Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts (NCT05787782), a na na study. The primary outcome is Accuracy of Temperature Measurements Using Masimo INVSENSOR00063.

2. Clinical Question

This is a measurement-validation question, not a question about the effect of a treatment. The device readings are intended to be compared with reference readings over a timeframe of about 15-30 minutes. The registry record does not state the reference thermometer’s make or model, nor does it explain whether all participants were assessed while febrile, afebrile or in both conditions. The title refers to both febrile and afebrile subjects, but the record does not give results separately by fever status.

The distinction between the device and its reference is important: a reference reading provides a basis for evaluating the device’s agreement, but it is not a randomized control arm. The record describes a single-group, non-randomized data collection study. It therefore addresses whether device measurements agree with reference measurements under the study’s measurement conditions, rather than whether the device changes a clinical outcome.

3. Trial Design

The registry describes a prospective, non-randomized data collection study of the Masimo INVSENSOR00063. Enrollment was 60, and all subjects were assigned to the single device arm. Allocation is listed as NA, and masking is listed as none. The record describes temperature measurements being obtained with the device and compared with reference temperature measurements.

The study is marked completed. Its recorded start date is 2023-02-23, and its primary completion date is 2023-03-02. The sponsor is Masimo Corporation. The phase is listed as NA. These administrative details describe how the record classifies the study; they do not provide evidence about the accuracy of the device.

The primary outcome is titled “Accuracy of Temperature Measurements Using Masimo INVSENSOR00063.” Its timeframe is about 15-30 minutes. The description names clinical bias, limits of agreement and repeatability as the measures used to assess accuracy. The record lists one outcome measure and zero analyses, but it does not include numerical endpoint results, estimates of agreement, confidence intervals or test results.

Two subject-level exclusions are described in the outcome population text. Data for 1 subject was excluded because the subject did not complete one round of measurements. Data for 1 subject was also excluded because the data suggested external conditions interfered with the reference clinical thermometer or device measurements. The record does not clarify whether these descriptions refer to distinct people or whether the excluded data were handled in any other way.

This design can support assessment of measurement agreement within the conditions under which readings were taken. It does not offer a randomized, like-for-like control comparison, and the reference readings should not be mistaken for a separately assigned control arm. The record does not report further protocol details, such as the specific measurement sequence or any prespecified acceptance criteria.

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: Data for 1 subject was excluded as they did not complete one round of measurements. Data for 1 subject was excluded as the data suggested existence of external conditions that interefere with RCT (reference clinical thermometer) or Masimo INVSENSOR00063 measurements.

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 Accuracy of Temperature Measurements Using Masimo INVSENSOR00063, measured over About 15-30 minutes.

The primary endpoint concerns the accuracy of temperature measurements obtained with the Masimo INVSENSOR00063 relative to reference temperature measurements. The unit is degrees Celsius, and the registry names clinical bias, limits of agreement and repeatability as the assessment measures. The measurement timeframe is about 15-30 minutes. Numerical results for the endpoint are not reported in the registry record.

In general, clinical bias describes the average direction and size of differences between a device and its reference. A small average bias alone does not guarantee that individual readings are close to the reference: limits of agreement are used to describe the range in which differences between paired measurements may lie. Repeatability concerns how consistent repeated readings are under comparable conditions. Considering these features together gives a more informative view of measurement performance than relying on average bias alone.

These are general interpretations of the named statistical concepts, not claims about the findings of this study. The registry record does not give the observed bias, limits of agreement, repeatability estimate, uncertainty intervals or criteria for judging an estimate acceptable. As a result, the endpoint definition can be described, but the posted results do not allow a quantitative assessment of how closely the device measurements matched the reference measurements.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measurement question is agreement between device readings and reference readings. In general, agreement analysis asks how close paired measurements are, rather than whether two groups differ on average. The registry record names three related concepts: clinical bias, limits of agreement and repeatability. It does not provide the formulas, analysis specifications or numerical estimates used in this study, so the explanations below describe the concepts generally rather than reconstructing the study’s calculations.

What does bias describe?

In general, bias is the average difference between measurements made by the device and measurements made by the reference. Its direction indicates whether the device tends to read higher or lower, while its magnitude describes the average offset. A reported average should be interpreted alongside the variation among individual paired readings: an average near zero can coexist with substantial discrepancies for some measurements. The registry record does not report the study’s bias estimate or its direction.

Why are limits of agreement useful?

