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 Desaturation Validation of INVSENSOR00037 (NCT04002973), a na na study. The primary outcome is Trending Accuracy of the INVSENSOR00037.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04002973 |
| Phase | NA |
| Condition | Healthy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Masimo Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The registry identifies healthy volunteers as the study population and records an enrollment of 11. It does not give further eligibility details or a separate description of the population included in the primary analysis.
Intervention
The investigational device is INVSENSOR00037, a noninvasive sensor placed on a somatic site to measure regional oxygen saturation. The arm description says enrolled participants who took part in data collection received this sensor.
Comparator
The planned reference was a value from an FDA-cleared sensor placed on the contralateral somatic site. This is a within-participant, opposite-site reference described in the study summary, not a separately randomized control arm.
Primary question
The study asks whether measurements from INVSENSOR00037 trend accurately relative to the reference value from the FDA-cleared device. The primary outcome is titled “Trending Accuracy of the INVSENSOR00037,” with a stated unit of percentage of regional oxygen saturation and a timeframe of 1-5 hours.
In practical statistical terms, the question concerns the relationship between measurements from two sensors at different somatic sites, rather than whether participants receiving one treatment have better outcomes than participants receiving another. The registry describes the study as an evaluation of trending accuracy. It does not give a numerical estimate, uncertainty interval, or test result for that accuracy. Accordingly, the clinical question can be described from the stated objective and measurement setup, but the posted record does not establish how closely the investigational readings tracked the reference readings.
3. Trial Design
This is a completed, single-group device study sponsored by Masimo Corporation. The registry lists the phase and allocation as NA and masking as NONE. The study record lists enrollment of 11 and identifies the population as healthy. The recorded start date is 2019-06-21, and the primary completion date is 2019-06-28.
The study description says one investigational INVSENSOR00037 sensor was placed on a volunteer’s somatic site. Its readings were to be compared with a reference value from an FDA-cleared sensor placed on the contralateral somatic site. The arm description states that enrolled participants who participated in data collection received the investigational device. Thus, the design is not a randomized treatment comparison, and the opposite-site reference should not be treated as a separately assigned control arm. The registry itself flags that the arms are not a like-for-like control comparison.
The primary outcome is listed as “Trending Accuracy of the INVSENSOR00037.” Its timeframe is 1-5 hours. The outcome entry identifies the parameter as NUMBER and the unit as percentage of regional oxygen saturation, but does not include a numerical result or a description of a reported estimate. The registry lists one outcome measure and no analyses.
The record does not report the recruitment or measurement protocol in enough detail to determine the exact sequence of sensor readings, the handling of repeated measurements, or the analysis population. It also does not report a trial-specific sample-size justification or a detailed statistical analysis plan. The stated enrollment should therefore be read as a registry design characteristic, not as evidence that the primary outcome was evaluable for every enrolled participant.
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 | INVSENSOR00037 |
|---|---|
| STARTED | 11 |
| COMPLETED | 11 |
| NOT COMPLETED | 0 |
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 | INVSENSOR00037 |
|---|---|---|
| Participants analysed | 11 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 11 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 5 |
| Race/Ethnicity, Customized: African American | Participants | 3 |
| Race/Ethnicity, Customized: Asian or Pacific Islander | Participants | 2 |
| Race/Ethnicity, Customized: Caucasian | Participants | 2 |
| Race/Ethnicity, Customized: Hispanic | Participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Trending Accuracy of the INVSENSOR00037, measured over 1-5 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of regional oxygen saturation |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Trending Accuracy of the INVSENSOR00037.” It is intended to characterize how the investigational sensor’s regional oxygen saturation measurements track relative to a reference value obtained with an FDA-cleared sensor at the contralateral somatic site. The specified timeframe is 1-5 hours, and the unit is percentage of regional oxygen saturation.
Trending accuracy is relevant when the intended measurement use involves following changes over time, rather than relying only on a single reading. In general, an assessment of trending asks whether changes indicated by one measurement method correspond to changes indicated by a reference method. This is distinct from asking whether two devices give identical values at every measurement, and it is also distinct from comparing clinical outcomes between treatment groups.
The registry does not explain the precise definition or calculation of “trending accuracy,” nor does it state what summary statistic, acceptable-performance threshold, or uncertainty measure was used. It lists the parameter as NUMBER but does not report a numerical endpoint result. The outcome’s title and description identify the intended comparison, but they are not enough to infer the magnitude or precision of the observed sensor agreement or tracking.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the purpose and setup of a device-validation study, but it does not report the primary outcome result. Although the primary endpoint is named and its timeframe and unit are stated, there is no posted numerical estimate of trending accuracy, no confidence interval, and no accompanying statistical test result. The central performance question therefore cannot be answered from the posted results record.
