mobiCARE™ ECG Monitoring System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for mobiCARE™ ECG Monitoring System (NCT06896734), a registered phase not stated study. The primary outcome is Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions.

2. Clinical Question

The central statistical question is about measurement interpretability across electrode positions, not a clinical treatment effect. A change in electrode position could affect the recorded signal’s appearance, so the study evaluates whether a reader can still identify the rhythm relative to the nominal-position recording. The registry describes the primary effectiveness evaluation as a difference in interpretability between the nominal and three alternative electrode placement locations. However, the record does not report a numerical difference, uncertainty interval, or statistical test for that evaluation.

Because the positions are evaluated within a study of the same system and participants, the nominal location is a reference rather than a separate randomized control group. The Holter monitor is described as a contemporaneous point of reference for noting rhythm changes; the record does not specify a formal statistical comparison with Holter readings. Therefore, the registry supports describing the question and measurement approach, but not a conclusion about how often alternate positions produced interpretable signals.

3. Trial Design

This is a prospective, non-randomized, single-center U.S. study of the mobiCARE™ ECG Monitoring System. The registry lists the study as completed and reports enrollment of 49. The study start date is 2025-01-01 and primary completion is listed as 2025-02-05. These registry entries describe the study’s administrative status and timing; they do not supply results for the primary endpoint.

The intervention is described as evaluation of the ECG signal in the nominal location and in three alternate positions. The primary outcome description refers to the nominal position and up to three additional alternate positions for each subject. ECG rhythm data were collected at each location during normal use while the subject was sitting, standing and ambulating. The primary endpoint timeframe is described as 2 minutes while the patient ambulates; the outcome description also says data were collected for at least 2 minutes during normal use. A simultaneous Holter monitor was to be measured at the same time points as a reference if rhythm changes were noted on the mobiCARE™ system.

The study is not described as a randomized allocation to competing treatment groups. The location comparisons are therefore not equivalent to a randomized, parallel-group trial. The registry does not report the allocation process, a control arm, or a detailed protocol for order of electrode placements. It also does not report whether all participants contributed evaluable recordings at every position or activity condition.

The record lists five outcome measures, including the primary interpretability outcome and secondary measures concerning artifact, ECG morphology, human factors, and measurable P-waves. The record does not provide results for those measures. Details of the statistical analysis plan, including the planned tests and handling of repeated 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

Analysis population for the primary outcome, as defined in the registry: Primary Effectiveness Evaluation: Difference in Interpretability of ECG Signal for MobiCARE™ Nominal and Three Alternative Electrode Placement Locations

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 Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions, measured over 2 minutes while the patient ambulates.

The primary endpoint is the number of participants in whom the ECG signal is interpretable at the nominal location and up to three alternate positions. The registry defines “interpretable” as a situation in which an independent cardiologist reader can identify the ECG rhythm at each location when compared with the rhythm measured at the nominal position. This makes the endpoint a count of participants meeting a stated reading criterion, rather than a continuous measurement of signal quality.

The endpoint is used to assess whether electrode placement away from the nominal location still yields a rhythm that can be identified in relation to the nominal-position signal. The registry frames the primary effectiveness evaluation as a difference in interpretability between the nominal location and three alternative electrode placement locations. It describes recordings during sitting, standing and ambulating, with the primary timeframe specified as 2 minutes while ambulating. The Holter monitor was intended to offer a simultaneous reference if rhythm changes were observed, but the registry does not describe it as the formal primary endpoint comparator.

The record does not state the number of participants meeting the interpretability criterion, the denominator of evaluable recordings, or an effect estimate comparing locations. It also does not report a confidence interval or statistical test. Consequently, the endpoint’s definition and intended role can be explained, but its observed performance cannot be inferred from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome is a participant count based on a binary criterion: a reader either can or cannot identify the ECG rhythm at a location under the registry definition. That definition is tied to comparison with the rhythm at the nominal position. Although the endpoint is recorded as a count, a count is most interpretable alongside its denominator, because the same count can have different meanings in populations of different sizes. The registry reports enrollment of 49 but does not report the primary outcome count or the number of evaluable participants for each placement.