In general, limits of agreement describe the spread of differences between paired measurements. They help readers understand how far an individual device reading might differ from its reference, rather than describing only the average offset. Their interpretation depends on the observed differences and on the measurement context. The registry record does not provide the limits, their uncertainty or a threshold for acceptable agreement, so their practical implications cannot be assessed from the posted results.

What does repeatability assess?

In general, repeatability concerns the consistency of repeated measurements under comparable conditions. A device may have little average bias yet produce readings that vary from one measurement to another; repeatability helps address that distinct aspect of measurement quality. The record names repeatability as part of the accuracy assessment but does not state the specific repeatability procedure or report an estimate. It is therefore not possible to determine how repeated readings behaved.

How should the reference comparison be understood?

For this study, the reference temperature measurements serve as the comparator for evaluating device measurements. This is a paired measurement comparison, not a randomized trial contrast between separate groups. In general, the quality and description of the reference method matter because conclusions about agreement are conditional on the reference used and the measurement conditions. The registry record does not identify the reference thermometer’s make or model or provide a detailed account of measurement procedures.

The timeframe for the outcome is about 15-30 minutes. That indicates the time period associated with the measurement assessment, but it does not, by itself, specify the order, timing or number of measurements. Those procedural details are not reported in the registry record. The record also does not state an acceptance margin or a decision rule for interpreting the observed agreement.

What can statistical uncertainty tell readers?

In general, a confidence interval describes the uncertainty around an estimate under the assumptions of the statistical method used. Narrower intervals indicate greater precision for that estimate, while wider intervals indicate less precision. An interval around bias would describe uncertainty in the average difference; intervals around agreement limits would help show how precisely those limits were estimated. No confidence intervals are reported for the primary endpoint in the registry record.

The registry lists one outcome measure and zero analyses. That does not supply enough detail to reproduce an analysis or assess its assumptions. The statistical plan, including any exact estimation method, handling of repeated observations and approach to uncertainty, is not reported in the registry record. It would be inappropriate to infer those methods from the endpoint labels alone.

How do the planning illustrations differ from observed results?

In general, a sample-size calculation describes a hypothetical design and the number of participants it might require under stated assumptions. It is not a finding about the measurements collected. The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation and an effect defined as a fraction of the observed effect. These assumptions do not match the registry’s description of a single-group device-validation study. The illustration is not observed power, and it cannot be read as a result of the study.

The record does not report the numerical endpoint effect on which the illustration is said to be based. Nor does it report the justification for the enrolled sample size or a protocol-specific sample-size calculation. Therefore, the illustration cannot be used to infer the precision of the device accuracy estimates or the adequacy of the completed study for a particular agreement target.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure, focused on accuracy of temperature measurements. It does not report a multiplicity adjustment or explain whether additional outcomes were considered in the study protocol. With no numerical analyses posted, it is not possible to assess how multiple statistical tests or estimates were handled. A multiplicity method is not reported in the registry record.

The outcome description states that data for 1 subject was excluded because the subject did not complete one round of measurements. It separately states that data for 1 subject was excluded because conditions appeared to interfere with measurements from the reference clinical thermometer or the Masimo INVSENSOR00063. The record does not clarify whether the exclusions involve the same or different participants, whether any other observations were missing, or how the exclusions were treated in the analyses.

The analysis population is not reported in the registry record. Although enrollment was 60, the record does not give the number of participants or paired readings included in each endpoint calculation. It also does not describe an imputation procedure, a missing-data sensitivity analysis or a prespecified rule for incomplete measurements. These omissions limit assessment of whether the posted endpoint, if reported, would represent all enrolled participants or a subset with usable measurements.

The statistical analysis plan and the handling of repeated readings are not reported in the registry record. Without those details or endpoint estimates, readers cannot assess the consequences of missing measurements, exclusions or analytic choices for the accuracy findings.

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 60 subjects at risk for serious adverse events and reports 0 subjects affected. It also lists 60 at risk in the other adverse-event category and reports 0 affected. The deaths entry is 0, and no top serious adverse-event terms are listed. These are the recorded safety figures for the Masimo INVSENSOR00063 group.

These entries describe what was reported in the registry; they do not establish that no adverse events occurred outside the recorded definitions or observation period. The record does not provide further details about safety-event collection, the observation period, event definitions or whether events were assessed as related to the device. The zero counts should therefore be read as zero reported affected subjects in the registry entries, not as proof that risk was absent.

Because this is a single-group study, the safety figures do not provide a comparative estimate against a control group. They also do not address temperature-measurement accuracy, which is the primary outcome. The reported safety counts and the measurement endpoint answer different questions and should be interpreted separately.

