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 Clinical Performance of Masimo INVSENSOR00048 (DALI0001) (NCT06922461), a na phase not stated study. The primary outcome is Primary Outcome.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06922461 |
| Phase | Phase not stated |
| Condition | Temperature |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Masimo Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The registry lists the condition as Temperature and reports enrollment of 4 participants. It does not provide further detail about participant characteristics, eligibility criteria, or the intended reference body site. The outcome description says subjects were excluded from analysis because they lacked a minimum of three reference readings or observations; the wording in that part of the record is truncated, so the precise nature of the required reference data is not fully clear.
Intervention
All participants were assigned to the test group and fitted with the non-invasive investigational Masimo INVSENSOR00048 sensor for body temperature measurements. The intervention is listed as a device. No additional details about sensor placement, adjustment settings, or measurement procedures are reported in the registry record.
Comparator
The planned reference was a reference thermometer. The primary outcome description calls for comparison of the device-under-test temperature in its corresponding adjustment mode with reference thermometer readings. This was not a randomized, parallel-group comparison: the record lists a single group and no allocation. Further details about the reference thermometer or its use are not reported.
Primary question
The study aimed to determine temperature performance by evaluating clinical bias and limits of agreement between the investigational sensor and the reference thermometer over approximately 90 minutes. In general, bias describes the average difference between paired measurement methods, while limits of agreement describe the spread of their differences. The registry states that early termination and insufficient sample size prevented statistical comparison with reference values, so the intended performance assessment could not be computed.
3. Trial Design
The registry describes a single-group device study of the Masimo INVSENSOR00048, with all enrolled participants fitted with the investigational sensor. It lists no allocation and no masking. The record therefore does not describe a randomized comparison or a separate control group; the planned comparison was between the device’s measurements and readings from a reference thermometer.
Enrollment was 4. The study start date is 2025-05-02, and the primary completion date is 2025-05-22. Its status is listed as terminated. The record says the study was terminated early and that the sample size was insufficient to compare collected data statistically with reference values. The reason for termination is not reported in the registry record.
The planned primary outcome was temperature performance, assessed through clinical bias and limits of agreement for device and reference readings. The timeframe is approximately 90 minutes. This describes the intended measurement period, not evidence that complete paired observations were available for every participant. The record says subjects were excluded from analysis because they did not meet a minimum of three reference readings or observations, although the associated wording is truncated. The number of participants with usable measurements and the details of the analysis population are not reported.
The registry lists one outcome measure and no analyses. It does not report a statistical analysis plan, a sample-size justification, interim analyses, or a reason for early termination beyond stating that the study ended early and the sample was insufficient. With no completed analysis of the primary outcome, this design record documents the question and measurement approach but cannot establish an estimate of device-reference agreement.
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 | INVSENSOR00048 |
|---|---|
| STARTED | 4 |
| COMPLETED | 4 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was terminated early and the sample size was insufficient to statistically compare data collected to the reference values. Hence, the clinical performance of the Masimo INVSENSOR00048 could not be computed. Subjects were excluded from analysis due toa lack of a minimum of three (3) reference measurement groups , data that suggests a defective device or sensor , or data that suggests the existence of external conditions that interfere with DUT measurements or reference 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.
| Characteristic | Unit | INVSENSOR00048 |
|---|---|---|
| Participants analysed | 4 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 3 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 2 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Primary Outcome, measured over Approximately 90 minutes.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Degrees Celsius |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is described as temperature performance of the Masimo INVSENSOR00048. It was intended to compare the device-under-test temperature in the corresponding adjustment mode with a reference thermometer over approximately 90 minutes. The specified measures are clinical bias and limits of agreement, expressed in degrees Celsius.
Clinical bias is defined in the registry as the mean difference between output temperatures from a clinical thermometer and a reference clinical thermometer for the intended reference body site. In general, the mean difference indicates whether one measurement method tends to read higher or lower than the other. It does not, by itself, show how widely individual paired readings differ.
The registry defines limits of agreement as the magnitude of potential disagreement between two clinical thermometers, equal to double the standard deviation of their temperature differences when used on the same subject. In general, these limits describe the spread of paired differences and help characterize how closely two measurement methods agree across observations. Their interpretation depends on having enough suitable paired measurements and on the assumptions used to describe the distribution of differences.