What does interpretability mean statistically?

The endpoint operationalizes a judgment about the recorded signal. The independent cardiologist reader is asked to identify rhythm at the nominal and alternate locations, using the nominal-position rhythm as the reference. This turns a qualitative reading task into a criterion that can be counted across participants. General statistical explanation: converting a reading judgment into a defined outcome can improve consistency, but interpretation still depends on how the criterion is applied and how reader disagreements or indeterminate readings are handled. Those procedures are not reported in the registry record.

The outcome description refers to evaluations at multiple locations for each participant. Such observations are related because they come from recordings within the same participant. General statistical explanation: analyses of repeated or paired observations should account for that dependence; treating related readings as if they came from unrelated participants can give misleading estimates of uncertainty. The registry record does not report which statistical method, if any, was planned or used to compare locations.

How should the nominal position be understood?

The nominal position is the reference for judging the alternate-position rhythm readings, rather than a separately randomized control group. This helps define the comparison of interest, but the design does not by itself isolate every possible reason for differences between recordings. The order of positions, reading procedures and handling of recordings that cannot be interpreted are not reported in the registry record. The simultaneous Holter monitor is described as a point of reference if rhythm changes are noted, but the registry does not give a formal agreement method or a statistical result for comparison with Holter data.

The study is prospective and non-randomized, with one center. Prospective collection means the study description concerns measurements gathered according to a study process rather than only a retrospective review; the registry does not give enough detail to characterize all collection procedures. General statistical explanation: random allocation is often used to balance known and unknown factors between comparison groups, while a non-randomized design does not offer that same protection. Here the central comparison concerns electrode positions within the system, and the registry does not describe randomized assignment to position order.

What would an uncertainty interval contribute?

For a binary participant-level outcome, a statistical summary could include a count, denominator and an interval around an estimated proportion or difference. General statistical explanation: a confidence interval communicates how precisely a quantity is estimated under the chosen statistical method and its assumptions. It is not a guarantee that the true value lies within the interval. No primary endpoint estimate or confidence interval is reported in the registry record, and no method for calculating one is specified.

A test of a difference would address a different question from describing the observed data. General statistical explanation: a p-value, when used, summarizes how unusual data at least as inconsistent with a specified null model would be under that model and its assumptions; it does not measure clinical importance or the probability that the null hypothesis is true. No p-value, hypothesis test, or null hypothesis for the primary endpoint is reported in the registry record.

What do the planning illustrations represent?

The record’s sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also specify that the effect to detect is a stated fraction of the observed effect. These are assumptions for sample-size illustrations, not a description of the trial’s own design or evidence of an analysis performed in this study. The record does not report numerical sample-size illustration results in the study details, and such planning values should not be interpreted as observed power. The assumptions refer to two arms, but the trial itself is described as non-randomized and does not report a like-for-like control comparison.

General statistical explanation: power is a design-stage probability of detecting a specified effect under stated assumptions. It is not a measure of whether a completed study’s result is reliable, and calculating power from the observed effect after a study does not add independent evidence about that effect. The primary endpoint result is not reported, so no observed-effect calculation can be interpreted from this registry entry.

