A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters (NCT01196533), a na na study. The primary outcome is Comparison of the TensorTip Accuracy Against Hospital Periodical Readings..

2. Clinical Question

The clinical question is therefore a measurement-comparison question, not a question about the effect of a treatment on a health outcome. It concerns whether device readings correspond to readings obtained using reference methods in hospitalized patients. The stated approach was to record eligible TensorTip signals simultaneously with monitoring, then compare device readings with the reference results.

The record describes the calculation at the level of each parameter, but does not enumerate the parameters in the primary outcome description. It also does not report participant characteristics, the number of usable signals, or the number of paired measurements. The listed conditions should not be treated as proof that every enrolled participant had one of those conditions. The record does not provide enough detail to determine which patient groups or measurement settings contributed to the accuracy assessment.

3. Trial Design

This was a completed, single-group device study of non-invasive peripheral blood monitoring. The registry reports an enrollment of 94. The listed intervention was a device, described as non-invasive peripheral blood monitoring; the arm description names Non Invasive Monitoring. The trial status is completed. Its recorded start was 2010-08, and its primary completion was 2013-07.

The design is not described as a randomized comparison. Allocation is listed as NA, and masking is listed as none. The trial model is single group. These details mean the record does not describe random assignment to separate TensorTip and control arms or masking of the measurement process. The intended comparison instead appears in the outcome description: eligible device signals were to be recorded simultaneously with monitoring, and device readings were to be compared with reference results.

The study title and aim describe comparisons with other devices, but the design fields do not identify a separate comparator arm. The record refers to registered FDA-approved invasive and non-invasive devices in its summary and to standard invasive techniques in the primary outcome description. The names of the reference devices, the procedures used to obtain reference readings, and any device-specific comparison results are not reported in the registry record.

The trial phase is listed as NA. The registry record does not report a sample-size justification, a detailed statistical analysis plan, or a planned interim analysis. Those details should not be inferred from the enrollment or from sample-size planning illustrations associated with the results. The illustrations are not the trial’s original design description and do not constitute observed power.

The record describes an accuracy assessment in hospitalized patients over a timeframe of one year. It does not explain how that timeframe relates to the overall recorded study dates, nor does it specify the timing or frequency of measurements for individual participants. Participant flow, eligibility criteria, and the number of participants contributing analyzable measurements are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

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 Comparison of the TensorTip Accuracy Against Hospital Periodical Readings., measured over one year.

The primary outcome is titled Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. Its unit is percentage of error, and the measure is specified as a number. The timeframe is one year. The stated purpose is to validate parameters against similar measures obtained with standard invasive techniques in hospitalized patients.

The registry describes an error statistic based on the square root of the average squared differences between reference readings and device readings. In general, this type of root mean square error summarizes the size of discrepancies while giving larger discrepancies more influence because the differences are squared before averaging. The result is expressed in the outcome’s stated percentage-of-error unit. The record does not explain how any underlying readings were converted to that percentage scale.

In general, an accuracy measure is useful when the study question concerns agreement between a new measurement method and a reference method. It provides information about the size of measurement differences rather than simply whether two measurements move together. The record says that results for each parameter would be displayed against a regression line, but it does not report those results or identify the parameters evaluated.

The description says a result would be considered satisfactory when the error met an industry requirement. The requirement itself is not reported in the registry record. Nor are numerical endpoint estimates, uncertainty intervals, or parameter-level findings reported. Consequently, the stated endpoint and calculation can be described, but the accuracy achieved cannot be assessed from the registered outcome information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

In general, a measurement-validation study compares readings from a new method with readings from a reference method. The goal is to characterize how closely paired measurements agree, not merely whether they are associated. The registry describes this type of comparison: eligible TensorTip color signals were to be recorded simultaneously with monitoring, with reference results obtained using standard invasive techniques. The specific reference instruments and the pairing rules are not reported in the registry record.

What does the error formula summarize?

The primary outcome description gives a root mean square error calculation. In general, this statistic takes the difference between each reference value and corresponding device value, squares the differences, averages them, and takes the square root. Squaring makes larger discrepancies contribute more heavily than smaller ones. The resulting summary expresses the typical scale of discrepancies in a way that retains the unit of the underlying difference, subject to the record’s stated percentage-of-error presentation.

Such a summary can be useful for an overall accuracy assessment, but it does not describe every feature of agreement. In general, two methods can have a small average error while still differing systematically in some ranges or subgroups. A single error value also does not show whether the device tends to over-read or under-read, because the direction of individual differences is not retained in the squared terms. The registry record does not report complementary measures of directional bias or the distribution of individual differences.

Why does the reference method matter?

In general, an accuracy estimate depends on the quality and consistency of the reference readings. If the reference method has measurement error, differences between the new device and reference may reflect error in either method. The record describes the intended references as registered FDA-approved invasive and non-invasive devices in its summary and as standard invasive techniques in the primary outcome description. It does not identify the devices, their procedures, or how disagreements between multiple reference readings would be handled. This limits interpretation of the intended comparison.

What does simultaneous recording contribute?

