauma, Craniocerebral Injuries, Crushing Skull Injury |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 500 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Duke University |
| Results posted | Yes |
2. Clinical Question
Population
Patients admitted to Duke University Hospital after sustaining or being suspected of sustaining head trauma and receiving one or more brain CT scans. The registry lists an enrollment of 500. It does not report how many participants contributed to the primary endpoint analysis or whether all enrolled participants had usable device and CT data.
Intervention
InfraScanner 2000™, a handheld near-infrared light device, was used to scan participants’ heads. The study description says participants were scanned at least once within 30 minutes of CT and scanned again within 30 minutes of each subsequent CT. Participants knew their CT results but not the InfraScanner results.
Comparator
Brain CT findings define the group with hematomas for the primary sensitivity measure. This is not a randomized comparison between treatment arms: the registry describes a single-group study and lists no like-for-like control arm. The study evaluates device readings against CT findings rather than comparing clinical treatments.
Primary question
Among participants whose CT showed a hematoma of any size, what percentage had a hematoma detected by the InfraScanner at the patient level? When a participant had more than one scan, the primary endpoint uses the first scan. The registry specifies a 95% confidence interval and a timeframe of up to 30 days after the first CT scan, but the primary result is not reported in the registry record.
3. Trial Design
This is a completed, single-group pilot study sponsored by Duke University. Its stated purpose is to assess the accuracy, precision, and feasibility of the InfraScanner 2000™ for detecting subdural and epidural hematomas in patients admitted to Duke University Hospital after head trauma or suspected head trauma. Participants had received brain CT scans. The registry lists enrollment of 500, but that number does not establish how many participants were included in each outcome analysis.
The study does not use random allocation or a parallel control arm. The device is assessed in the same clinical setting as CT imaging, and CT findings are used to identify hematomas for the primary sensitivity measure. The record describes no masking. It does say that participants knew their CT results but not the InfraScanner results; that detail does not establish masking of device operators, CT readers, or outcome assessors, which is not reported in the registry record.
Participants were to undergo at least one cranial scan with the device within 30 minutes of CT, with additional device scans within 30 minutes of subsequent CT scans. For the primary patient-level outcome, the first scan was used when a participant had more than one. The primary timeframe is up to 30 days after the first CT scan. The record lists secondary outcomes for sensitivity and specificity within detection limits, including measures by hematoma type and at patient and scan levels.
The study is marked completed, with a primary completion date of 2018-05-04. Its phase and allocation are listed as not applicable. Further operational details, including site procedures beyond those described, are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | InfraScanner 2000™ |
|---|---|
| STARTED | 500 |
| COMPLETED | 500 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: For participants who had more than one scan, the first scan was used.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | InfraScanner 2000™ |
|---|---|---|
| Participants analysed | 500 | |
| Age, Continuous | years | 55.4 (SD 25.4) |
| Sex: Female, Male: Female | Participants | 211 |
| Sex: Female, Male: Male | Participants | 289 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 104 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 396 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 28 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 10 |
| Race (NIH/OMB): Black or African American | Participants | 168 |
| Race (NIH/OMB): White | Participants | 231 |
| Race (NIH/OMB): More than one race | Participants | 63 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 500 |
6. Primary Endpoint
The registry lists the primary outcome as Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level, measured over Up to 30 days after first CT scan.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the sensitivity of the InfraScanner 2000™ for detecting any-size hematoma at the patient level. The registry defines it as the percentage of participants with a hematoma detected by CT who also had a hematoma detected by the device. In statistical terms, sensitivity describes detection among those classified as having the condition by the reference method. It is not the proportion of all scanned participants with a positive device reading, nor does it by itself describe how often a positive reading is correct.
The endpoint is intended to evaluate whether the device identifies hematomas in the CT-positive group. CT serves as the reference for this outcome, while the device result is the test being assessed. The record specifies a 95% confidence interval, which would express uncertainty around the sensitivity estimate. However, neither the endpoint estimate nor its interval is reported in the registry record, so the observed sensitivity and its precision cannot be assessed from the posted results.
