Use of a New Stapling Device in General Thoracic Surgery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Use of a New Stapling Device in General Thoracic Surgery (NCT05143541), a registered phase not stated study. The primary outcome is Number of Participants With Product Malfunction.

2. Clinical Question

Statistically, the endpoint is a participant count rather than a continuous measurement or a time-to-event outcome. It is intended to describe whether the specified device problem occurred among participants during the stated timeframe. The record also lists hospital length of stay and chest tube removal as secondary outcomes, but their results are not reported in the registry record. Without a reported primary endpoint result, the record does not establish the observed frequency of product malfunction or how precisely that frequency was estimated.

3. Trial Design

The study is registered as completed, with a listed enrollment of 80. Its start date is 2021-03-01 and its primary completion date is 2021-09-30. The stated purpose was to test the safety and efficacy of the AEON Endostapler in a general thoracic surgery practice. The intervention is a device, and the listed arm description specifies stapling with that device.

The registry lists no comparator arm. Allocation is not stated, and the record does not describe a randomized comparison. Consequently, this record should be read as a report about device use in the listed setting, not as a head-to-head estimate against another stapler or surgical approach. Any planning assumptions that describe equal allocation between two arms belong to a sample-size illustration; they do not establish that the trial itself used two arms or randomized participants.

The primary endpoint is the number of participants with product malfunction during surgery, with a timeframe of within surgery, up to 8 hours. The registry defines malfunction as any occurrence during surgery in which the stapler does not perform as intended. Hospital length of stay and chest tube removal are listed as secondary outcomes. The record lists 5 outcome measures, but detailed results for the primary and secondary outcomes are not reported in the registry record.

The registry lists 0 analyses. That does not supply a statistical analysis plan or an account of how observations were handled. Details such as eligibility criteria, enrollment flow, participant characteristics, device-use procedures beyond the arm description, follow-up beyond the stated primary timeframe, and the rationale for the enrollment target are not reported in the registry record. The listed enrollment should not be mistaken for a reported denominator for the primary endpoint, since the analysis population and endpoint result are not given.

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 Number of Participants With Product Malfunction, measured over Within surgery, up to 8 hours.

The primary endpoint counts participants with product malfunction. The registry’s definition is tied to the device’s intended performance: a malfunction is any occurrence during surgery in which the stapler does not perform as intended. The specified timeframe is within surgery, up to 8 hours. This makes the endpoint a binary event at the participant level: a participant either meets the stated malfunction definition during the timeframe or does not. The endpoint is then expressed as a count of participants.

Such an endpoint is used to describe a specific device-performance concern in the setting where the device is used. A clearly defined event and timeframe help readers understand what is being counted and which observations would qualify. The count alone, however, does not show the rate or uncertainty unless the relevant analysis denominator and an estimate of precision are also reported. A confidence interval, when available, describes the range of values reasonably compatible with the data under the statistical method used; it does not resolve problems caused by incomplete outcome reporting or an unclear analysis population.

The registry record does not report the primary endpoint count, an analysis denominator, or a confidence interval. The posted adverse-event counts are not a substitute for this endpoint: serious adverse events and product malfunction are different measures, and the record does not say that they are interchangeable. Accordingly, the primary endpoint’s observed frequency and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record gives endpoint definitions and some event counts, but it does not report an inferential statistical analysis. The concepts below explain how such data are generally interpreted; they are not claims about methods used in this study.

What does a participant count measure?

For a binary endpoint, each participant is classified according to whether the event definition was met during the stated timeframe. The endpoint can then be reported as the number of participants with the event, along with the number assessed. Here, the primary endpoint is the count of participants with product malfunction during surgery, up to 8 hours. The record defines the event but does not report the count or the primary analysis denominator. As a result, the endpoint’s observed proportion cannot be read from the registry record.

A count and a proportion answer related but different questions. A count conveys how many events were recorded in the analyzed group; a proportion relates that count to the number of participants assessed. The denominator matters because the same count can imply different levels of uncertainty in groups of different sizes. A denominator should refer to the participants actually included in that endpoint analysis, not simply the number enrolled, unless the record confirms they are the same. That confirmation is not reported in the registry record for this endpoint.