In general, collecting paired measurements at the same time can reduce the chance that differences arise only because the underlying physiological state changed between measurements. The registry says eligible real-time color signals would be recorded simultaneously during monitoring. It does not report whether simultaneous recording was achieved for all measurements, how timing was defined, or how records were matched. Those operational details matter when interpreting paired measurement differences.

Why can repeated readings require special analysis?

In general, a study may collect multiple measurements from each participant. Readings from the same person are often more alike than readings from different people, so treating every reading as independent can make uncertainty appear smaller than it is. The registry says the analysis would use the entire set of eligible recorded signals, but does not report the number of signals, the number per participant, or whether the analysis accounted for clustering or repeated measures. The appropriate interpretation therefore cannot be checked from the registry description alone.

What is the role of a threshold?

The registry states that a satisfactory result would be one in which the error met an industry requirement. In general, a prespecified acceptance threshold gives context to an accuracy estimate by defining what level of discrepancy is considered acceptable for the intended use. The threshold and its source are not reported in the registry record. Without that information, even a numerical error estimate would be difficult to interpret against the stated decision criterion. The record also does not report whether the criterion applied separately to each parameter or to an overall summary.

How should uncertainty be understood?

In general, a point estimate is an estimate from the observed data, while a confidence interval communicates uncertainty around that estimate under a specified statistical method. Precision can depend on the number and distribution of usable paired readings, as well as on within-participant correlation and measurement variability. No primary estimate, confidence interval, or other uncertainty measure is reported in the registry record. The enrollment count alone cannot establish the precision of the accuracy assessment.

The registry describes plotting each parameter against a regression line. In general, regression can help show how measurements relate across their range, but correlation or a fitted line alone does not establish agreement. A device could track changes in the reference while retaining a systematic offset. The record does not report the fitted results, residual patterns, or other plots or summaries needed to assess that possibility.

The sample-size material associated with the posted results is described as a planning illustration based on an observed effect, with assumptions for a two-arm calculation. It is not a report of the trial’s design rationale, and it should not be read as observed power or as evidence that the trial had a particular level of power. The registry record does not report the original sample-size justification. These planning assumptions also do not change the registered single-group design.

More broadly, the statistical plan for the trial is not reported in the registry record. The recorded outcome description provides a formula and an intended signal-analysis approach, but does not specify the full set of model choices, uncertainty calculations, or decision rules. General statistical principles can explain why those details matter, but they cannot establish which analyses were actually conducted.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure and one analysis. At the same time, the outcome description refers to evaluating each parameter, and the summary refers to measurement of certain biomarkers and vital signs. The parameters included in the analysis are not enumerated in the registry record. It is therefore unclear how many distinct measurement comparisons were planned or reported.

In general, evaluating many parameters creates a multiplicity issue: the more comparisons made, the greater the opportunity for some results to appear favorable by chance. Strategies for addressing this can include prespecifying a limited set of primary comparisons or adjusting interpretation for multiple testing. The registry record does not report a multiplicity plan, a hierarchy of parameters, or whether any adjustment was used. Because numerical parameter-level results are also not reported, the extent of any multiplicity concern cannot be assessed.

The outcome description refers to all eligible recorded signals, but the registry record does not define eligibility at the signal level or report how many signals were omitted. It does not describe how missing or unusable measurements were handled, whether exclusions were made before or after examining results, or whether sensitivity analyses were performed. Missing-data methods are not reported in the registry record.

The analysis population is also not defined. The enrollment count does not show how many participants contributed measurements to the primary analysis, and there is no reported accounting of participants or signals excluded from analysis. The registry record does not report whether analyses used all enrolled participants, only participants with paired readings, or another population. These omissions limit assessment of the completeness of the outcome analysis and the possibility of selection effects.

11. Safety Results

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

Other (non-serious) adverse events

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

The adverse-event record lists the Non Invasive Monitoring group with 94 participants at risk for serious adverse events and 0 affected. It also lists 94 participants at risk for other adverse events and 0 affected. These are the posted counts for the group; they are not a comparison between independently assigned treatment arms, because the trial is described as single group.

The deaths field is null. Death information is therefore not reported in the registry record; a null entry should not be interpreted as a reported count of zero deaths. The record does not list serious adverse-event terms, and no event terms are included among the top serious terms.

In general, a zero count in a registry safety field means no affected participants were entered for that category in the posted record. It does not by itself establish that no events occurred under every possible definition or that all events were captured. Interpretation also depends on the observation period, event definitions, reporting completeness, and follow-up procedures. Those details are not reported in the registry record.

The timeframe for the primary accuracy outcome is one year, but the safety record does not specify the adverse-event observation period. The available counts should therefore be read narrowly as registry-reported counts, not as a complete assessment of safety or as evidence about comparative risk.

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

The registry record establishes that this completed study was intended to assess TensorTip measurement accuracy by comparing device readings with hospital or standard-method readings. It identifies a root mean square error approach and describes simultaneous recording of eligible signals. Those details make the central statistical question understandable: how large were the discrepancies between paired device and reference readings?