The analysis is at the patient level, and the first scan is used for participants with more than one scan. This rule makes the primary measure a participant-level assessment rather than treating repeat scans as separate participants. The timeframe is up to 30 days after the first CT scan. The registry does not report additional details about how CT timing, repeat imaging, indeterminate readings, or incomplete paired test results were handled in the primary analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its intended comparison, but it does not report the primary sensitivity estimate, its 95% confidence interval, or numerical findings for the listed secondary outcomes. As a result, the posted results do not establish how often the device detected CT-identified hematomas in the study population, or how precisely any estimate was measured. No conclusion about diagnostic performance can be drawn from the endpoint description alone.
The study’s stated enrollment is 500. That is a registry enrollment figure, not a reported denominator for the primary analysis. Sensitivity depends on the number of participants with CT-identified hematomas who had an assessable device result, and the record does not provide those counts. Without the estimate, its denominator, and the interval, readers cannot judge either the observed detection proportion or its uncertainty. An interval is especially important because a point estimate alone can conceal how much the result may vary due to limited information.
The primary measure concerns any-size hematoma at the patient level, while several secondary outcomes concern hematomas within detection limits, hematoma types, or scan-level performance. These are different questions and may involve different analysis populations. Results for one endpoint would not automatically answer the others. In particular, a patient-level measure using the first scan should not be interpreted as if it summarized every scan performed.
The design is single-group and nonrandomized, with CT findings serving as the reference for the primary sensitivity measure. This structure can describe agreement or detection performance in the evaluated patients, but it does not provide a randomized comparison of clinical strategies. The record does not report a complete diagnostic accuracy results set, including the numerical findings needed to assess specificity or predictive values. It also does not describe whether analysis methods accounted for repeat scans in scan-level outcomes.
The safety entries list zero serious adverse events, zero other adverse events, and zero deaths in the InfraScanner group, with 500 at risk in each listed category. These are registry entries, not a substitute for detailed safety reporting or information about completeness of event collection. The record lists no serious-event terms. The absence of reported event terms should not be stretched into a broader claim about every possible harm or about safety in other settings.
Overall, the record describes the research question, study structure, endpoint definition, and selected safety counts, but not the numerical diagnostic results. Those omissions limit interpretation: readers cannot quantify performance, its precision, or the balance of false-positive and false-negative classifications from this record.
9. Statistical Methods Explained
What does sensitivity measure?
Sensitivity is the proportion of people who have the condition according to a reference method and whose test is positive. In this study, the registry defines CT-detected hematoma as the reference classification and asks what percentage of those participants had hematoma detected by the InfraScanner. Sensitivity is conditional on being in the CT-positive group. It does not, on its own, say how frequently a positive device reading corresponds to a hematoma, and it does not measure performance among CT-negative participants. The record does not report the numerical sensitivity result.
What does the confidence interval add?
A confidence interval describes statistical uncertainty around an estimated quantity. In general, a narrower interval indicates greater precision, while a wider interval indicates more uncertainty. The registry says the primary endpoint is reported with a 95% confidence interval, but the estimate and interval are not reported in the registry record. Without them, neither the central estimate nor its precision can be evaluated. The confidence level does not mean that a particular participant’s result has a 95% probability of being correct.
Why distinguish patient-level and scan-level analysis?
A patient-level analysis treats the participant as the unit of analysis. Here, the primary outcome uses the first device scan for a participant with more than one scan. A scan-level analysis instead considers individual scans. When one participant contributes multiple scans, those observations may be related rather than independent: they come from the same person and clinical course. As a general statistical matter, treating correlated observations as independent can make uncertainty appear smaller than it is. The registry lists scan-level secondary outcomes, but the analysis method for handling repeated scans is not reported in the registry record.
Why are sensitivity, specificity, and predictive values different?
Sensitivity concerns detection among participants with a condition according to the reference method. Specificity concerns negative test results among participants without the condition according to that method. Positive and negative predictive values ask a different question: given a positive or negative device result, how often does the reference classification agree? Predictive values depend on how common the condition is in the population being tested, so they may differ across settings even when test characteristics are similar. The study summary names sensitivity, specificity, and predictive values as aims, and the outcome list includes sensitivity and specificity measures. Numerical results for these measures are not reported in the registry record.
What does a reference method establish?