The record lists no analyses. As a result, statistical methods used for the primary endpoint, secondary endpoints, reader assessments and any repeated-measures comparison are not reported in the registry record. A reader should distinguish these absent analysis details from the endpoint definition and study design that are documented.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Nominal Location", "Alternate Position 1", "Alternate Position 2", "Alternate Position 3")
n      <- c(49, 49, 49, 49)
events <- c(49, 49, 49, 49)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Nominal Location  49  49  100.0  92.7  100.0  92.7  100.0  92.9  99.9
ARM  Alternate Position 1  49  49  100.0  92.7  100.0  92.7  100.0  92.9  99.9
ARM  Alternate Position 2  49  49  100.0  92.7  100.0  92.7  100.0  92.9  99.9
ARM  Alternate Position 3  49  49  100.0  92.7  100.0  92.7  100.0  92.9  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures: the primary ECG interpretability measure and secondary measures concerning artifact, morphology, human factors and measurable P-waves. It does not report results for these outcomes or analyses. The record also does not state whether the outcomes were assigned a hierarchy, whether any were exploratory, or whether adjustments for multiple testing were planned. These matters are not reported in the registry record.

General statistical explanation: when several outcomes or comparisons are tested, the chance of at least one apparently notable result can increase if each is assessed separately without a multiplicity strategy. A prespecified hierarchy, adjustment, or clearly exploratory interpretation can help readers understand the role of multiple tests. The registry information does not indicate which approach, if any, was used, so no conclusion about multiplicity control is possible.

Missing-data handling is also not reported. The endpoint involves readings at multiple positions, but the record does not say how unavailable, incomplete, poor-quality or uninterpretable recordings were treated in the analysis. It does not give the number of participants with evaluable data at each position, or whether every enrolled participant was included in each endpoint analysis. Enrollment should therefore not be treated as the denominator for an outcome unless the registry reports that explicitly.

The analysis populations are not described. The record does not specify whether analyses used all enrolled participants, only participants with usable recordings, or another defined set. It also does not report a statistical analysis plan, interim analyses, or a method for addressing missing observations. Each of these items is not reported in the registry record; their absence does not establish which approach was used.

12. 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 adverse-event entry lists 49 participants at risk for serious adverse events and 49 at risk for other adverse events. It records zero serious adverse events, zero other adverse events and zero deaths. These are the event counts recorded in the registry.

Zero recorded events should be read as a statement about the counts in this record, not as proof that risk is absent. The registry information does not specify the safety observation period, event-collection procedures, event definitions, or whether all events were actively solicited. The record does not list serious adverse event terms. It also does not provide a separate explanation of how the at-risk counts were determined.

General statistical explanation: when no events are observed, the underlying event rate is not thereby known to be zero; uncertainty depends on the amount and quality of follow-up and on the statistical method used. No interval estimate for safety events is reported in the registry record. The safety counts should be interpreted separately from the primary endpoint, for which the interpretability result is not reported.

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

The registry record supports a description of a completed, prospective, non-randomized, single-center study evaluating ECG signal interpretability at the mobiCARE™ system’s nominal electrode location and alternate locations. It identifies the primary outcome definition, the intended comparison with the nominal-position rhythm, the activity conditions described for recording, and the use of a simultaneous Holter monitor as a reference if rhythm changes were noted. It also reports enrollment of 49 and the recorded adverse-event counts.

The record does not report the primary outcome count, denominator, difference between positions, confidence interval or p-value. It therefore does not show how often the ECG rhythm was interpretable at any location or how precisely a comparison was estimated. Nor does it report findings for the secondary outcome measures. No conclusion about the magnitude, direction or statistical uncertainty of the interpretability findings can be drawn from the registry record.

The study is not described as randomized, and the nominal position is the reference for alternate-position readings rather than a separate randomized control group. The Holter monitor is described as a reference for noting rhythm changes; no agreement or comparative result is reported. The record therefore cannot establish a statistical relationship between mobiCARE™ readings and Holter readings.

The zero adverse-event counts are registry entries and should not be interpreted as proof of zero risk. The safety observation period and event-collection details are not reported. Similarly, completion status and enrollment describe the study record, not the strength of evidence for the primary endpoint.

In general, a result is more informative when the outcome definition, numerator, denominator, analysis method and uncertainty are all available. Here, the endpoint definition is documented, but the results and analysis details are not. The appropriate reading is that the registry describes what the study set out to evaluate, while leaving the observed interpretability findings unreported.