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

The registry record describes a study intended to evaluate how closely Masimo INVSENSOR00063 temperature measurements agree with reference measurements. The specified statistical concepts—clinical bias, limits of agreement and repeatability—address different aspects of measurement performance. However, the record does not report numerical findings for these measures. It therefore does not show the magnitude or precision of agreement between the device and the reference.

The study’s title mentions febrile and afebrile subjects, but the record does not report separate participant counts or endpoint results for those conditions. It also does not describe an assigned control group: the reference measurements are a measurement comparator, not a randomized intervention. The findings, even if numerical results were available, would concern agreement in the study’s measurement setting rather than a treatment effect or a clinical outcome.

The record does not provide a performance threshold or acceptance criterion. Without such criteria and the observed estimates, readers cannot determine from the registry information whether the measured agreement met a particular standard. The posted information also does not provide enough detail to assess the effects of the subject-level exclusions or determine how many measurements contributed to analysis.

The completed status, enrollment and safety entries are useful descriptions of the registered study, but they cannot replace the missing endpoint results. The reported 0 adverse-event counts do not establish measurement accuracy, and the planning assumptions do not constitute observed evidence. The registry record supports a description of the study question and design; it does not support a quantitative conclusion about device performance.

13. Why This Trial Matters Statistically

Measurement studies raise a statistical question that differs from the usual comparison of clinical outcomes: whether readings from a device are sufficiently close to a reference for the intended measurement context. Reporting average bias alone may not describe how much individual readings vary. Limits of agreement and repeatability address complementary features, which is why the registry’s stated endpoint includes all three concepts.

This record also illustrates the importance of distinguishing a reference measurement from a control arm. A reference provides a benchmark for paired measurements; it does not create a randomized comparison between groups. Interpreting the design correctly prevents an agreement study from being described as a treatment trial or its estimates from being treated as causal effects.

Transparent reporting is essential to making a measurement-validation study interpretable. Readers need the endpoint estimates, uncertainty, measurement procedures, analysis population and criteria used to judge agreement. In this registry record, the accuracy outcome is defined, but numerical results and analysis details are not reported. The study’s design and question can therefore be identified, while its statistical findings cannot be evaluated quantitatively.

The exclusions also show why enrollment alone does not fully describe the data available for analysis. The record identifies incomplete measurement data and possible external interference, but does not explain their overlap or analytic handling. Reporting these details alongside endpoint estimates would help readers understand how the collected measurements support the conclusions.

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 main limitation for interpreting this study is that the registry record does not report numerical results for the primary accuracy endpoint. It names bias, limits of agreement and repeatability but gives no estimates, uncertainty intervals or results by fever status. Consequently, the agreement of the device with reference measurements cannot be quantified from the record.

The record does not describe the reference thermometer beyond calling it a reference clinical thermometer. It also does not report detailed measurement procedures, repeat-reading structure, an acceptance criterion or the statistical methods used. These details are important for understanding what agreement means in the study’s particular setting and how precisely it was estimated.

The outcome population text reports exclusions related to incomplete measurement and possible external interference. The record does not clarify whether the excluded data refer to distinct participants, how many paired readings remained, or how exclusions were reflected in the analysis. Enrollment of 60 therefore does not reveal the endpoint’s analysis population.

The title refers to febrile and afebrile subjects, but no allocation or results by fever status are reported. The single-group, non-randomized design also does not provide a randomized control comparison. Finally, the registry does not report the statistical analysis plan, missing-data approach or sample-size justification. These limits are specific to the information available in the record and prevent a full assessment of the study’s numerical findings or precision.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts — NCT05787782.
• Registry record last updated 2025-10-31; status last verified 2023-06.
• Results first posted 2023-07-10.
• 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

NCT05787782 is a completed, prospective, non-randomized data collection study sponsored by Masimo Corporation. It evaluates the Masimo INVSENSOR00063 for obtaining temperature measurements, with reference temperature measurements used for comparison. Enrollment was 60; all subjects were enrolled in one device arm. The record lists the study phase as NA, allocation as NA and masking as none.

The primary outcome is accuracy of temperature measurements in degrees Celsius, assessed using clinical bias, limits of agreement and repeatability over about 15-30 minutes. The record lists one outcome measure and zero analyses. Numerical accuracy results are not reported in the registry record. It reports 0 subjects affected by serious adverse events among 60 at risk, 0 in the other adverse-event category among 60 at risk, and 0 deaths.

The study start date is 2023-02-23, and the primary completion date is 2023-03-02. The record describes exclusions related to incomplete measurements and possible external interference but does not give a final analysis population or numerical endpoint findings.