Non-Linear Imaging of Skin In Vivo: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Non-Linear Imaging of Skin In Vivo (NCT05410964), a registered phase not stated study. The primary outcome is VIO System Imaging Performance.

2. Clinical Question

3. Trial Design

NCT05410964, titled “Non-Linear Imaging of Skin In Vivo,” is a completed, single-arm device evaluation sponsored by Enspectra Health. Its official title is “Non-Linear Imaging of Skin In Vivo: VIO In Vivo Skin Imaging evaluatiON (VISION).” The registry lists enrollment of 122 and gives the study start as 2018-03-28 and primary completion as 2022-07-29. The intervention is the VIO System.

The stated objective was to investigate the system’s potential to display microscopic skin structure in people of different age, sex, race, and skin health. Imaging performance was intended to be assessed across different people, body locations, and skin conditions, including basal cell carcinoma. This scope is broader than a single uniform skin site or condition, although the registry does not report how participants or images were distributed across those categories.

The registry describes one arm, “Single Arm,” and does not state an allocation method. It does not describe randomization or a control group; the listed design is not a randomized comparison, and the arms are not a like-for-like control comparison. Thus, the study record describes device-image assessment, not a comparative estimate of performance against another system.

Device design characteristics were iterated during the study to optimize image quality across skin types, body locations, and disease states. That detail is relevant to interpretation because image performance was assessed during a period of design iteration, rather than the registry describing a single fixed device configuration throughout. The record does not report the timing or extent of those changes, a protocol for evaluating them, or whether the outcome was analyzed separately by configuration.

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

Analysis population for the primary outcome, as defined in the registry: VIO System Imaging Performance assessment was conducted on images taken of all participants

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.

6. Primary Endpoint

The registry lists the primary outcome as VIO System Imaging Performance, measured over 3 hours.

The primary endpoint is titled “VIO System Imaging Performance.” It is defined as the number of participants with acceptable images, and the registry gives a timeframe of 3 hours. The assessment drew on images taken of all participants. Engineering expert review classified imaging performance as acceptable or not acceptable, with the description emphasizing whether images were of consistent quality.

This endpoint is useful for a device evaluation because it translates the broad aim of displaying microscopic skin structure into an image-quality judgment. The registry says potential imaging dimensions could include estimated in vivo resolution and imaging depth. Those dimensions are described as possible aspects of performance; the record does not give separate numeric results for them or define a threshold for acceptable resolution, depth, or consistency.

The reported endpoint is a count of participants with acceptable images, not a direct measure of diagnostic accuracy, clinical outcomes, or benefit to patients. It also does not, by itself, show whether performance was similar across the various skin types, body locations, or disease states of interest. The registry describes the assessment process but does not report the observed count, the number of images per participant, or the criteria experts used to reach an acceptable/not acceptable judgment. Consequently, the endpoint’s intended role can be described, but its observed result and precision cannot be evaluated from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count: the number of participants whose images met the study’s acceptable-image judgment. In general, a count outcome records how many units meet a defined condition. Here, the condition was an engineering expert review of image quality, described as a judgment about whether images were of consistent quality. The record identifies the participant as the unit in the endpoint but does not explain how image-level judgments were combined when a participant had images from more than one skin location or condition.

For a count to be interpretable, the outcome definition and the set of people assessed need to be clear. The registry says the assessment was conducted on images taken of all participants and lists enrollment of 122. However, it does not report how many participants had images available for review, whether any images were excluded, or how the acceptable/not acceptable judgment was operationalized. It does not report the number of acceptable images or participants. Without the observed count and an explicit denominator for the analyzed outcome, neither an event proportion nor its precision can be assessed from the record.

In general, a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the analysis. A narrow interval indicates greater statistical precision than a wide interval, while neither width nor location alone resolves questions about measurement validity or generalizability. The registry record gives no confidence interval for imaging performance and no estimate from which one could be interpreted. It also does not report a p-value for the primary outcome. The absence of these items is not evidence that an effect was absent; it means the posted record does not quantify the result.

The outcome depends on an expert acceptability judgment. In general, explicit rating rules and information about reviewer agreement help readers assess whether such a judgment can be reproduced. The registry description says engineering experts reviewed images and determined whether they were of consistent quality. It does not report the number of reviewers, their training, any rating rubric, agreement statistics, blinding, or a procedure for resolving conflicting judgments. These are not assumptions that can be filled in from the endpoint title.