Using CT findings as the reference gives the diagnostic performance measures a defined comparator. It does not establish that the reference is free of error, nor does it make the device and CT interchangeable. The registry’s primary endpoint is explicitly based on hematomas detected by CT. Details of interpretation procedures, disagreement resolution, and assessor blinding are not reported in the registry record. Those details matter because knowledge of one test result or differences in reading criteria can influence classification.
How should sample-size illustrations be understood?
Any sample-size figures associated with the analysis are planning illustrations based on an observed effect, not evidence of observed power and not the trial’s original design justification. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm. Those assumptions describe a hypothetical two-arm planning exercise, not this single-group pilot design. The original sample-size justification is not reported in the registry record, and the observed effect needed to interpret such planning illustrations is not reported.
More broadly, a design-stage sample-size calculation addresses the amount of information planned for a future study under specified assumptions. It does not demonstrate that a study had a particular probability of reaching a statistical conclusion after it was completed. The registry record does not report a prespecified statistical analysis plan, methods for estimating the primary confidence interval, or any inferential tests for the diagnostic outcomes. Accordingly, no unreported analysis procedure should be assumed.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary sensitivity outcome and multiple secondary outcomes. Those secondary measures cover sensitivity and specificity within detection limits, performance by hematoma type, false-negative values, and both patient-level and scan-level assessments. Examining multiple outcomes creates several opportunities to find a result that appears notable by chance. Statistical approaches to address that issue can include prespecifying a primary outcome, adjusting inference across a defined family of tests, or treating secondary results as exploratory. Which approach was used is not reported in the registry record.
The primary endpoint is described with a 95% confidence interval, but the registry does not report the numerical estimate or interval. It also does not report a multiplicity adjustment, a hierarchy for secondary endpoints, or a statistical analysis plan. Without those details and the outcome results, the strength of evidence across the full set of measures cannot be assessed. The listed outcomes should not be treated as interchangeable or as multiple confirmations of a single finding.
Missing-data handling is not reported in the registry record. In a diagnostic assessment, participants may lack paired device and CT readings, or a reading may be indeterminate or technically unsuccessful. The record does not say how such cases were classified, excluded, or included in each analysis. It also does not report the numbers of participants or scans contributing to the endpoint denominators. The enrollment figure alone cannot answer those questions.
The record does not describe analysis populations, such as whether the primary analysis included all enrolled participants, only those with paired evaluable results, or another defined group. It also does not report whether scans after the first were excluded from all patient-level analyses, beyond the stated first-scan rule for the primary outcome. These omissions limit assessment of potential bias from missing readings, exclusions, or repeated observations.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| InfraScanner 2000™ | 0 | 500 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| InfraScanner 2000™ | 0 of 500 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| InfraScanner 2000™ | 0 of 500 |
The registry lists the InfraScanner 2000™ group with 500 participants at risk in the serious adverse event category and zero affected. It also lists 500 at risk and zero affected in the other adverse event category, with zero deaths. No serious adverse-event terms are listed. These figures describe what the registry record reports for this group; they do not provide event narratives, severity details, timing, or a description of how events were collected.
A zero count in a registry entry is not evidence that every possible harm was ruled out. Interpretation depends on the duration and completeness of follow-up, the event definitions, and the method of ascertainment. Those details are not reported in the registry record. Nor does the record describe a comparison group that would allow a comparative safety estimate. The study’s single-group design is not a randomized safety comparison, and the listed counts should not be used to infer relative risk.
The entry for participants at risk is not necessarily the analysis denominator for any diagnostic endpoint, and the record does not clarify the relationship between those safety counts and the number with evaluable device and CT results. The figures therefore support a limited reading: the registry lists no affected participants in these adverse-event categories, but the surrounding information needed to assess event ascertainment and safety precision is not reported.
12. What the Result Does, and Does Not, Mean
The study asks a clinically relevant diagnostic question: whether a handheld near-infrared device detects hematomas identified by CT in hospitalized patients with head trauma or suspected head trauma. The registry defines a patient-level primary sensitivity measure and specifies use of the first scan for participants scanned more than once. It also identifies secondary questions involving specificity, hematoma type, detection limits, and scan-level performance.