The distinction between a stated endpoint and a reported endpoint result matters. An outcome description tells readers what the study was designed to assess; it does not show what measurements were obtained or what the analysis found. Likewise, a completed status indicates that the study is recorded as completed, but does not substitute for reporting the numerical endpoint or the analysis supporting it.
The setup uses an investigational sensor on one somatic site and an FDA-cleared sensor on the contralateral site. This provides a reference comparison described by the registry, but it is not a randomized comparison of treatment groups. The record explicitly notes that the arms are not a like-for-like control comparison. The design should therefore be understood as a device measurement evaluation, not as a trial estimating the effect of assigning participants to alternative treatments.
The registry records enrollment of 11, but does not state how many participants contributed usable data to the primary endpoint or whether all planned measurements were available. It also does not report a participant-level or measurement-level analysis population. Without that information, the enrollment figure alone cannot establish the amount of information contributing to the endpoint.
Precision cannot be assessed because the primary estimate and its uncertainty are not reported. In general, a confidence interval communicates a range of values compatible with the data and analysis, subject to the assumptions of that analysis. No such interval is listed for this endpoint. Readers also cannot determine whether any observed tracking was consistent across participants, whether some measurements were less informative than others, or whether the result depended on particular analytic choices.
The record lists no analyses. It does not report the statistical method used to quantify trending accuracy, the treatment of repeated measurements, or the handling of missing or unusable measurements. It also does not report a prespecified performance criterion. These omissions prevent assessment of how the planned question was translated into an analysis or how the result, if available elsewhere, should be judged against a stated target.
The serious adverse event listing records zero serious events among 11 at risk in the INVSENSOR00037 group. That is a descriptive safety entry for the registered group and should not be read as proof that no events could occur, or as a comparison against another group. The record also lists zero other events among 11 at risk and zero deaths.
Overall, the posted information supports a description of the study’s design, measurement objective, enrollment, and recorded adverse-event counts. It does not support a conclusion about the sensor’s observed trending performance or its precision. That distinction is essential: lack of a numerical result in the registry record is not evidence of either good or poor performance.
9. Statistical Methods Explained
Statistical interpretation of a measurement-validation study begins with the quantity being assessed. Here, the stated aim is trending accuracy: whether measurements from the investigational device track relative to a reference measurement. This is different from a treatment-effect question, where outcomes are compared across groups assigned to different interventions. The registry describes a single-group study and an opposite-site reference measurement, rather than a randomized comparison of treatment groups.
What does a reference comparison represent?
The study description identifies an FDA-cleared sensor on the contralateral somatic site as the source of the reference value. In general, a reference method gives a comparator for interpreting the investigational measurement, but it does not automatically establish that the two measurements are interchangeable. The devices are described as measuring at different somatic sites, so a comparison concerns readings under that setup. The registry does not report further details about how readings were paired, synchronized, or selected for analysis.
For a repeated-measurement question, the unit of analysis can matter. In general, multiple readings from one participant are not necessarily independent observations: readings from the same person may be related to each other. A statistical method that treats correlated readings as independent can misstate uncertainty. The registry record does not say whether repeated readings were analyzed, how any within-participant correlation was handled, or whether the reported endpoint was summarized first at the participant level.
What would an uncertainty interval add?
In general, an uncertainty interval accompanies an estimate to communicate how precisely the quantity has been estimated under the analysis assumptions. A narrow interval indicates more precision than a wide interval, but neither precision nor an interval alone establishes practical importance. Interpretation also depends on what degree of measurement tracking is acceptable for the intended use. The registry does not report an interval, a numerical estimate, or an acceptance threshold for this endpoint.
A statistical test, when used, addresses a particular hypothesis and depends on the chosen model and assumptions. A p-value does not measure the size or practical relevance of an effect. For a device-trending endpoint, a useful interpretation would require knowing the metric, the estimate, its uncertainty, and the criterion against which it is judged. None of these endpoint results is reported in the registry record, and the record lists no analyses. No test result should be inferred from the study’s completed status.
Why can repeated measurements complicate analysis?
In general, repeated observations can reveal how measurements move over time, but they also create dependence within each participant. The way a study handles this dependence affects the estimate and its uncertainty. For example, an analysis may account for clustering or may summarize measurements before analysis; the appropriate choice depends on the design and estimand. The registry does not identify which, if any, approach was used. It also does not provide enough information to determine how measurement timing within the stated 1-5 hours was handled.