The study’s target included different skin types, body locations, and disease states. In general, variation across subgroups can be important when the measurement is intended for heterogeneous settings. An overall estimate can obscure differences between subgroups, while separate subgroup estimates can be imprecise, especially when subgroup sizes are not reported. The registry does not provide subgroup counts or results, so the consistency of performance across the intended range cannot be evaluated. The mention of possible resolution and imaging depth likewise does not establish that either was separately measured or analyzed.

The registry says device design characteristics were iterated during the study to optimize image quality. In general, changes during an evaluation can affect what version of a device is being assessed and whether results represent one stable configuration. The record does not state how many configurations were used, when changes occurred, whether assessments were compared across configurations, or which configuration the primary endpoint represents. It would therefore be inappropriate to attribute an unreported result to a specific fixed version.

The record lists a planning illustration based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also specifies that participant-based illustrations are expressed per arm, while time-to-event illustrations use a total event count. These are planning assumptions, not evidence about the design used for this single-arm evaluation. The record explicitly distinguishes the planning illustration from the trial’s own design, and it does not give a reported primary effect or a trial-specific sample-size justification. No numerical planning result is available in the record to interpret as observed power or evidence of precision.

In general, over-dispersion means that observed variation exceeds what a chosen statistical model expects; it can make model-based uncertainty too small if it is ignored. That concept is relevant when selecting methods for some count outcomes, but the registry does not report a model for this endpoint or evidence of over-dispersion. Since the primary measure is a participant count arising from acceptable/not acceptable judgments, it would also be necessary to know the assessment denominator and analysis structure before judging a model’s suitability. No such statistical analysis plan is reported in the registry record.

Finally, the registry lists 0 analyses. This means there are no posted analysis entries from which to identify model adjustment, missing-data handling, uncertainty estimation, or sensitivity analyses. It does not establish that no analyses were conducted outside the registry; it means those methods and results are not reported in the registry record. The statistical interpretation must therefore remain limited to the endpoint definition, assessment description, study design, and safety counts that are actually recorded.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures, but the record does not provide a multiplicity plan describing which analyses would be treated as confirmatory or how the chance of false-positive findings across multiple tests would be addressed. The primary outcome description mentions possible imaging dimensions such as estimated in vivo resolution and imaging depth, and it describes performance across skin types, body locations, and disease states. It does not report whether these were separate endpoints, subgroup analyses, or descriptive considerations. No subgroup results or statistical tests are posted.

Multiplicity is a general concern when several outcomes or comparisons are tested: interpreting each result in isolation can overstate the strength of evidence. No adjustment method, testing hierarchy, or prespecified analysis order is reported in the registry record. With 0 analyses listed, there is no posted set of inferential results to assess for multiplicity.

The registry does not describe missing-data handling for the primary endpoint. It says images taken of all participants were assessed, but it does not report whether any expected images or ratings were unavailable, whether any participants were excluded from assessment, or how missing image judgments would be classified. The count of participants with acceptable images is not reported, nor is an analyzed denominator identified.

The record also does not define analysis populations beyond stating that the assessment was conducted on images taken of all participants. It does not report a separate population for safety, an evaluable-image set, or rules for inclusion in the primary analysis. These details are necessary to understand which observations contributed to an estimate and how incomplete assessments were handled; they are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists one safety group, VIO Imaging. It records 122 at risk for serious adverse events and 0 affected; 122 at risk for other adverse events and 0 affected; and 0 deaths. No serious adverse-event terms are listed. These are the recorded figures for the group, not comparative estimates against a control group.

Zero recorded events means that the registry reports no events in the listed categories for this group. It does not establish that risk was absent or that the device has no safety concerns. The record does not describe how adverse events were solicited, how long participants were followed for safety, or how events were attributed. The primary endpoint timeframe of 3 hours describes imaging performance assessment; the registry does not state that this was the safety follow-up period.

Because this is a single-arm evaluation, the adverse-event figures cannot show whether event experience differed from another device or from an untreated comparison. They should be read as descriptive registry counts, not as evidence of comparative safety or a complete account of all possible harms.

12. What the Result Does, and Does Not, Mean

The study addresses a focused measurement question: whether images from the VIO System were judged acceptable by engineering experts. The registry describes an evaluation spanning different people, body locations, skin types, and skin-disease states, with image quality judged for consistency. It also states that design characteristics were iterated during the study to optimize quality. These details explain the intended scope and assessment process.

