Feasibility Study on the VERAFEYE System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility Study on the VERAFEYE System (NCT05931835), a na na study. The primary outcome is Physician Feedback on VERAFEYE System.

2. Clinical Question

The clinical question is therefore about feasibility-related device performance and physician feedback in the context of procedures participants were already entitled to undergo. It is not a test of whether the device improves a clinical outcome relative to a comparator. Although the registry lists atrial septal defect, atrial fibrillation, atrial arrhythmia, and left atrial appendage closure among the conditions, the record does not report separate outcome results by condition or procedure type.

3. Trial Design

The registry identifies NCT05931835 as the Feasibility Study on the VERAFEYE System, sponsored by LUMA Vision Ltd. It is marked completed. The recorded start date is 2025-01-09, and the primary completion date is 2025-05-15. The registry lists enrollment as 18. That figure is the recorded enrollment; it does not establish how many participants contributed data to the physician-feedback measure.

The design is single-group, with allocation listed as NA and masking listed as none. The arm description covers subjects entitled to undergo catheter-based ablation for typical atrial flutter or atrial fibrillation, as well as subjects entitled to undergo left atrial appendage or atrial septal defect closure. The intervention is the VERAFEYE System, classified as a device. The study phase is listed as NA.

There is no control arm in the recorded design. This matters because observations from a single group cannot, by themselves, separate the system's contribution from other influences on a physician's assessment, such as the procedure context or the way feedback is elicited. The record does not report a protocol for random allocation, a comparator procedure, or a masking procedure; it records no masking.

The stated purpose is feasibility and development: the results may guide refinement of the system. The summary explicitly says the study is not designed to collect data for product approval and has no safety or efficacy endpoint. The record does not report a sample-size justification, a planned statistical analysis, or interim analyses. The recorded design should therefore be read as a single-group evaluation with physician feedback as its primary measure, rather than as a comparative clinical trial capable of estimating a treatment effect.

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: 1 of 18 enrolled subjects was classified as an intent subject (no VERAFEYE Imaging Catheter inserted into the body).

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.

Population: Procedure subjects

6. Primary Endpoint

The registry lists the primary outcome as Physician Feedback on VERAFEYE System, measured over During the procedure (up to two hours).

The primary measure is titled Physician Feedback on VERAFEYE System. It is described as the number of participants, expressed as a percentage of participants, and is collected by means of a physician questionnaire. The timeframe is during the procedure, up to two hours. The stated reason for collecting this feedback is to inform development and refinement of the system.

A percentage can describe how common a defined response is among participants who are included in the analysis. To interpret it, readers need to know what response counts toward the numerator, which participants are included in the denominator, and how incomplete questionnaires are handled. Those operational details are not reported in the registry record. In particular, the record does not define a favorable response or provide the questionnaire items, response options, or scoring rule.

The endpoint is a feedback measure, not a clinical efficacy or safety endpoint. The study summary explicitly says it is not designed to collect data for product approval and has no safety or efficacy endpoint. A numerical feedback result is not reported in the registry record, so the frequency or distribution of physician responses cannot be described from the recorded information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The recorded primary measure is a participant percentage. In general, a percentage for a binary outcome is formed by identifying participants who meet a prespecified event definition and relating that count to the number of participants assessed. The event definition is essential: different questionnaire responses could produce different percentages. The registry record does not report a response threshold, a scoring rule, or the questionnaire wording, so the endpoint cannot be reconstructed from its description alone.

In general, an estimate of a percentage is more informative when accompanied by its denominator and a measure of uncertainty. A confidence interval gives a range of values compatible with the observed data under the assumptions of the method. It communicates precision, rather than the probability that a particular value is true. A narrow interval generally indicates greater precision than a wide interval, but its interpretation depends on the analysis and data quality. No primary percentage or confidence interval is reported in the registry record, so the precision of physician feedback cannot be assessed.

For a binary percentage, methods for estimating uncertainty typically rely on the number meeting the event definition and the number assessed. Different interval methods can behave differently, especially when the event is uncommon or the sample is limited. The registry record does not specify an interval method or provide the counts needed to compare methods. This is a general statistical consideration, not a description of an analysis reported for this study.

The record lists enrollment as 18, but that does not establish the denominator for the primary outcome. In general, the enrolled group, the group that undergoes a procedure, and the group with an evaluable questionnaire may not be identical. A clear analysis should state which participants are included and how missing questionnaire responses are handled. Neither the primary endpoint denominator nor an analysis population is reported in the registry record.

