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 VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements (NCT06560034), a registered phase not stated study. The primary outcome is Blood Pressure.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06560034 |
| Phase | Phase not stated |
| Condition | Cardiovascular Diseases, Blood Pressure, Hypertension |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 86 |
| Arms in the primary outcome | n/a |
| Lead sponsor | 80 Beats Medical |
| Results posted | Yes |
2. Clinical Question
Population
The registry records an enrollment of 86 in a cross-sectional group. It does not report the participants’ demographic or clinical characteristics, eligibility criteria, recruitment setting, or how the enrolled group was selected. The listed conditions are cardiovascular diseases, blood pressure, and hypertension; these listings alone do not establish that every participant had any particular condition.
Intervention
The device under evaluation is VicorderCS. The record describes its non-invasive blood pressure measurement as using the common oscillometric cuff-based method. It does not report the device’s operating settings, measurement procedure, operator training, or how many readings were taken from each participant.
Comparator
The reference method is auscultation using a Korotkoff sounds device, with readings made by human observers. The record does not give further details about the reference equipment, observer number or qualifications, observer blinding, or how differences between observers were handled.
Primary question
The primary outcome is a mean difference, in mmHg, between VicorderCS non-invasive blood pressure measurements and the auscultation method. In general, a comparison of measurement methods asks how closely the device readings agree with a reference procedure. The registry does not specify the direction of subtraction, which blood pressure component or components were assessed, or the numerical mean difference and its variability. Therefore, the clinical question is identifiable, but the registry record does not show the result needed to judge the observed agreement.
3. Trial Design
The registry identifies NCT06560034 as a completed validation study sponsored by 80 Beats Medical. Its title concerns the ability of VicorderCS to capture blood pressure measurements. The intervention is the VicorderCS device, and the only described group is a cross-sectional group whose description refers to blood pressure readings from one group of participants. Enrollment is 86. The record lists a primary completion date of 2025-07-10 and a start date of 2024-08-15.
This is not described as a randomized comparison between treatment groups. The record gives no randomized allocation, and its own note cautions that the arms are not a like-for-like control comparison. The design is instead presented as a comparison of two measurement approaches: VicorderCS and auscultation using a Korotkoff sounds device with human observers’ readings. The participants are therefore the subjects of measurement, not evidence of separate device and control groups assigned to different interventions.
The registry lists one continuous primary outcome, expressed as a mean difference in mmHg, with a timeframe of 1 Day. It does not explain whether the measurements were obtained during a single visit, how readings were paired, how the timing or order of the methods was managed, or whether repeat measurements were made. These details matter because method comparisons depend on consistent measurement conditions and a clear pairing structure.
The record does not report eligibility criteria, recruitment procedures, masking, protocol deviations, or a statistical analysis plan. Although the study status is COMPLETED, the registry record does not report the numerical primary outcome or an analysis. Completion status indicates the recorded status of the study; by itself it does not supply evidence about measurement agreement or the precision of the estimate.
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.
Before assignment: As described further in the following section on recruitment methods, participants will be sent an email providing information on the study and providing steps to enroll. Members who respond to recruitment emails will be directed to a link where they can schedule their study time and sign a consent form. They will have the opportunity to contact study personnel with questions if necessary. During "sign up", participants will be taken through a questionnaire to collect relevant information.
Overall Study
| Stage | Cross-Sectional |
|---|---|
| STARTED | 86 |
| COMPLETED | 86 |
| 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 | Cross-Sectional |
|---|---|---|
| Participants analysed | 86 | |
| Age, Continuous | Years | 40.2 (SD 16.23) |
| Sex: Female, Male: Female | Participants | 44 |
| Sex: Female, Male: Male | Participants | 42 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 86 |
6. Primary Endpoint
The registry lists the primary outcome as Blood Pressure, measured over 1 Day.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is described as a mean difference between blood pressure measured by VicorderCS and blood pressure measured by auscultation with a Korotkoff sounds device and human observers. The unit is mmHg, the summary parameter is a mean, and the listed timeframe is 1 Day. The registry does not specify which blood pressure component or components the endpoint covers, the direction used to calculate the difference, or the precise reading-level procedure.
In general, a mean difference is useful for assessing whether one measurement method tends, on average, to give higher or lower readings than a reference method. A small average difference can be informative, but it does not by itself show how close individual paired readings are. Variation around the mean difference and the distribution of individual differences are also important when judging agreement between methods. This is distinct from testing whether two groups differ after receiving different treatments.
