A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease (NCT04960280), a na na study. The primary outcome is The Number of Subjects Who Completed Baseline Testing With the ©VoqX Stethoscope.

2. Clinical Question

These are related but distinct questions. Completion can describe whether baseline device testing was recorded as completed, while comparison with clinical tests would require diagnostic results and an analysis of how the findings correspond. The registry lists one outcome measure and no analyses. It does not report the number who completed baseline testing, or an accuracy or agreement estimate. Consequently, the stated diagnostic aim provides context for the study, but the posted primary outcome alone cannot answer it.

3. Trial Design

The registry describes a completed, single-group device study sponsored by Mayo Clinic. The intervention is the ©VoqX stethoscope, classified as a device. The listed enrollment is 400. The study is not randomized: allocation is recorded as NA, and masking is recorded as none. The record therefore does not describe a randomized, masked comparison between treatment groups.

Participants are described as presenting for routine, clinically indicated echocardiography or routine, clinically indicated catheterization. They would undergo computerized auscultation using the device. These routine clinical tests provide the context for the study's stated interest in whether the device's heart-sound abnormalities are similar to those shown by echocardiogram or catheterization. The available record does not specify the exact sequence or timing of the procedures, whether every participant underwent the same reference test, or how the diagnostic findings were compared.

The primary outcome is the number of participants who completed baseline diagnostic testing with the device. Its timeframe is baseline. Although the record gives the enrollment and an outcome definition, it does not report the observed completion count. It lists one outcome measure and zero analyses. The device's comparison with echocardiography or catheterization is described as the study purpose, but no numerical diagnostic comparison is posted.

The study status is completed. Its recorded start date is 2021-09-03, and its primary completion date is 2024-05-02. The phase is listed as NA. Further information about the recruitment process, eligibility rules, follow-up, protocol-defined analysis populations, or sample-size justification is not reported in the registry record. As a single-group study, it can describe what was recorded in the enrolled group, but the record does not establish a randomized between-group treatment contrast.

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 The Number of Subjects Who Completed Baseline Testing With the ©VoqX Stethoscope, measured over Baseline.

The registered primary endpoint counts participants who completed baseline diagnostic testing with the ©VoqX stethoscope. It is a count of participants, with the timeframe identified as baseline. The endpoint is therefore a measure of whether baseline device testing was completed, rather than a direct measure of whether the device correctly identified a cardiac condition.

Completion is useful because it describes whether the intended baseline assessment was carried out. For a device study, this can help show whether the planned measurement was obtained in the study setting. However, an endpoint based on completion does not, by itself, tell readers how often the device detected an abnormality, whether its findings agreed with echocardiography or catheterization, or how precisely any diagnostic classification was estimated.

The study's broader purpose refers to similarity between computerized auscultation findings and abnormalities identified by echocardiogram or cardiac catheterization. That broader question would require reported diagnostic findings and a suitable comparison analysis. The registry record does not report such an analysis. It also does not report the observed count for the primary endpoint. The enrolled number should not be read as the number who completed testing; the actual completion result is not reported in the registry record.

Because no result for this endpoint is posted, readers cannot use the primary outcome to estimate completion in the study group from this record. Nor can the endpoint resolve the diagnostic question on its own. The posted definition tells readers what was intended to be counted, but the result and any accompanying uncertainty are not reported.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record labels the study as single-group and gives no randomized allocation. In general, a single-group study observes participants receiving or undergoing the study procedure without random assignment to a separate control group. Here, the recorded intervention is computerized auscultation with the ©VoqX stethoscope. The record also says masking is none. These design features describe how the study is organized; they do not supply evidence about the diagnostic performance of the device.

What the primary outcome counts

The primary outcome is a participant count: those who completed baseline diagnostic testing with the device. A count is a descriptive outcome. To interpret it, readers need the observed count and a clear account of the denominator and analysis population. The registry gives enrollment as 400, but it does not post the completion count or further define the population used for that count. Enrollment and completion are different concepts, so one cannot be substituted for the other.

For a binary outcome, the underlying status for each participant can be thought of as whether the event of interest occurred or did not occur. In general, a count can be summarized alongside its denominator, and a proportion can also be reported. No additional proportion should be inferred: the completion result is absent, and the posted outcome is defined as a count. The record gives no confidence interval or other uncertainty measure for this endpoint.