The single-group design calls for descriptive interpretation rather than a randomized between-group contrast. In general, a one-group percentage can describe the observed responses in that group, provided the outcome and denominator are defined. It cannot by itself estimate a difference attributable to the device, because there is no concurrent comparator to show what feedback or outcomes would have occurred under another approach. The record lists allocation as NA and identifies one group, so it does not describe a randomized comparison.

The registry records no masking. In general, when participants or assessors know which device is being evaluated, expectations and context can influence subjective assessments. Physician feedback is elicited by questionnaire, so the way questions are framed and responses are classified may affect the resulting measure. The record does not report procedures to reduce such influences, a validated questionnaire, or an assessment of agreement between respondents. These are considerations for interpreting subjective feedback, not claims that bias occurred.

The planning framework attached to the study uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the target effect in relation to a fraction of the observed effect. In general, a planning calculation asks what sample size would be needed under stated assumptions to detect a specified effect. Its output depends on the assumed event frequency, effect size, allocation, significance level, and power target. The record's two-arm equal-allocation assumption does not match the listed single-group design. Planning figures based on these assumptions are illustrations, not a description of the study's actual design and not observed power. The record does not report the feasibility study's own sample-size justification or a planned power calculation.

A significance test would require a defined hypothesis and an analysis appropriate to the data. The registry record does not report a hypothesis test or analysis method, and it lists 0 analyses. No test statistic or p-value for physician feedback is reported. Consequently, there is no basis in the record to assess statistical significance, and statistical significance would not in any case answer whether the feedback measure captures a clinically meaningful or practically useful aspect of system performance.

Because the outcome is feedback collected during a procedure, the timing also matters. The record specifies the timeframe as during the procedure, up to two hours, but does not report when the questionnaire is administered within that interval or whether responses are collected at a single point or across the procedure. In general, a consistent assessment window helps make responses interpretable, especially when procedural experiences vary. The available description does not establish how timing was standardized.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies one outcome measure and lists 0 analyses. It does not report a statistical analysis plan, a prespecified hypothesis, or a testing strategy. Accordingly, there is no reported account of whether any statistical tests were planned, whether tests would be one-sided or two-sided, or how multiple tests would be handled. The study's stated purpose is development and refinement through physician feedback, rather than formal efficacy testing.

Multiplicity arises when several outcomes, time points, subgroups, or comparisons are tested or examined. In general, repeated testing can increase the chance of finding an apparently notable result even when no real difference exists. A prespecified approach can clarify which outcomes are primary and how secondary or exploratory analyses are interpreted. The record lists one outcome measure, but it does not report whether the questionnaire includes multiple items or how those items would be summarized. No multiplicity adjustment is reported in the registry record.

Missing-data handling is also not reported in the registry record. There is no stated number of completed questionnaires, no account of partial responses, and no description of exclusions or imputation. For a percentage, incomplete data can affect both the numerator and denominator, depending on how the endpoint is defined and how missing responses are treated. Without those details, the potential effect of missingness on the endpoint cannot be assessed.

The analysis population is not reported in the registry record. The recorded enrollment is 18, but the record does not say which participants were included in the primary outcome analysis or whether all enrolled participants contributed an assessment. It also does not describe a protocol-defined analysis set. These omissions restrict interpretation of both the endpoint denominator and the representativeness of any possible feedback estimate.

11. 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 safety figures list the Catheter-ablation Arm, with 17 participants at risk. The record reports 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths in that listed group. These are the recorded counts; they should not be expanded into a claim about unreported participants or procedure groups.

The denominator matters when reading event counts. Here, the listed at-risk group is specific to the catheter-ablation arm. The registry record does not give corresponding safety figures for a closure group, and it does not report the observation period used for these safety summaries. The serious-event term list is empty, so no serious adverse-event terms are listed.

Zero recorded events in a group does not establish that an event is impossible or that risk is absent. In general, an event count is a description of what was recorded in the defined group and observation period; its precision depends on the amount of follow-up and the completeness of event ascertainment. Those details are not reported in the registry record. Further, the study summary says the study was not designed to collect data for product approval and had no safety or efficacy endpoint. The safety counts should therefore be read as limited descriptive reporting, not as a comprehensive safety evaluation.

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

The record shows that the study was designed as a feasibility evaluation of the VERAFEYE System and that physician feedback during a procedure was the primary measure. It also records a completed study and reports safety counts for the listed catheter-ablation group. These registry entries describe the study's purpose and the information entered in the registry; they do not establish a clinical benefit or a comparative effect.