What would a confidence interval add?

In general, a confidence interval describes statistical uncertainty around an estimate under a specified method and its assumptions. For a binary outcome, it can communicate how uncertain an estimated event proportion is, especially when the observed count is small. It does not describe every source of uncertainty: it cannot correct an imprecise event definition, missing outcomes, selection into the analyzed group, or limitations in how events were detected. No confidence interval for the primary endpoint is reported in the registry record.

A reported zero count also needs careful interpretation. In general, observing no recorded events is not the same as demonstrating that the underlying event probability is exactly zero. The interpretation depends on the number assessed, how complete observation was, and the event ascertainment process. Those details are not reported for the primary endpoint. The adverse-event entries list zero affected for the reported categories, but they do not supply the missing product-malfunction result.

Why does the comparator matter?

A treatment or device comparison requires groups that can be meaningfully contrasted, along with a design and analysis that address differences between them. Random allocation is one general way to reduce systematic differences between groups, although its use and implementation must be documented. This record does not describe a randomized comparison, its allocation is not stated, and no comparator group is listed. Thus, the registry record does not offer a comparative effect estimate. A count in the AEON group, even if reported, would describe that group rather than show what would have happened under another device or approach.

What is over-dispersion?

In general, over-dispersion occurs when observed variability in count data exceeds what a simple statistical model assumes. It can make standard errors too small and confidence intervals too narrow if the model fails to allow for that extra variability. This issue can arise in some count-data analyses, but the primary endpoint is registered as a participant count for a binary event, not as a repeated event rate. The record reports 0 analyses and does not describe a statistical model, so there is no basis for saying over-dispersion was assessed or relevant to an analysis in this study.

What do the sample-size illustrations mean?

In general, a sample-size calculation is a planning exercise: it describes the group size that a specified design might require to detect a stated effect under stated assumptions. It is not an observed result and is not observed power. The registered planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of an observed effect. For time-to-event planning, the stated convention is a total event count; other planning outputs are participants per arm. These assumptions do not establish the design actually used in the study. The registry record does not report the study’s own sample-size justification or a randomized two-arm design.

Because the primary outcome result is not reported, the record does not provide an observed primary effect from which readers could judge the planning illustrations. Planning values should be interpreted only as conditional illustrations under their stated assumptions, not as evidence that the study had a particular power or that an effect was detected. No analysis result is posted from which to assess statistical significance or estimation precision.

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("AEON Endostapler")
n      <- c(80)
events <- c(0)
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  AEON Endostapler  80  0  0.0  0.0  4.5  0.0  4.6  0.0  4.5

11. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study assesses several outcomes or conducts several statistical tests. In general, the more hypotheses examined, the greater the chance that at least one test will appear statistically significant by chance if each is interpreted without accounting for the set of tests. Possible approaches include prespecifying a primary outcome, controlling an error rate across tests, or treating secondary analyses as exploratory. The record identifies a primary endpoint and lists hospital length of stay and chest tube removal as secondary outcomes, but it does not report a multiplicity strategy. That strategy is not reported in the registry record.

The registry lists 5 outcome measures and 0 analyses. It does not provide test results, confidence intervals, or a statistical analysis plan describing how outcomes were prioritized or interpreted together. Therefore, there is no basis for determining whether multiplicity was addressed, whether any secondary outcome analysis was planned as confirmatory, or how any reported tests would have been adjusted. The secondary outcome results themselves are not reported in the registry record.

Missing-data handling is also not described. The record does not report whether any participants lacked primary or secondary outcome observations, how missing observations were defined, or whether any imputation or sensitivity analysis was used. It does not report the analysis populations or specify how participants were handled if the device was not used as intended or the outcome could not be assessed. These omissions matter because the denominator for an endpoint and the completeness of follow-up affect interpretation of its estimate.