Those definitions clarify what the investigators intended to measure, but they are not numerical findings. The primary sensitivity estimate and its 95% confidence interval are not reported in the registry record. Numerical secondary outcome results, including specificity and predictive values, are also not reported. Therefore, the posted results do not show the device’s observed detection rate, the uncertainty around that rate, or the frequency of false-positive classifications.
Even if diagnostic estimates were available, their interpretation would depend on the study population, the definition and reading of CT findings, the handling of missing or indeterminate readings, and the way repeat scans were analyzed. The registry describes a hospital-based group with CT imaging and a single-group design; it does not establish performance in other populations or care settings. The record also does not describe a randomized comparison of diagnostic strategies or patient outcomes.
The safety entries report zero serious adverse events, zero other adverse events, and zero deaths in the listed group, but do not provide detailed ascertainment information. Those entries should be read as recorded counts, not as proof that no risk exists. Overall, the registry supports understanding the study question and its planned measures, while leaving the core diagnostic performance results and important analysis details unavailable.
13. Why This Trial Matters Statistically
This study is statistically notable for assessing a diagnostic device against CT findings in a single-group clinical setting, rather than comparing treatments through randomized allocation. That design makes the distinction between the test being evaluated and the reference classification central to interpretation. The primary outcome is sensitivity among participants with CT-detected hematomas, not a general measure of how often the device result is correct across all participants.
The registry also distinguishes patient-level from scan-level outcomes. This matters because repeated observations from one participant are not equivalent to observations from unrelated participants. The primary endpoint’s first-scan rule gives a defined participant-level measure, while scan-level secondary measures raise questions about dependence between repeated scans. The record does not describe the method used to handle that dependence.
Statistical precision is another key issue. A sensitivity estimate without its denominator and confidence interval would provide an incomplete account of the evidence. The registry specifies a 95% confidence interval but does not report the interval or estimate. Nor does it provide numerical results for the listed secondary diagnostic measures. The intended statistical questions are therefore identifiable, but their answers cannot be evaluated from the posted results.
Finally, the study’s pilot designation and its stated focus on accuracy, precision, and feasibility make clear why outcome definitions and reporting detail matter. A transparent account of evaluable participants, device failures or indeterminate readings, CT classifications, and analysis methods would help readers judge what the observed data can support. Such details are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation for interpreting this record is that numerical diagnostic results are not reported. The primary sensitivity estimate and its 95% confidence interval are absent, as are the numerical results for the listed secondary outcomes. The record therefore does not allow readers to assess observed accuracy or statistical precision.
The enrollment figure of 500 does not identify the denominator used for the primary analysis. The registry does not report how many participants had CT-detected hematomas, how many had paired and evaluable device readings, or how many were included in each secondary analysis. It also does not explain the handling of missing, indeterminate, or technically unsuccessful readings. These details are necessary to understand which participants contributed to each estimate.
The study is single-group and nonrandomized, so it does not supply a randomized control comparison. The primary endpoint uses CT findings as the reference, but procedures for CT interpretation, device reading, and resolving disagreement are not described in the registry record. Although participants knew their CT results but not their InfraScanner results, assessor masking is not reported.
The record lists both patient-level and scan-level outcomes, but does not describe the analysis method for repeat scans in scan-level measures. The statistical analysis plan, multiplicity strategy, and analysis populations are also not reported. Finally, the registry safety entries lack event-collection and follow-up details, limiting interpretation of the zero counts. These are limitations of what can be established from the registry record, not evidence that a particular method was or was not used.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas — NCT03353246.
- Registry record last updated 2019-08-20; status last verified 2019-04.
- Results first posted 2019-05-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03353246 is a completed single-group pilot study sponsored by Duke University. It assessed the InfraScanner 2000™ for detecting subdural and epidural hematomas in patients admitted to Duke University Hospital after head trauma or suspected head trauma and receiving brain CT scans. The registry lists enrollment of 500 and describes device scans within 30 minutes of CT.
The primary outcome is patient-level sensitivity for any-size hematoma, using CT findings as the reference and the first scan when a participant had more than one. The record specifies a 95% confidence interval and a timeframe of up to 30 days after the first CT scan. Numerical primary and secondary diagnostic results are not reported in the registry record. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths in the InfraScanner group, but event-ascertainment details are not reported.