What a comparison would require

The study purpose refers to similarity between abnormalities recorded by the device and those found by echocardiogram or cardiac catheterization. In general, diagnostic comparison requires paired or otherwise appropriately linked findings, a defined reference standard, and a prespecified measure of correspondence or accuracy. The choice of measure depends on the question and on how results are categorized. The record does not describe these details or post an analysis. It would therefore be inappropriate to reconstruct a diagnostic comparison from the stated study purpose alone.

In general, sensitivity describes how often a test identifies the condition among people who have it, while specificity describes how often it classifies people without the condition as not having it. Agreement measures address correspondence between classifications, but agreement is not automatically the same as accuracy against a reference standard. These are general concepts, not results reported for this study. The registry record does not provide values for them.

Uncertainty and statistical testing

A confidence interval is a range calculated by a statistical method to convey the uncertainty around an estimate. Its interpretation depends on the estimate, the data, and the method used. A narrow interval generally indicates greater precision than a wide interval under the same framework, but neither can be assessed without an estimate and interval. Here, no analysis result or interval is listed. The record also gives no p-value for the primary endpoint or a diagnostic comparison.

Statistical significance and practical or diagnostic importance are different questions in general. A test result does not, on its own, establish that a measurement is useful, and a lack of a reported test is not evidence of either a positive or a negative finding. Since no inferential analysis is posted, the appropriate reading is that the record does not report an inferential result.

Planning calculations and the study design

The sample-size section is identified as a planning illustration computed from an observed effect, rather than the trial's own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. In general, such calculations ask how much information might be needed to detect a specified effect under stated assumptions. They do not describe how many participants actually completed testing, and they are not observed power.

The illustration's equal-allocation, two-arm assumption should not be confused with this study's registered single-group design. It is a hypothetical planning framework, not evidence that the trial enrolled two randomized arms. The record does not report the trial's own sample-size justification, the effect estimate underlying any calculation, or an analysis plan. Since the registry lists zero analyses, the illustration cannot be used as a substitute for a posted clinical result.

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("Computerized Auscultation")
n      <- c(400)
events <- c(400)
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  Computerized Auscultation  400  400  100.0  99.1  100.0  99.0  100.0  99.1  100.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure and zero analyses. It does not describe a multiplicity adjustment, a hierarchy of outcomes, or a plan for handling multiple statistical tests. Without reported analyses, readers cannot determine whether multiple comparisons were conducted or how any such comparisons were managed. The absence of a listed adjustment should not be interpreted as evidence that multiplicity was assessed and found not to matter.

The primary outcome is described as a count of participants completing baseline testing. The record does not state how missing or incomplete baseline assessments were handled, whether participants without a recorded test were counted as not completing, or whether any imputation method was used. Those details matter because missing observations can affect both the denominator and the interpretation of a completion count. The observed completion result itself is not reported in the registry record.

Analysis populations are also not described. The record does not identify an intention-to-treat population, a per-protocol population, or another defined set of participants for the outcome analysis. These are general analysis-population concepts; the registry does not say which, if any, was used. It also does not give participant flow or explain exclusions from an analysis.

For the diagnostic aim, the record does not state how unavailable or indeterminate device readings, echocardiogram findings, or catheterization findings were handled. It does not report the pairing of test results or the analysis population for any comparison. These omissions limit assessment of both completeness and potential bias. They do not establish that data were missing; they mean that the registry record does not report how missingness and analysis populations were addressed.

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 posted adverse-event figures list the computerized auscultation group with 400 participants at risk for serious adverse events and 0 affected. For other adverse events, the listed number at risk is 400 and the number affected is 0. The recorded number of deaths is 0. No serious adverse-event terms are listed.

These are registry counts, not comparative estimates. Because the study is single-group and no control group is reported, these figures do not provide a randomized comparison of safety between groups. The record does not provide event rates with uncertainty estimates, details about event definitions, or information about the period and procedures used for event collection. The figures should therefore be read narrowly as the adverse-event counts posted for this group.

A recorded count of 0 means that no events are listed in that category in this entry. It does not demonstrate that the possibility of an event is absent, establish complete ascertainment, or answer questions about events not described in the record. The registry also does not list specific non-serious event terms. Further safety context is not reported in the registry record.

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

The posted record establishes that this was a completed, single-group study of computerized auscultation using the ©VoqX stethoscope, with routine echocardiography or cardiac catheterization as the setting for the stated diagnostic question. It identifies the number completing baseline device testing as the primary outcome. It does not report the result for that outcome, and it lists zero analyses.

As a result, this registry entry does not allow readers to quantify how many participants completed the baseline test or how closely device findings corresponded to findings from echocardiography or catheterization. It does not provide an estimate of diagnostic accuracy, agreement, or the uncertainty around such an estimate. The broad study purpose is not itself a result. Nor should completion, even if it had been reported, be treated as proof that the device correctly classified cardiac abnormalities.