Measurement-validation studies can also distinguish association, agreement, and tracking. In general, strong association means readings tend to vary together; agreement concerns how closely values correspond; tracking concerns whether changes align over time. These are related but not interchangeable properties. The registry’s endpoint is described as trending accuracy, but does not define the numerical metric. It is therefore not possible to translate the endpoint label into a particular statistical quantity or to say what its value would mean.
What can enrollment and planning assumptions tell us?
The registry records enrollment of 11. Enrollment is a design and recruitment quantity; it does not by itself state how many participants had usable primary-outcome data or how many measurement pairs entered an analysis. The registry does not report a trial-specific sample-size justification. Any sample-size illustration based on an observed effect would be a planning exercise rather than observed evidence about the study’s power or performance. No sample-size calculation or target is reported as part of the trial’s own statistical plan.
In general, power is a design property tied to assumptions about the effect to be detected, variability, analysis, and significance level. It is not a measure of whether a completed study has demonstrated that a result is true. A calculation based on an observed estimate can be especially difficult to interpret as retrospective power; the estimate itself is uncertain. For this record, the missing endpoint estimate and variability also mean that readers cannot assess precision from the enrollment figure alone.
The posted record supplies no numerical primary outcome result, uncertainty measure, analysis description, or threshold. Statistical methods can explain what kinds of information are needed to interpret a device-validation endpoint, but they cannot recover those missing study-specific results. The correct reading is that the registry states a measurement objective and design while leaving the primary statistical finding unreported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no analyses. It does not report whether the investigators assessed additional outcomes outside the registry listing, conducted multiple versions of the primary analysis, or adjusted for multiple statistical tests. Without such information, the extent of any multiplicity and its handling are not reported in the registry record.
In general, multiplicity arises when several hypotheses or analysis choices are considered. Repeated testing can increase the chance of a nominally unusual finding, while adjustment methods aim to account for that when appropriate. The relevance of multiplicity depends on what was planned and what was analyzed. The registry entry does not provide a statistical analysis plan, so it is not possible to determine whether a multiplicity procedure was needed or used.
The record does not describe missing-data methods, exclusions, or the number of participants with evaluable primary measurements. It gives enrollment of 11, but does not state whether the primary analysis included all enrolled participants. In general, missing measurement data can affect both the precision and representativeness of an estimate, particularly if availability is related to the measurements or study conditions. No assumptions or sensitivity analyses addressing missingness are reported.
Analysis populations are also not specified. The registry does not identify a population for the primary endpoint, nor explain how participants with incomplete measurements would be treated. These details are important for understanding which observations support an estimate and whether the analysis follows a prespecified rule. Because neither the analysis population nor a numerical endpoint result is reported, the primary finding cannot be reconstructed from the registry record.
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 |
|---|---|---|---|
| INVSENSOR00037 | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| INVSENSOR00037 | 0 of 11 |
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 |
|---|---|
| INVSENSOR00037 | 0 of 11 |
The adverse-event entry for the INVSENSOR00037 group lists 11 participants at risk for serious adverse events and zero affected. It also lists 11 at risk for other events and zero affected, with zero deaths. These are the counts recorded in the registry for the listed group.
These figures are descriptive counts, not estimates from a comparison between randomized groups. The study is listed as single-group, and the registry notes that its arms are not a like-for-like control comparison. The counts therefore do not provide a comparative safety effect.
In general, observing zero events in a study does not establish that the underlying event risk is zero. The interpretation depends on the number of people observed, the length and completeness of safety follow-up, and how events were defined and collected. The registry record does not provide further detail about safety surveillance duration or event ascertainment. The listed timeframe of 1-5 hours is the primary outcome timeframe, not a separately stated safety follow-up period. The adverse-event entries should be read as the reported counts for this record, not as a guarantee that no event occurred outside the recorded definitions or observation process.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed study was designed to evaluate the trending accuracy of the INVSENSOR00037 against a reference value from an FDA-cleared sensor placed at the contralateral somatic site. It identifies healthy volunteers, enrollment of 11, a primary outcome timeframe of 1-5 hours, and the intended measurement domain of regional oxygen saturation. These details describe the research question and its setting.
The record does not report the numerical primary outcome result. It therefore does not show how accurately the investigational sensor tracked the reference, how much variability there was, or how precisely performance was estimated. It also does not report an acceptance criterion by which a result could be judged. No conclusion about observed performance can be drawn from the endpoint title or the completed study status alone.
