InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology (NCT06380361), a na na study. The primary outcome is The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy..

2. Clinical Question

This is a feasibility question about obtaining a measurement in the intended procedural setting. It is not a question about whether use of the device changes a clinical outcome, and the registry record does not report evidence that would establish diagnostic accuracy or clinical benefit. The secondary outcomes concern differentiating lesion from healthy tissue and differentiating various lesion types. Their outcome values are not reported in the registry record.

3. Trial Design

NCT06380361 is a completed, single-group device study sponsored by Sensome. The registry lists the phase as NA, allocation as NA, and masking as none. All participants were assigned to the same study arm; the record does not describe a randomized or masked comparison. The listed enrollment is 30. The study start date is 2024-03-28, and the primary completion date is 2025-04-23.

The study objective is to evaluate whether the BioSpy System sensor can differentiate tissues encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses. During the procedure, the device is entered through the bronchoscope and advanced to the lesion level, where the sensor makes several measurements. The primary endpoint focuses on whether at least one non-anomalous biophysical measurement is obtained in the lesion.

The design is suited to describing device measurement feasibility in the recorded procedural context. With no separate control arm, it cannot estimate a between-group effect. The registry record does not report a protocol-level rationale for the enrollment target, detailed eligibility criteria, or a statistical analysis plan. It also does not report the number of participants in whom the device was used for the primary endpoint, beyond the endpoint definition itself.

Although the record lists the study as completed, completion status alone does not convey the results. No primary or secondary outcome values or analysis results are reported in the registry record. The described design and endpoint therefore establish what the study set out to assess, but not the frequency of successful measurements or the degree of certainty around that frequency.

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.

Population: Two participants were considered screen failures at the end of their baseline visit. One participant withdrew his consent.

6. Primary Endpoint

The registry lists the primary outcome as The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy., measured over During the bronchoscopy procedure, up to 79 minutes.

The primary endpoint measures procedural success at the participant level. Success is defined as obtaining at least one non-anomalous biophysical measurement in the lesion with the BioSpy System during bronchoscopy. The endpoint is expressed as the proportion of patients meeting that criterion among patients in whom the system was used. Its stated timeframe is during the bronchoscopy procedure, up to 79 minutes.

This endpoint is used to assess whether the device can acquire a usable measurement in the intended setting. Requiring at least one measurement makes the endpoint a threshold measure of acquisition rather than a summary of every measurement taken. It does not, by itself, quantify how often individual readings are correct, how well the device distinguishes lesion from healthy tissue, or whether readings lead to a change in care. Those are distinct questions and are not answered by the primary endpoint definition alone.

The registry record does not report the number of participants meeting the success criterion, the endpoint denominator, or an estimated proportion. It also does not report an uncertainty interval for that estimate. The endpoint is described, but its observed result and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a binary participant-level outcome: a participant either meets the stated measurement-acquisition criterion or does not. The criterion is at least one non-anomalous biophysical measurement in the lesion during the procedure. The endpoint is then expressed as a proportion among patients in whom the BioSpy System was used. This is different from treating each sensor reading as an independent observation. Several measurements may be made at lesion level, but the registry defines success at the patient level.

What does a participant-level proportion represent?

In general, a proportion is the count of participants meeting a defined outcome divided by the number of participants assessed for that outcome. Interpreting it requires both parts of that fraction and a clear outcome definition. Here, the success definition is stated, but the registry record does not report either the number meeting it or the number included in the endpoint denominator. The enrollment figure alone does not establish that all enrolled participants were included in the endpoint analysis.

A binary endpoint can be summarized as a count and a proportion. If a confidence interval is calculated, it conveys sampling uncertainty around the estimated proportion under the chosen method. In general, such an interval is not a guarantee that the true value lies within its limits, nor does it address biases caused by missing measurements, selection, or an endpoint definition that does not capture the intended construct. No interval or calculation method for the primary endpoint is reported in the registry record.

Why distinguish measurement acquisition from classification?

Obtaining a measurement and correctly differentiating tissue are not interchangeable outcomes. The primary endpoint asks whether the sensor acquires at least one non-anomalous measurement in the lesion. The stated secondary outcomes address the ability to distinguish a lesion from healthy tissue and to distinguish various lesion types. In general, an acquisition endpoint can indicate whether a measurement process is feasible, while a classification endpoint requires a reference for judging whether the distinction is correct. The registry record does not report secondary outcome results or details of a reference standard, so classification performance cannot be assessed from the outcome descriptions alone.