The record does not report the numerical primary outcome, parameter-specific estimates, confidence intervals, or the industry requirement used to define satisfactory accuracy. As a result, the posted information does not establish the observed degree of agreement or its precision. It also does not permit an assessment of whether the planned criterion was achieved. The absence of these numerical findings in the registry record should not be mistaken for evidence either of good or poor accuracy.

The single-group design is compatible with a comparison of a new device against reference readings collected in the same setting; it is not a randomized, like-for-like comparison of separate groups. The record does not describe a control arm or randomized allocation. Accordingly, the trial description is best understood as a measurement comparison, not as a trial estimating the effect of a treatment.

In general, measurement accuracy is only one component of evaluating a device. Interpretation can also depend on which parameters were assessed, the patient and measurement settings represented, the quality of the reference method, and how repeated signals and missing readings were handled. The registry record does not report enough detail to assess these aspects fully. The listed conditions likewise do not establish which diagnoses were represented in the analyzed sample.

The enrollment of 94 describes the recorded number enrolled, but does not indicate the number of paired readings or the precision of any accuracy estimate. Similarly, the completed status indicates trial status, not that all planned measurements or analyses are available in the registry. The responsible interpretation is limited: the record documents an accuracy-assessment plan and some design features, while the primary numerical result and key analysis details are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial raises a central statistical issue in device evaluation: a new method needs to be compared with a reference in a way that measures agreement, not merely association. A device may produce readings that track a reference without matching its values closely. The registry’s use of a root mean square error is directed at the size of discrepancies, making the choice of accuracy summary important to the scientific question.

It also highlights the importance of reporting results at the level of the measurements being evaluated. The outcome description refers to each parameter and to all eligible recorded signals. In general, readers need to know how many parameters and paired readings contributed, how repeated signals were handled, and what uncertainty surrounds each estimate. Without those details, a summary measure can be hard to evaluate or reproduce.

The described industry requirement is another statistically important element. In general, a criterion can connect an error estimate to a decision about whether a measurement method meets a stated standard. A result cannot be judged against that standard unless the threshold and the relevant results are reported. Here, the registry record describes the criterion concept but does not report its value or the outcome estimates.

The record also illustrates why enrollment and analyzed data are different quantities. Enrollment is reported as 94, while the number of eligible paired signals and the number of participants contributing to the primary analysis are not reported. For measurement studies, the structure and completeness of readings can matter as much as participant count when interpreting precision.

Finally, statistical transparency is essential to interpreting a completed accuracy study. The registry gives a broad endpoint description, but does not report the numerical primary findings, uncertainty, analysis population, or handling of missing signals. Those gaps prevent readers from evaluating the strength and precision of the evidence from the registry record alone.

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.

Several limitations specific to this trial’s registry description constrain interpretation. The principal limitation is that the numerical primary outcome is not reported in the registry record. The error estimate, its uncertainty, and any parameter-level results are unavailable, so the magnitude and precision of the device-reference discrepancies cannot be assessed.

The stated industry requirement for a satisfactory result is not reported. The specific physiological or blood chemistry parameters assessed are also not enumerated, despite the outcome description referring to each parameter. The registry record does not explain how percentage error was derived from the underlying readings or whether the acceptance criterion applied separately to each measurement.

The reference devices and measurement procedures are not identified. The summary refers to FDA-approved invasive and non-invasive devices, while the outcome description refers to standard invasive techniques. The record does not resolve which methods formed the actual reference comparisons or describe their calibration, timing, or repeatability.

The design information is limited to a single group, no masking, and allocation listed as NA. The record does not provide detailed eligibility criteria, participant characteristics, signal counts, participant flow, or the number of participants with analyzable paired readings. It is therefore not possible to evaluate how representative the analyzed measurements were or how broadly the intended accuracy findings might apply.

Important analytic details are also not reported: the complete statistical plan, handling of repeated measurements, missing-data methods, analysis population, multiplicity approach, and uncertainty calculations. The safety record reports zero affected participants in the listed serious and other adverse-event categories, but does not specify the observation period or event ascertainment procedures; deaths are not reported in the registry record. These limitations reflect what the registry record documents and do not establish what may have been reported elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters — NCT01196533.
• Registry record last updated 2019-01-31; status last verified 2018-07.
• Results first posted 2019-01-31.
• 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

NCT01196533 is a completed, single-group device trial sponsored by Cnoga Medical Ltd. It enrolled 94 participants and evaluated non-invasive peripheral blood monitoring with the TensorTip. The record lists no masking, allocation as NA, and trial phase as NA. The recorded start was 2010-08, with primary completion in 2013-07.

The primary outcome concerns TensorTip accuracy compared with hospital periodical readings. The description specifies a root mean square error calculation and a one-year timeframe, with comparison against similar measures obtained using standard invasive techniques. The registry record does not report numerical primary results, uncertainty estimates, the parameters assessed, or the industry requirement for satisfactory accuracy.

The adverse-event record lists 0 serious and 0 other affected participants among 94 at risk in the Non Invasive Monitoring group. Deaths are not reported in the registry record. The analysis population, missing-data approach, multiplicity plan, and full statistical analysis plan are also not reported in the registry record.