The design does not compare treatment groups. An FDA-cleared sensor serves as a reference at the opposite somatic site, according to the study description. That reference is not a randomized control group, and the record specifically indicates that the arms are not a like-for-like comparison. The findings, if reported elsewhere, would need to be interpreted in light of this measurement setup rather than as evidence of a treatment effect.
The record also does not explain the statistical method, analysis population, handling of repeated observations, or missing-data approach. Those omissions limit the ability to evaluate bias and precision. The listed zero serious events and zero other events are descriptive entries for the registered group and do not establish comparative safety or absence of risk.
In general, a validation result is most informative when the metric, numerical estimate, uncertainty, measurement conditions, and performance criterion are all clear. The registry provides the objective and some design characteristics, but not these key result details. The appropriate conclusion is limited: the study was registered as a completed evaluation, while its primary statistical finding is not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically important because device validation asks a different question from the more familiar comparison of clinical outcomes across randomized treatment groups. The target is the behavior of measurements: whether an investigational sensor’s readings track a reference measurement under the described conditions. That requires clear definition of the measurement metric and careful attention to how observations from the same participant relate to one another.
The registry describes an investigational sensor at one somatic site and an FDA-cleared reference sensor at the contralateral site. This setup makes the reference measurement central to interpretation, while also making clear why it should not be mistaken for a conventional control arm. Results from such a design need to be understood as a device-measurement comparison, with the stated site arrangement and measurement period in view.
Statistical reporting matters because a claim of “trending accuracy” is not itself a numerical result. Readers need the chosen metric, its estimate, an indication of precision, and a clear criterion for judging performance. When repeated readings are involved, the analysis must also explain how their dependence is handled. The registry record does not report these details or a primary numerical result, so the study’s statistical contribution cannot be evaluated from this entry alone.
The record illustrates another general point: enrollment does not equal an endpoint result. Enrollment of 11 indicates the recorded study size, but does not show how many participants contributed usable data or how informative those measurements were. Transparent reporting of analysis populations, missingness, and uncertainty would help readers judge the strength and limits of a validation finding.
Finally, separating design information from results prevents overinterpretation. A completed study status and an endpoint description show what was registered and that the study is recorded as complete. They do not establish what the analysis found. Clear registry reporting is essential for determining whether a device-validation question was answered and how much confidence the evidence warrants.
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 of the registry record is that it does not report a numerical result for the primary endpoint. The endpoint title, unit, and timeframe are listed, but there is no estimate of trending accuracy or measure of its precision. This prevents assessment of the study’s central performance question.
The endpoint is not defined in enough statistical detail to identify the precise metric. The record does not state how trending accuracy was calculated, what data contributed to the calculation, or whether a prespecified performance threshold was used. Consequently, even a hypothetical value could not be interpreted against a stated criterion from this record alone.
The study enrolled 11 participants, but the number contributing usable primary-outcome data is not reported. The record also does not describe missing measurements, exclusions, participant-level analysis, or the treatment of repeated readings. These omissions make it difficult to judge how representative the analyzed data were or how precisely the endpoint could have been estimated.
The measurement arrangement involves the investigational sensor and an FDA-cleared sensor at contralateral somatic sites. The registry does not provide further details about measurement timing, pairing, or other conditions needed to understand the comparison. It also does not report masking beyond listing masking as NONE.
Finally, the record lists no analyses and does not report a statistical analysis plan, sample-size justification, or details of multiplicity handling. These are reporting limitations of the registry entry; they do not establish that the study did or did not use particular procedures. The adverse-event listing is also limited to recorded counts, without further information about ascertainment or a separately stated safety follow-up period.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Desaturation Validation of INVSENSOR00037 — NCT04002973.
- Registry record last updated 2020-10-20; status last verified 2020-09.
- Results first posted 2020-10-20.
- 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
The registry describes a completed, single-group study of INVSENSOR00037 in healthy volunteers, sponsored by Masimo Corporation. Enrollment is recorded as 11. The investigational sensor was to be placed on a somatic site, with readings compared against an FDA-cleared sensor at the contralateral site. The primary outcome is titled “Trending Accuracy of the INVSENSOR00037,” with a timeframe of 1-5 hours and a unit of percentage of regional oxygen saturation.
The record lists phase and allocation as NA, masking as NONE, one outcome measure, and no analyses. It does not report a numerical primary endpoint result, an uncertainty estimate, or a detailed statistical method. The adverse-event entry lists zero serious events, zero other events, and zero deaths among the recorded group. These entries are descriptive and do not establish comparative safety. The registry supplies design and outcome-intent information, but not the primary statistical finding needed to evaluate the sensor’s reported performance.