These measures were selected to assess agreement with a reference method, rather than to compare clinical outcomes between treatment groups. However, the registry states that the sample was insufficient for statistical comparison with reference values and that clinical performance could not be computed. It reports no bias estimate, limits of agreement, or uncertainty estimates.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record describes an intended measurement-agreement study, not a trial comparing two treatment groups. Four participants enrolled in the single test group, and the study status is terminated. The registry explicitly states that early termination left an insufficient sample for statistical comparison with reference values. It also says that clinical performance could not be computed. As a result, there is no reported numerical estimate of clinical bias or limits of agreement to interpret.
This absence of an estimate is not evidence that the investigational sensor agrees well or poorly with the reference thermometer. Agreement cannot be judged from the stated objective alone. The record does not report the paired temperature readings, the number of usable pairs, a mean difference, a standard deviation of differences, limits of agreement, or confidence intervals. It also does not provide a formal test result or a p-value for the primary outcome. These quantities are not reported in the registry record.
In general, a mean bias estimate addresses average directional difference, while limits of agreement describe the spread of differences that could occur across paired measurements under the studied conditions. Both are needed to understand agreement: a small average difference can coexist with substantial variation among individual pairs. Confidence intervals, when reported, express uncertainty around estimates; they do not replace the estimates themselves. None are available for this outcome in the record.
The study’s small enrollment and early termination are important context because the registry itself identifies the sample as insufficient for the intended statistical comparison. No effect-size estimate can be recovered from the enrollment count or from the endpoint definition. Nor should planning illustrations be interpreted as observed statistical power or as evidence that a particular result was detected: the primary outcome was not computed.
The record includes safety counts for the test group, but those counts answer a different question from measurement agreement. They do not fill the gap in the primary performance analysis. Likewise, the listed measurement timeframe does not establish that the planned measurement series was completed. The number and completeness of paired observations are not reported.
Overall, the registry documents the objective, the single-group design, and the reason the intended comparison was unavailable. It does not provide evidence from which the magnitude or precision of device-reference agreement can be assessed. The appropriate statistical conclusion is therefore limited: the planned performance analysis could not be computed from the study data described in the record.
9. Statistical Methods Explained
The statistical target in this study was agreement between two temperature measurement methods: the INVSENSOR00048 and a reference thermometer. This is distinct from a randomized treatment comparison. There was one group of participants, and the intended statistical information would come from paired readings taken under the study’s measurement conditions. The record does not describe a treatment-control contrast or a between-group hypothesis test.
What clinical bias describes
In general, a paired difference is formed by comparing the two methods’ readings for the same measurement occasion. The mean of those differences is the bias. Its sign and magnitude can indicate average directional disagreement, depending on the subtraction convention. The registry defines clinical bias as the mean difference between the clinical thermometer output and the reference clinical thermometer output for the intended reference body site. It does not specify the subtraction order in the result fields, and no estimate is reported.
A mean difference is an average, so it does not describe every paired reading. In general, differences can vary around the average: some may be closer to zero and others farther away. A mean bias near zero would not alone establish that individual readings are close, because positive and negative differences can offset each other. No such numerical pattern can be assessed for this study because the record says clinical performance could not be computed.
What limits of agreement describe
The registry defines limits of agreement using double the standard deviation of the output temperature differences. In general, the standard deviation describes the dispersion of paired differences around their mean. Limits based on that dispersion are intended to characterize the range of disagreement expected for individual paired measurements, subject to the method’s assumptions. They complement bias: bias addresses the average difference, whereas the limits address how variable the differences are.
Interpretation of limits of agreement generally depends on the distribution of paired differences and on whether observations are appropriately paired and representative of the conditions of interest. Repeated observations from the same participant can also be related rather than independent. The registry does not report how repeated readings were handled, whether distributional assumptions were assessed, or whether any adjustment for within-participant dependence was used. Those methodological details are not reported in the registry record.
Why the missing estimate matters
Agreement analysis requires usable paired measurements. The registry says subjects were excluded from analysis because of a lack of a minimum of three reference readings or observations, but the text describing this requirement is truncated. It also says that the sample size was insufficient to compare the collected data statistically with reference values. The record does not state how many paired observations remained, how many participants contributed to any calculation, or whether any partial calculations were attempted.