What does the single-group design allow?

In general, a single-group study can describe outcomes observed among participants receiving the study procedure or device. It does not provide a concurrent control group for separating the device’s performance from differences in participants, procedures, or other aspects of care. The record lists all participants in the same study arm and no masking. It does not describe a randomized comparison. Thus, a reported endpoint value would be a descriptive result for this study, rather than a direct estimate of a difference between groups.

The record lists no analysis results. It does not report a statistical model, a method for handling repeated sensor readings, an approach to anomalous measurements, or a confidence-interval method. These details matter in general because repeated readings from the same participant may be correlated. Treating correlated readings as independent can make uncertainty appear smaller than it is. A participant-level success endpoint avoids counting multiple readings as multiple participants, but it does not by itself explain how individual readings were evaluated or how missing data were handled.

How should planning calculations be read?

In general, a sample-size calculation estimates how many observations a future study might need under specified assumptions about the effect to detect, significance level, allocation, and statistical method. It is a planning exercise, not a result from participants and not an observed measure of power. The registry’s stated planning assumptions refer to a two-arm design with equal allocation and a normal approximation. This study is listed as single-group, so those assumptions do not describe its registered comparison structure. The registry record does not report a study-specific sample-size justification, and no planning calculation should be read as evidence about the study’s observed endpoint.

More generally, the choice of statistical method should reflect the endpoint and design. For a binary participant-level outcome, a suitable analysis would need to define the analysis population and account for participants whose endpoint status is unavailable. For multiple secondary outcomes, interpretation may also depend on whether the analyses were planned as separate descriptive objectives or as formal hypothesis tests. The registry record does not report those methods or results. No unadjusted recalculation can be made from the posted summary information because the primary endpoint numerator and denominator are not reported.

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("Treatment Group")
n      <- c(27)
events <- c(26)
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  Treatment Group  27  26  96.3  81.0  99.9  81.7  99.3  81.7  99.1

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists three outcome measures, including the primary endpoint and secondary outcomes concerning differentiation of a lesion from healthy tissue and differentiation of various lesion types. It reports zero analyses. No statistical analysis plan, hierarchy among secondary outcomes, or adjustment for multiple testing is reported in the registry record. In general, when several hypotheses are tested, the chance of at least one apparently notable result can increase unless the analysis plan accounts for multiplicity. That general concern does not establish that the listed outcomes were tested or that any particular adjustment was required in this study.

The registry record does not report missing-data methods, the number of participants with unavailable endpoint status, or a definition of the analysis population beyond the primary endpoint’s denominator of patients in whom the BioSpy System was used. It therefore does not show whether all enrolled participants were assessed, whether measurements were unavailable for some participants, or how any such cases were treated.

For a binary feasibility endpoint, missing status can matter because the estimated proportion depends on who is counted in the denominator and how unavailable outcomes are handled. In general, excluding participants with missing status can change the interpretation if missingness is related to procedural difficulty or measurement success. The record does not provide information to assess whether that issue arose. No imputation method, sensitivity analysis, or other missing-data analysis is reported in the registry record.

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 registry record lists a Treatment Group with 27 participants at risk for serious adverse events and zero affected. It also lists 27 participants at risk for other adverse events and zero affected, and reports zero deaths. These are the recorded safety counts and denominators. The record does not list any top serious adverse-event terms.

These figures should be read as registry entries, not as proof that no safety events occurred outside the scope of the recorded categories or reporting period. The record does not give additional detail about event definitions, collection methods, follow-up duration, or how the safety population was determined. The primary outcome timeframe is described as during the bronchoscopy procedure, up to 79 minutes; the safety follow-up period is not reported in the registry record.

The safety denominators are not the same figure as the listed enrollment of 30. The registry record does not explain why the safety risk denominators are 27 or how they relate to the enrolled population, so that relationship should not be inferred. Zero recorded events in these entries also do not answer the primary feasibility question, which concerns acquisition of a non-anomalous measurement.

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

The study asks whether the BioSpy System can obtain at least one non-anomalous measurement in a lesion during bronchoscopic biopsy. The endpoint is relevant to measurement feasibility because it describes whether the device can acquire a measurement in the intended setting. But the registry record does not report the number of participants meeting the success criterion, the number assessed for that endpoint, or an estimate of the resulting proportion.