The endpoint is relevant to a device validation question because it directly compares the device’s readings with readings from the stated reference approach. However, the numerical mean difference and standard deviation are not reported in the registry record, and the direction of subtraction is not specified. The registry therefore identifies what the endpoint is intended to measure, but does not provide the result or enough detail to interpret the magnitude and direction of any observed difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed study of VicorderCS blood pressure measurement against auscultation readings made with a Korotkoff sounds device and human observers. It lists a mean difference in mmHg as the primary outcome. Those details establish the broad measurement question, but they do not establish what the study found. The numerical endpoint result, its standard deviation, and an analysis are not reported in the registry record.
Without the estimated mean difference, it is not possible to describe whether VicorderCS readings were higher or lower on average than the reference readings, or how large the average difference was. The registry also does not specify the subtraction direction, so even a reported signed estimate would need that definition for interpretation. The reported endpoint is a mean; it would not, on its own, describe the spread of differences across participants or the closeness of individual device readings to reference readings.
In general, a confidence interval describes the range of values compatible with an estimate under the statistical model and conveys uncertainty about its precision. The registry record does not report an interval for the primary endpoint. Consequently, the precision of the estimated difference cannot be assessed from the recorded outcome information. Nor does the record provide a test statistic or p-value for this endpoint. It is not appropriate to infer statistical significance, equivalence, or acceptable agreement without the estimate, uncertainty information, and a prespecified criterion for interpreting the difference.
The enrollment of 86 describes the recorded study enrollment, not the number of paired observations available for the endpoint. The analysis population and completeness of the measurements are not reported. It is therefore not possible to determine from the registry record how many participants contributed usable paired readings, whether any readings were excluded, or how missing measurements were handled.
The record contains a sample-size planning description based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. Those assumptions describe a planning illustration rather than the actual cross-sectional measurement design. The stated effect is a fraction of the observed effect, but the registry record does not report the endpoint estimate needed to evaluate such an illustration. Any sample-size figures should be read as planning scenarios, not as observed power or as evidence that the study was designed with that allocation.
Overall, the registry supports a description of the intended comparison and its endpoint, but not a conclusion about the observed agreement. The distinction is important: a completed status and a defined outcome do not substitute for posted endpoint results. The findings, if reported elsewhere in a complete analysis, would need to be interpreted using the measurement procedure, paired-data structure, uncertainty, and an appropriate standard for acceptable agreement. Those details are not reported in the registry record.
9. Statistical Methods Explained
The listed primary outcome is continuous and summarized as a mean difference. Understanding that choice helps clarify what the endpoint could show, while also making clear what is absent from the registry record. The record identifies the comparison methods and measurement unit, but does not report a numerical estimate, standard deviation, confidence interval, or analysis.
What does a mean difference represent?
In general, a mean difference summarizes the average of paired differences between two measurements. For this study, the stated pair is a VicorderCS measurement and an auscultation measurement made with a Korotkoff sounds device and human observers. A positive or negative value would depend on the subtraction order, so the direction must be specified before the sign can be interpreted. The registry record does not state that order or provide the value.
A mean difference addresses average bias: whether one method tends to read higher or lower than the other across the measurements included in the analysis. It is not the same as a measure of how closely every individual pair agrees. In general, readings can have a mean difference near zero while individual paired differences remain widely dispersed. Conversely, a consistent average offset can coexist with relatively little variation around that offset. The mean therefore needs to be considered alongside measures of dispersion and, for a method-comparison question, information about individual differences.
Why does the standard deviation matter?
In general, a standard deviation describes variation in the observations being summarized. The endpoint lists standard deviation as its dispersion measure, but the numerical standard deviation is not reported in the registry record. The record also does not clarify whether this dispersion refers to individual readings, paired differences, or another quantity. That definition is important: variability among paired differences speaks more directly to how consistently the two methods agree across participants than variability in either method considered separately.
In general, over-dispersion means that observed variability is greater than a statistical model assumes. When a method-comparison analysis treats readings as more independent or less variable than they are, uncertainty may be understated. Repeated readings from the same participant can be correlated, and paired measurements require analysis that respects their within-participant relationship. The registry does not report whether there were repeated readings or how any correlation was handled, so no specific modeling approach can be attributed to this study.
What would uncertainty estimates add?
In general, a confidence interval accompanies an estimate by showing its statistical uncertainty under the chosen analysis. A narrow interval indicates more precise estimation than a wide interval, though precision does not establish that a method is acceptable. For a device validation question, interpretation also depends on an agreed criterion for acceptable differences and on whether the uncertainty range is compatible with that criterion. The registry record reports neither an interval nor an acceptance threshold. A p-value, if available, would address a different question about compatibility with a specified null model; it would not by itself establish practical agreement between measurement methods.