Without the paired data or reported summary statistics, bias and limits of agreement cannot be independently reconstructed. No standard error, confidence interval, or p-value is reported. In general, a confidence interval conveys uncertainty around an estimate, while a hypothesis-test p-value addresses compatibility with a specified null model. Neither can substitute for the absent agreement estimates, and neither is available for the primary outcome in the registry record.
Planning calculations and observed evidence
In general, sample-size planning calculations depend on assumptions about the target effect, variability, significance level, allocation, and analysis method. Such calculations are prospective illustrations, not evidence about what a study observed. The registry record does not report the protocol’s sample-size justification or the assumptions used to set enrollment. Any planning illustration should therefore be read separately from the study’s observed results and cannot supply an outcome estimate where none was computed.
The record does not report interim analyses, a prespecified statistical analysis plan, adjustment procedures, or rules for handling missing observations beyond the stated exclusion reason. It lists one outcome measure and no analyses. Consequently, the available methodological description supports only a limited account: the intended analysis was based on clinical bias and limits of agreement between device and reference temperatures, but the planned statistical comparison was not completed or reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, titled “Primary Outcome,” and reports no analyses. It does not describe a family of statistical tests, secondary endpoint testing, multiplicity adjustment, or a hierarchy for interpreting multiple results. Whether any additional outcomes were collected but not entered in the record is not reported in the registry record. With no primary outcome estimate reported, there are no posted p-values whose interpretation would depend on adjustment for multiple testing.
Missing-data information is limited. The primary outcome description says that subjects were excluded from analysis because they lacked a minimum of three reference readings or observations. The wording is truncated after the reference requirement, so the exact eligibility condition is not fully recoverable. The record does not report the number excluded, the number with complete paired measurements, the reasons for any other unavailable readings, or a method for handling missing data.
The analysis population is also not specified beyond the statement that subjects were excluded. The registry does not state whether the intended analysis used all enrolled participants, only those meeting measurement requirements, or another defined population. It gives no participant-level flow information or accounting of measurements. These omissions prevent assessment of whether the analyzed data, had an analysis been completed, would represent all enrolled participants or a selected subset.
In general, exclusions and missing measurements can affect an agreement analysis if the availability of paired readings is related to the readings themselves or to study conditions. The record does not provide information to evaluate that possibility. No imputation method, sensitivity analysis, or missingness assumption is reported. The safe interpretation is that the planned analysis was not available and the handling of incomplete data is insufficiently described.
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 |
|---|---|---|---|
| INVSENSOR00048 | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| INVSENSOR00048 | 0 of 4 |
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 |
|---|---|
| INVSENSOR00048 | 0 of 4 |
The registry reports serious adverse events for the INVSENSOR00048 group with 4 participants at risk and 0 affected. It also reports other adverse events with 4 at risk and 0 affected, and deaths with 0 reported. These are the safety counts recorded for the study group.
In general, a zero count means that the registry reports no events in the specified category among the participants listed as at risk; it does not establish that no event could occur, or that all possible events were captured. The record does not provide event-term detail because no serious-event terms are listed. It also does not report further detail on safety monitoring, event collection procedures, or the observation time used for these counts.
These figures should be read separately from the primary temperature-performance question. They do not show whether the sensor’s readings agreed with the reference thermometer. The study was terminated, and the primary statistical comparison could not be computed. The safety counts therefore describe reported events in a small enrolled group, not a comparative safety estimate or a complete assessment of risk.
12. What the Result Does, and Does Not, Mean
The record establishes that a clinical study was registered to evaluate temperature performance of the Masimo INVSENSOR00048 by comparison with a reference thermometer. All participants were assigned to the test group, enrollment was 4, and the study was terminated. The registry states that the early termination and insufficient sample size prevented statistical comparison with reference values, so clinical performance could not be computed.
That means the posted information does not quantify average bias or the spread of paired temperature differences. It does not support a conclusion about the degree of agreement between the device and reference thermometer, either favorable or unfavorable. The absence of reported estimates is not a result showing equivalence, nor is it a result showing disagreement. The measurement question remains unanswered by the statistical results in this record.
In general, a device-reference agreement assessment needs more than a study objective or an enrollment total. It needs usable paired readings and reported summaries that characterize average difference and variability, together with sufficient information to understand their precision and analysis assumptions. The registry does not provide those data or estimates. It also does not report confidence intervals, a primary-outcome p-value, or the number of paired observations available.