The registry does not report the numerical primary outcome. Therefore, it is not possible to say what percentage of participants or physicians gave a particular response, whether feedback was positive or negative, or how precise any estimate was. The questionnaire definition and response rule are also not reported. The absence of these details prevents interpretation of the direction and magnitude of the feedback result.

The study has no comparator group, and the registry lists no masking. Even if a descriptive feedback result were available, it could not establish how feedback would differ with another system or without the device. Nor would a subjective assessment alone establish an effect on clinical outcomes. The study summary explicitly says that the study was not designed to collect data for product approval and has no safety or efficacy endpoint.

The safety entries report 0 serious adverse events, 0 other adverse events, and 0 deaths among the 17 listed as at risk in the catheter-ablation arm. These figures are bounded by the group and reporting details in the registry; they should not be treated as proof that risk is absent or as a complete assessment across all procedures. The registry record does not report observation-period details.

Overall, the record supports a narrow reading: it documents a single-group feasibility study with a physician-feedback objective and limited reported safety counts. It does not provide the primary outcome estimate, an analysis, or a control-group contrast. The findings cannot be used from this record alone to determine effectiveness, comparative performance, or comprehensive safety.

13. Why This Trial Matters Statistically

Feasibility studies address practical and developmental questions that can precede a definitive evaluation. For a device used in a procedure, physician feedback may identify aspects of use that warrant refinement. The registry states that results may guide development of the VERAFEYE System, which makes the study's objective distinct from a confirmatory efficacy trial.

The statistical distinction between description and comparison is central. A single-group study can, in principle, describe responses observed within its participants. Without a comparator, it cannot estimate a relative effect against another device or procedure. That design feature remains important even if a feedback percentage is eventually reported. The registry lists no analysis, so the record does not contain a numerical estimate to interpret.

The record also illustrates why outcome definitions and denominators matter. A percentage of participants is interpretable only when the event or response counted is clear and the analysis population is specified. For physician feedback, questionnaire wording and scoring determine what the percentage represents. Those details are not reported in the registry record, nor is a primary outcome denominator.

Finally, the safety counts are useful as recorded descriptive information, but they do not turn the study into a safety evaluation. The summary explicitly states that there is no safety or efficacy endpoint. Reading design, endpoint, denominator, and analysis together prevents a feasibility objective or an unreported percentage from being mistaken for evidence of clinical effect.

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 most immediate limitation is that the registry record does not report a numerical primary outcome or any statistical analysis. The primary measure is described as physician feedback expressed as a percentage, but its numerator, denominator, response rule, and uncertainty are not reported. Readers therefore cannot assess the amount or precision of the feedback result.

The measure depends on a questionnaire, yet the record does not provide its items, response options, scoring method, or administration details beyond the during-procedure timeframe of up to two hours. It does not report whether the instrument was validated or how incomplete responses were treated. Without those details, the construct represented by a percentage is unclear.

The single-group design has no control condition, and masking is listed as none. As a result, the design cannot separate device-related impressions from other influences or support a comparative estimate. The eligibility description spans ablation and closure procedures, but no procedure-specific outcome results are reported. It is not possible to determine whether feedback differed across these contexts.

The registry lists enrollment as 18, while the primary outcome denominator and analysis population are not reported. Safety figures are listed for a catheter-ablation group with 17 at risk, but the record does not give an observation period or corresponding safety figures for other procedure contexts. The study summary also states that safety and efficacy were not endpoints. These limitations mean that the record is informative about the feasibility objective and design, but does not support broad conclusions about performance, comparative effect, or safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Feasibility Study on the VERAFEYE System — NCT05931835.
• Registry record last updated 2026-02-10; status last verified 2026-02.
• Results first posted 2026-02-10.
• 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

NCT05931835 is a completed, single-group feasibility study of the VERAFEYE System sponsored by LUMA Vision Ltd. The registry lists enrollment as 18, with a start date of 2025-01-09 and a primary completion date of 2025-05-15. Allocation is listed as NA, masking as none, and phase as NA.

The primary measure is physician feedback collected by questionnaire during a procedure, up to two hours, and expressed as a percentage of participants. The stated purpose is to guide system development and refinement. The study summary says it was not designed for product approval and has no safety or efficacy endpoint.

A numerical primary outcome and statistical analysis are not reported in the registry record. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths among 17 at risk in the catheter-ablation arm. The record does not report an analysis population, primary outcome denominator, or comparator group.