The registry lists a mean and standard deviation but does not include the corresponding numerical results or describe a confidence-interval method. It also does not identify an equivalence or non-inferiority margin. Without those elements, there is no basis in the registry record for classifying the observed performance as acceptable or unacceptable, or for quantifying how precisely the endpoint was estimated.
How should the planning assumptions be understood?
The record describes a sample-size planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It distinguishes participant counts per arm from total event counts for time-to-event settings. These are assumptions for a hypothetical planning exercise; they do not describe the recorded cross-sectional comparison of measurement methods. The record’s design note explicitly cautions that its arms are not a like-for-like control comparison.
In general, a planning calculation asks what sample size would be needed to detect an assumed effect under specified statistical conditions. Its result depends on the effect size and variability assumptions, among other design choices. A calculation based on an observed effect is retrospective as a planning illustration and does not establish the study’s original design rationale. It is not observed power. The registry does not report the protocol’s sample-size justification, the original design assumptions, or whether any interim analyses were planned.
Because the numerical observed endpoint result is not reported in the registry record, the effect used for the planning illustration cannot be evaluated from the registered outcome information. The illustrative assumptions should not be mistaken for a randomized two-arm design, a prespecified protocol analysis, or evidence about the precision of the study’s actual measurement comparison. No recalculated endpoint analysis can be described from the registry record because the necessary summary statistics and result are absent.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure, a continuous mean difference in mmHg, and records 0 analyses. This describes what is registered, not necessarily every analysis that may have been planned or conducted. The registry record does not report whether there were additional endpoints, secondary analyses, subgroup comparisons, or multiple versions of the primary outcome outside the listed measure.
In general, multiplicity arises when several statistical tests or outcome comparisons are considered together. Repeated testing can increase the chance of a false-positive finding if no suitable strategy is specified. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a statistical analysis plan. It is therefore not possible to determine whether multiplicity was relevant to the full study analysis or how it was addressed.
The record does not report missing-data counts, the number of participants with paired readings, exclusions, or the methods used to handle incomplete measurements. Enrollment of 86 should not be treated as confirmation that every enrolled participant contributed to the primary analysis. In general, missingness can affect an estimate if availability of measurements is related to readings or participant characteristics. Without information about completeness and handling, the potential effect cannot be assessed.
The analysis population is also not described. The registry does not state whether the endpoint was analyzed in all enrolled participants, only those with complete paired measurements, or another defined population. It does not report protocol deviations or rules for excluding measurements. These omissions limit assessment of how the registered endpoint would have been constructed and which observations would contribute to it.
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 |
|---|---|---|---|
| Cross-Sectional Group | 0 | 86 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cross-Sectional Group | 0 of 86 |
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 |
|---|---|
| Cross-Sectional Group | 0 of 86 |
The registry’s safety summary lists the cross-sectional group with 86 at risk for serious adverse events and 0 affected. It also lists 86 at risk for other adverse events and 0 affected, with 0 deaths. These are the recorded figures for the group; they are not a comparison of randomized treatment arms.
In general, an at-risk count identifies the group for which an event summary is recorded, while an affected count records participants reported with the relevant event category. A zero in the affected column means that no events in that category are recorded in this summary. It should not be interpreted as proof that the device has no risks or that an event is impossible. The registry does not report the event-collection period, the definitions used, monitoring procedures, or whether the summary covers every event of interest.
The record lists no serious adverse event terms. Without further information about ascertainment and reporting, the safety figures should be read as a registry summary rather than as a complete characterization of device safety. They do not resolve the primary measurement-agreement question, and they do not provide comparative safety evidence against a control group.
12. What the Result Does, and Does Not, Mean
The record describes a device validation question: whether VicorderCS blood pressure readings differ on average from auscultation readings made with a Korotkoff sounds device and human observers. It identifies the primary outcome as a mean difference in mmHg and marks the study COMPLETED. These registry entries establish the study’s general purpose and status, but they do not reveal the magnitude, direction, or precision of the observed difference.
The numerical primary result is not reported in the registry record. The record also does not report a confidence interval, numerical standard deviation, or analysis. As a result, the posted information cannot establish how close the methods were on average, how variable paired readings were, or how precisely the difference was estimated. Because the direction of subtraction is also unspecified, even the sign of a reported difference would require further methodological detail for interpretation.
In general, agreement between measurement methods is not established merely by failing to detect an average difference. A useful evaluation needs to consider the distribution of paired differences, appropriate uncertainty estimates, and a prespecified standard for acceptable agreement. The registry does not report such a standard. Nor does a mean difference alone reveal whether individual readings are close enough for the intended measurement context.