The safety entries show 0 serious adverse events among 4 at risk, 0 other adverse events among 4 at risk, and 0 deaths. These counts describe what was entered for this group; they do not answer the performance question or establish a broader safety profile.
The result should therefore be interpreted as an incomplete statistical assessment, rather than as a positive or negative finding about measurement performance. The record is informative about the intended endpoint and the stated reason a comparison was not possible, but it does not provide an estimate from which the magnitude or precision of agreement can be judged.
13. Why This Trial Matters Statistically
This study illustrates a central issue in measurement research: a clearly stated performance objective does not itself produce an interpretable estimate. The registry identifies clinical bias and limits of agreement as the intended measures, which address complementary aspects of device-reference differences. Yet it also states that clinical performance could not be computed because the study ended early and the sample was insufficient for comparison with reference values.
Statistically, the distinction between planned and observed evidence is important. Enrollment of 4 is a description of participation, not a measurement-agreement result. A planned measurement timeframe of approximately 90 minutes likewise does not establish that complete paired readings were available. Without reported estimates and their uncertainty, readers cannot judge either average difference or the variability of differences.
The record also demonstrates why completeness of paired data matters. The outcome description cites a minimum reference-data requirement for analysis and says subjects were excluded, but the text is truncated and the numbers of usable observations are not reported. When the analysis population and data availability are unclear, it is difficult to determine how the intended analysis would have represented enrolled participants.
Finally, this record separates safety reporting from performance analysis. The absence of reported adverse events in the listed categories does not resolve whether the device measurements agreed with the reference method. For statisticians and clinical researchers, the key lesson is to distinguish the study question, the planned estimands, the data available for analysis, and the results actually reported. In this record, the question is specified, but the performance estimate is unavailable.
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 consequential limitation is that the registry reports no computed primary performance result. Although the intended measures are clinical bias and limits of agreement, neither an estimate nor its uncertainty is reported. The record explicitly attributes the unavailable comparison to early termination and an insufficient sample size. Therefore, the magnitude and precision of agreement cannot be assessed.
Enrollment was 4, and the study is listed as terminated. The registry does not give the reason for termination, a detailed participant flow, or the number of participants with usable paired readings. It notes exclusions associated with a minimum of three reference readings or observations, but the description is truncated. The specific data requirement and the number of affected participants are consequently unclear.
Measurement details are limited. The record names a reference thermometer and refers to the device’s corresponding adjustment mode, but it does not report the reference instrument’s characteristics, the adjustment settings, the measurement site, or procedures for collecting and pairing readings. These details are not reported in the registry record. The record also does not state how repeated observations were handled or identify assumptions used in the planned agreement analysis.
No statistical analysis plan, sample-size justification, interim analysis information, missing-data method, or analysis-population definition is reported. The registry lists no analyses, confidence intervals, or p-values for the primary outcome. The reason for early termination beyond insufficient sample size is not reported.
These limitations are specific to interpretation of this study record: the endpoint is described, but the data and methodological detail needed to evaluate the intended agreement analysis are absent or incomplete. The safety counts are also limited to the entries reported for the small enrolled group and do not compensate for the missing performance analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Performance of Masimo INVSENSOR00048 (DALI0001) — NCT06922461.
- Registry record last updated 2026-08-25; status last verified 2026-07.
- Results first posted 2026-08-25.
- 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
NCT06922461 is a single-group device study titled “Clinical Performance of Masimo INVSENSOR00048 (DALI0001),” sponsored by Masimo Corporation. It was intended to validate temperature performance of the noninvasive INVSENSOR00048 against a reference thermometer. All participants were assigned to the test group. The registry lists no allocation and no masking.
Enrollment was 4. The study started on 2025-05-02, had a primary completion date of 2025-05-22, and is listed as terminated. The primary outcome was clinical bias and limits of agreement in degrees Celsius over approximately 90 minutes. The registry says early termination and insufficient sample size prevented statistical comparison with reference values, so clinical performance could not be computed. It lists one outcome measure and no analyses.
The recorded safety counts are 0 serious adverse events among 4 at risk, 0 other adverse events among 4 at risk, and 0 deaths. No numerical temperature-performance estimate is reported.