As a result, the posted information does not establish how often measurement acquisition succeeded or how precisely that rate was estimated. The completed status does not supply the missing outcome value. Nor does the definition of the endpoint amount to evidence that the device met it.

Even if the primary result were reported, measurement acquisition would not alone establish that the sensor correctly distinguishes lesion from healthy tissue or distinguishes lesion types. Those are listed as secondary outcomes, and their results are not reported in the registry record. The record also does not establish whether measurements changed procedural decisions or affected patient outcomes.

The single-group design has no separate control arm. It can describe outcomes among participants in the study, but it cannot provide a direct comparison with an alternative approach. The registry record also does not report a statistical analysis plan, endpoint uncertainty estimate, or methods for missing data. These omissions limit assessment of the strength and scope of any possible inference.

The reported safety entries list zero serious adverse events, zero other adverse events, and zero deaths among the stated risk denominators. Those entries are descriptive and are not a substitute for detailed safety follow-up information or primary endpoint results. Overall, the registry record describes a device feasibility study and its intended measurement endpoint, while leaving the study’s observed endpoint outcomes and their precision unreported.

14. Why This Trial Matters Statistically

Feasibility endpoints can be important in device research because a device must first be able to produce the type of measurement it is designed to acquire in the intended procedural setting. This study defines a participant-level success criterion tied to obtaining at least one non-anomalous measurement in a lesion during bronchoscopy. That definition makes the practical question clear: whether measurement acquisition occurred, rather than whether every reading was accurate or whether use changed a clinical outcome.

Statistically, the distinction between a measurement-level and participant-level outcome matters. Several measurements may be taken from a participant, but the primary endpoint counts success at the participant level. This avoids equating repeated readings with separate participants when describing the endpoint. In general, repeated measurements may be correlated, so their analysis needs to reflect their structure if the question concerns the readings themselves.

The study also illustrates why design and results must be considered together. A single-group design can describe feasibility in the study setting, but it cannot estimate a contrast against a control group. The registry record’s secondary aims extend to tissue differentiation, a different statistical question from measurement acquisition. Those outcome values are not reported, and no analysis results are listed.

Finally, a clearly defined endpoint is not enough to evaluate a study’s findings. Its observed count, denominator, and uncertainty are needed to understand the result. The registry record describes the endpoint and lists the study as completed, but does not report those primary outcome results. That distinction helps prevent a study objective or endpoint definition from being mistaken for evidence of an observed outcome.

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 most immediate limitation for interpretation is that the registry record does not report the primary endpoint result. It gives the success definition but not the number of participants meeting it, the endpoint denominator, or an uncertainty estimate. It also does not report secondary outcome results, despite listing objectives related to differentiating lesion from healthy tissue and differentiating lesion types.

The record identifies a single-group design, with all participants assigned to the same arm, no masking, and no separate comparator. This limits the study to describing outcomes in its study setting and prevents a like-for-like control comparison. The registry record does not describe detailed eligibility criteria, recruitment methods, a reference standard for tissue classification, or how anomalous measurements are defined.

Important analysis details are not reported, including the statistical analysis plan, the analysis population, missing-data handling, and methods for any repeated measurements. The relationship between the listed enrollment and the adverse-event risk denominators is also not explained. The record does not report safety follow-up duration or detailed event-collection procedures.

The study is marked completed, but completion status does not resolve these limitations. The registry record does not report a study-specific sample-size justification or analysis results. Consequently, the available information is not enough to assess the precision of the primary endpoint, the performance of tissue differentiation, or the robustness of any inference.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology — NCT06380361.
• Registry record last updated 2026-04-21; status last verified 2026-03.
• Results first posted 2026-04-21.
• 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

NCT06380361 is a completed, single-group device study sponsored by Sensome, with a listed enrollment of 30. It evaluates the BioSpy System during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses. The primary endpoint is the proportion of patients in whom at least one non-anomalous biophysical measurement is obtained in the lesion among those in whom the system is used.

The study has no separate comparator and is listed as unmasked. The registry record also lists secondary outcomes concerning differentiation of lesions from healthy tissue and differentiation of various lesion types. It reports zero analyses and does not report primary or secondary outcome values, an uncertainty estimate, or missing-data methods. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths among the stated risk denominators. The study design and endpoint are described, but the outcome results are not reported in the registry record.