The registry does not report the primary outcome count or any statistical analysis. Therefore, it does not quantify how often images were acceptable, how precise an estimate would be, or whether acceptability differed across the intended skin categories. Without reported results, the record cannot establish the level of imaging performance achieved. The endpoint definition alone is not an outcome finding.

Even a reported acceptable-image count would answer a limited question. It would describe image acceptability under the assessment process; it would not by itself establish diagnostic accuracy, clinical usefulness, or effects on health outcomes. The record does not report a comparison with another imaging system, nor does it describe a clinical reference standard for identifying disease. The single-arm design does not support a like-for-like comparative claim.

The absence of reported subgroup results also limits conclusions about performance across different skin types, body locations, and disease states. The record does not show whether the device performed consistently across those settings. Iteration of device design is relevant context, but without configuration-specific information it is not possible to determine how changes relate to the endpoint.

The safety record reports 0 serious adverse events, 0 other adverse events, and 0 deaths in the VIO Imaging group. These counts are reassuring only in the narrow sense that no such events are recorded in those fields; they do not establish absence of risk or replace details about event monitoring and follow-up. In short, the record establishes what the investigators intended to assess and how the primary judgment was described, but it does not provide the primary result needed to judge the observed imaging performance.

13. Why This Trial Matters Statistically

This evaluation raises statistical issues that are central to device-imaging studies. First, a broad technical objective must be translated into a reproducible endpoint. The registry defines performance through engineering expert judgments of acceptable versus not acceptable image quality, then expresses the primary measure as a count of participants with acceptable images. That makes the rating process, the assessment unit, and the handling of multiple images important to interpretation. The record describes the general review but does not report the detailed rating rules.

Second, the intended use spans heterogeneous skin characteristics, body locations, and disease states. An overall result could conceal variation across those settings. Results stratified by relevant characteristics can help address consistency, but the registry does not report subgroup counts or analyses. This is a reminder that the outcome and analysis plan need to align with the breadth of the intended evaluation.

Third, device design was iterated during the study. When a device changes as image quality is being optimized, readers need to know which configurations contributed to the outcome and whether results were assessed by configuration. The record confirms iteration but does not report those details. The missing information limits the ability to connect the outcome to a stable device version.

Finally, the distinction between planning and observed evidence matters. The registry includes assumptions for a planning illustration, but labels it as separate from the trial’s own design. The study itself is listed as single arm, and no primary analysis result is posted. Planning assumptions cannot substitute for an observed endpoint estimate, its uncertainty, or a comparison. These issues make careful reporting of outcome definitions, denominators, uncertainty, subgroup findings, and analysis methods especially important for interpreting imaging-performance evaluations.

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 principal limitation of the registry record is that it does not report the primary imaging-performance result. The endpoint is described, but the count of participants with acceptable images and its denominator are not given. With 0 analyses listed, there is no posted estimate, confidence interval, or test statistic for the outcome. The record therefore cannot support a quantitative assessment of image acceptability.

The assessment description is brief. It identifies engineering expert review and a judgment about consistent image quality, but does not report the acceptance criteria, reviewer procedures, agreement, blinding, or handling of conflicting judgments. It also does not explain how multiple images from a participant were represented in the participant-level outcome. These omissions limit assessment of measurement reproducibility.

The study’s intended scope includes different people, body locations, skin types, and disease states, but the registry does not report the distribution of observations or results across these categories. It also does not provide separate findings for estimated resolution or imaging depth. This prevents evaluation of consistency across the settings named in the objective.

Device characteristics were iterated during the study, but the record does not identify configurations, change timing, or configuration-specific results. There is no like-for-like control comparison, and the record does not report diagnostic accuracy or clinical outcomes. Finally, missing-data procedures, analysis populations, and detailed safety follow-up are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Non-Linear Imaging of Skin In Vivo — NCT05410964.
• Registry record last updated 2024-01-30; status last verified 2024-01.
• Results first posted 2024-01-30.
• 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.

18. Record Summary

NCT05410964 is the completed, single-arm VIO System evaluation sponsored by Enspectra Health. Enrollment is listed as 122. The study start was 2018-03-28, and primary completion was 2022-07-29. Its objective was to investigate the potential to display microscopic skin structure across people with differing characteristics and skin health.

The primary endpoint was the number of participants with acceptable images, assessed through engineering expert review, with a stated timeframe of 3 hours. The registry says device design characteristics were iterated during the study. It does not report the primary outcome count or statistical analyses; 0 analyses are listed. The safety record reports 0 serious adverse events, 0 other adverse events, and 0 deaths in the VIO Imaging group, with 122 at risk for each listed event category.