The adverse-event entry records 0 serious events, 0 other events, and 0 deaths among the listed group, with 400 at risk in each event category. These figures are descriptive and have no reported comparison or uncertainty analysis. They do not establish that all possible events were captured, and they cannot be used to infer a comparative safety effect.

More generally, a study result answers only the question measured and analyzed. Completion, diagnostic correspondence, and safety are different outcomes. The registry's stated primary endpoint concerns completion, while the summary describes diagnostic similarity as the broader purpose. Since neither a completion count nor a diagnostic analysis is posted, the record cannot show the size or precision of a diagnostic finding.

The appropriate conclusion is limited: the registry records the study design, its intended context, and selected safety counts, but not the primary endpoint result or diagnostic analysis. This is not evidence that the device succeeded or failed. Those conclusions cannot be drawn from the information.

14. Why This Trial Matters Statistically

This record illustrates why the distinction between a study aim and a registered outcome matters. The stated aim concerns whether computerized heart-sound assessment identifies abnormalities similar to those found by echocardiogram or cardiac catheterization. The primary outcome, however, is the number of participants who completed baseline device testing. Completion is relevant to whether an assessment was carried out, but it does not directly measure diagnostic correspondence.

For statistical interpretation, outcome definition and result availability are both essential. A clearly defined endpoint helps readers understand what a study intended to measure, while a posted result makes it possible to assess what was observed. Here, the endpoint is defined but its count is not reported. The registry also lists zero analyses. That gap prevents readers from assessing an estimate, its precision, or a statistical comparison.

The single-group structure is also important. It distinguishes the study from a randomized comparison and prevents readers from treating the record as evidence of a between-group treatment effect. The clinically indicated tests provide the stated reference context, but a diagnostic comparison still requires reported findings and an analysis method. Neither can be inferred solely from the design description.

Finally, the sample-size section is described as a planning illustration rather than the trial's own design. Such illustrations can explain how assumptions affect planning, but they cannot replace observed results or establish the precision of a study finding. In general, careful reading means matching each conclusion to the outcome and analysis actually reported. Here, the registry supports a description of the study structure and posted safety counts, while leaving the main completion and diagnostic results unresolved.

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 of interpreting this record is that it does not report the primary outcome result. Although enrollment is listed as 400, the number who completed baseline testing is not given. The record also lists zero analyses, leaving no posted estimate, uncertainty interval, or test result for the primary endpoint.

The diagnostic objective is not accompanied by a reported diagnostic analysis. The record does not specify how device findings were linked to echocardiogram or catheterization results, which test served as the reference for each participant, or how abnormalities and agreement were defined. It also does not report diagnostic accuracy measures. These gaps mean the broader objective cannot be evaluated from the posted results.

The design information is limited. The study is described as single-group, with allocation NA and no masking, but recruitment and eligibility details are not reported in the registry record. The available description does not establish whether participants underwent the same reference test, or provide detailed timing and procedural information. Further information about analysis populations, missing data, and participant flow is not reported.

Safety interpretation is constrained to the posted counts. The entry provides no serious adverse-event terms, no further event definitions or ascertainment details, and no comparative group. It also does not provide uncertainty estimates for the safety figures.

Finally, the sample-size material is explicitly a planning illustration, not the trial's own design justification. Its stated assumptions include equal allocation between two arms, which does not describe the registry's single-group structure. The record does not report the study's own sample-size rationale or statistical plan. Taken together, these limitations make this entry useful for identifying the study's registered structure and aims, but insufficient for judging its diagnostic results.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease — NCT04960280.
• Registry record last updated 2026-10-20; status last verified 2026-09.
• Results first posted 2026-10-20.
• 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.

19. Record Summary

This completed study evaluated computerized auscultation using the ©VoqX stethoscope in people presenting for clinically indicated echocardiography or cardiac catheterization. It is listed as a single-group study, with no masking, enrollment of 400, and a primary outcome counting participants who completed baseline device testing.

The registry's broader stated purpose is to assess whether device findings show abnormalities similar to those from echocardiogram or cardiac catheterization. However, the primary completion count is not reported, and the record lists zero analyses. It therefore provides no posted diagnostic-accuracy or agreement result. The adverse-event entry lists 400 at risk and 0 affected for serious events, 400 at risk and 0 affected for other events, and 0 deaths. The record does not provide further safety analysis or details on missing data, analysis populations, or the study's statistical plan.