The enrollment of 86 does not show how many complete paired measurements were analyzed. The record does not report missing-data handling or define the analysis population. It also does not describe measurement repetition, timing, observer procedures, or the handling of repeated readings. These unknowns make it difficult to assess the precision and reproducibility of any result, even if the primary estimate were available.
The safety summary records 0 serious adverse events, 0 other adverse events, and 0 deaths in the listed group. Those entries are limited to the registry summary and should not be treated as proof of no risk. Taken together, the record supplies an outline of the study question but not enough endpoint or methods information to support a conclusion about validation performance or safety.
13. Why This Trial Matters Statistically
Measurement validation asks a different statistical question from a treatment-effect trial. The central concern is whether measurements from a device align sufficiently with a reference method, not whether participants assigned to one treatment have better outcomes than participants assigned to another. The registry identifies this distinction through a single cross-sectional group and a mean-difference endpoint comparing VicorderCS with auscultation readings.
This distinction matters because a mean difference is only one part of agreement assessment. In general, average bias and the spread of individual paired differences answer complementary questions. A method can have little average bias while producing substantial differences for some participants. A sound interpretation therefore needs information about variability, uncertainty, the paired measurement procedure, and the standard used to judge acceptable agreement.
The registry record makes the intended endpoint recognizable, but does not report its numerical result, an analysis, or an acceptance criterion. That gap illustrates an important issue in registry interpretation: registration of an outcome and completion of a study do not make the evidence available for evaluating the outcome. Readers can identify what was intended to be measured, but cannot determine what the measurements showed from the registry record alone.
The planning description also illustrates why design context matters. Its assumptions refer to equal allocation between two arms and an effect based on the observed effect, whereas the registered study description is a single-group measurement comparison and cautions against treating the arms as like-for-like controls. Planning calculations can help explore hypothetical future designs, but they are not evidence of observed precision or the study’s original sample-size rationale.
Finally, the missing analysis-population and measurement-procedure details matter especially for a device study. Pairing, repeated readings, operator practices, and complete-case selection can affect the meaning and uncertainty of a mean difference. The registry leaves these matters unreported. The record is therefore useful for identifying the validation question and the broad comparison, while its limitations prevent a statistical judgment about the device’s measured agreement.
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 registry record gives limited detail about the participants. It reports enrollment of 86 and lists cardiovascular diseases, blood pressure, and hypertension, but does not provide eligibility criteria, demographic characteristics, clinical profiles, recruitment setting, or selection procedures. The applicability of any measurement findings to other groups therefore cannot be assessed from the registry description.
Important measurement procedures are not reported. The record does not specify the blood pressure component or components assessed, the order of the VicorderCS and auscultation measurements, the interval between readings, whether measurements were repeated, or how paired readings were formed. It also does not state the direction used to calculate the mean difference. Such details are central to interpreting a comparison of measurement methods.
The reference procedure is described as a Korotkoff sounds device with human observers’ readings, but the equipment details, observer number, training, blinding, and approach to observer disagreement are not reported. Device settings and operator procedures for VicorderCS are also not given. This limits evaluation of reproducibility and the possibility that measurement procedures influenced the comparison.
The numerical primary result and analysis are not reported in the registry record. There is no numerical estimate, standard deviation, confidence interval, or reported statistical analysis. The record also does not specify an acceptable-agreement threshold, analysis population, completeness of paired measurements, missing-data approach, or exclusions. The planning illustration’s assumptions should not be taken as a substitute for a protocol sample-size justification or the design of this measurement study.
Finally, the registry’s serious adverse event summary does not describe event definitions, collection period, or monitoring procedures. The zero counts should be interpreted only as the recorded summary. Together, these omissions mean that the registry record identifies the study’s aim but does not permit a full assessment of its measurement methods, statistical precision, applicability, or safety reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements — NCT06560034.
- Registry record last updated 2026-06-29; status last verified 2026-06.
- Results first posted 2026-06-29.
- 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
NCT06560034 is a completed, cross-sectional validation study sponsored by 80 Beats Medical. The registry records enrollment of 86, a start date of 2024-08-15, and a primary completion date of 2025-07-10. VicorderCS non-invasive blood pressure measurements are compared with auscultation readings made using a Korotkoff sounds device and human observers.
The listed primary outcome is a mean difference in mmHg, with a timeframe of 1 Day. The numerical outcome, standard deviation, analysis, and analysis population are not reported in the registry record. Measurement procedures and an acceptable-agreement criterion are also not described. The record’s sample-size assumptions concern a planning illustration, not the stated cross-sectional comparison. The safety summary lists 0 serious adverse events, 0 other adverse events, and 0 deaths in the cross-sectional group. Overall, the record defines the broad measurement question but does not report enough endpoint information to interpret the observed agreement.