14. Why This Trial Matters Statistically

This study raises a measurement question with direct statistical implications: whether ECG rhythm can be identified when electrodes are placed at the nominal location or at alternate locations. The endpoint depends on a defined reading criterion, and the registry identifies the nominal-position rhythm as the reference. That makes clarity about reader procedures, repeated measurements and the treatment of indeterminate recordings important to interpretation.

The within-participant structure matters. Readings at different positions from the same participant are related, so a statistical comparison should reflect that dependence. General statistical explanation: accounting for pairing can improve the relevance and precision of a comparison when the data structure supports it; ignoring the pairing can misrepresent uncertainty. The registry record does not report the analysis method used for the location comparisons.

Another important issue is the distinction between an endpoint definition and an endpoint result. The registry provides a detailed description of what counts as interpretable, but it does not provide the observed count, denominator, effect estimate or confidence interval. Without those elements, readers cannot assess the frequency of interpretable signals or the precision of any difference across locations.

The record also names secondary measures that could describe signal artifact, morphology, human factors and measurable P-waves. Their results and relationship to the primary outcome are not reported. Multiplicity handling is not reported either, so the interpretive role of multiple outcomes cannot be assessed.

These design and reporting features matter because the study question is about measurement performance under different electrode placements, not a treatment comparison. The registry makes the evaluation framework visible but leaves the statistical findings unavailable. Separating documented design details from unreported results is essential to a calibrated reading of the evidence.

15. 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 interpretation is that the registry record does not report the primary endpoint result. There is no participant count meeting the interpretability criterion, no outcome denominator, and no estimate comparing the nominal and alternate locations. Precision cannot be assessed because no confidence interval is reported, and statistical evidence cannot be assessed because no test result is reported.

The record does not describe how many participants had usable ECG recordings at each position or activity condition. It does not report how missing, incomplete, artifact-affected or indeterminate recordings were handled. The endpoint involves readings across locations, but the statistical method for accounting for within-participant measurements is not reported.

The study is described as non-randomized and single-center. The registry does not report the order in which positions were tested, whether position order was controlled, or how readers were trained or whether their assessments were blinded. These details are not reported in the registry record and should not be assumed. The Holter monitor’s role is described as a reference if rhythm changes occur, but no agreement analysis or result is given.

The registry lists secondary outcome topics but no corresponding findings. It does not report a multiplicity strategy, a statistical analysis plan, analysis populations, interim analyses, or sample-size justification for the study’s own design. The sample-size assumptions describe planning illustrations and do not supply evidence about the primary result.

The adverse-event entry reports zero serious events, zero other events and zero deaths among 49 at risk, but the safety observation period and collection procedures are not reported. Accordingly, neither the missing interpretability findings nor the scope of safety ascertainment can be resolved from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: mobiCARE™ ECG Monitoring System — NCT06896734.
• Registry record last updated 2025-05-09; status last verified 2025-04.
• Results first posted 2025-05-09.
• 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.

19. Record Summary

NCT06896734 is a completed, prospective, non-randomized, single-center U.S. study sponsored by Seers Technology Co., Ltd. It evaluates the mobiCARE™ ECG Monitoring System at the nominal electrode position and up to three alternate positions. Enrollment is listed as 49. The study start date is 2025-01-01, and primary completion is listed as 2025-02-05.

The primary endpoint counts participants whose ECG signal is interpretable at the nominal location and alternate locations, using an independent cardiologist’s ability to identify rhythm relative to the nominal-position rhythm. Recordings are described during sitting, standing and ambulating, with a simultaneous Holter monitor as a reference if rhythm changes are noted. The registry lists secondary outcomes concerning artifact, morphology, human factors and measurable P-waves.

The primary and secondary results, analysis methods, missing-data handling and analysis populations are not reported in the registry record. The safety entry reports zero serious adverse events, zero other adverse events and zero deaths among 49 at risk.