The listed enrollment of 80 does not, on its own, establish that all enrolled participants were included in every outcome analysis. Nor does completed status provide information about missing outcomes. The registry record does not report the sample-size justification, interim analyses, or statistical analysis plan. Without those details and without posted endpoint analyses, the effects of missing data and multiplicity cannot be evaluated.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists 80 at risk for serious adverse events, with 0 affected. It also lists 80 at risk for other adverse events, with 0 affected, and 0 deaths. These entries describe the posted adverse-event counts for the AEON Endostapler group. They are not the result for the primary endpoint of product malfunction, which is not reported in the registry record.

In general, a count of zero means no events were recorded in the listed category for the reported group and record. It does not establish that the underlying risk is zero. Interpretation depends on event definitions, how actively events were sought, the period covered, completeness of follow-up, and the number included in the assessment. Further details on those matters are not reported in the registry record. The adverse-event entries should therefore be presented as recorded counts, not as proof that no events occurred in any broader sense.

Serious adverse events, other adverse events, deaths, and product malfunction are distinct categories. The record does not say that a malfunction necessarily counts as an adverse event, or that every adverse event would meet the product-malfunction definition. Hospital length of stay and chest tube removal are listed as secondary outcomes, but their results are not reported. The listed safety figures do not answer those outcome questions.

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

The registry record gives useful information about what the study set out to examine: use of the AEON Endostapler in general thoracic surgery, with product malfunction during surgery as the primary endpoint. It defines malfunction as an occurrence in which the stapler does not perform as intended and sets the timeframe as within surgery, up to 8 hours. The study is listed as completed, with enrollment of 80. These registry entries describe the registered study and its intended measurement.

The record does not report the primary endpoint count, its denominator, or an estimate with a confidence interval. It therefore does not show the observed frequency of product malfunction or the precision of that frequency. The registry also lists hospital length of stay and chest tube removal as secondary outcomes without reporting their results. The posted adverse-event entries give counts for serious adverse events, other adverse events, and deaths, but these are separate from the primary malfunction endpoint.

The record also does not provide a comparator or describe a randomized comparison. Consequently, it cannot support a comparative conclusion about the AEON Endostapler versus another device or surgical approach. The study’s stated aim to test safety and efficacy is not itself evidence that either was established. Completion status does not substitute for outcome reporting, and the listed enrollment does not show how many participants were included in any endpoint analysis.

In general, results are most informative when an endpoint definition, analysis population, denominator, estimate, and measure of uncertainty are reported together. Those elements allow readers to distinguish the observed data from uncertainty about the underlying quantity. For this record, the primary result and its precision are not reported. The appropriate conclusion is limited to the study’s registered purpose, intervention, endpoint definition, and posted adverse-event counts; broader claims about device performance or comparative benefit are not supported by the registry record.

14. Why This Trial Matters Statistically

This study raises a statistically important distinction between registering an endpoint and reporting its result. A clear endpoint definition is useful: the primary measure identifies a participant-level product malfunction during surgery, with a specified timeframe and an operational description of what counts as malfunction. But a definition alone does not tell readers how often the event occurred. Without the result, analysis denominator, and uncertainty estimate, readers cannot assess the observed frequency or how precisely it was measured.

The record also illustrates why outcomes should not be conflated. Product malfunction, serious adverse events, other adverse events, deaths, hospital length of stay, and chest tube removal refer to different measures. A zero count in a listed adverse-event category cannot stand in for an unreported malfunction count or unreported secondary outcome. Keeping these categories separate is essential to avoid drawing a conclusion from a statistic that addresses a different question.

Study design also determines what a result can establish. The record lists an AEON Endostapler group and no comparator, and it does not describe randomized allocation. Even if a primary count were available, it would describe observed use in the listed group rather than provide a direct comparative estimate against another approach. Any general interpretation of a single-group event count must also consider the population, outcome ascertainment, follow-up, and analysis denominator.

Finally, statistical planning and observed evidence are not interchangeable. A sample-size illustration describes what might be required under specified assumptions; it does not show that an effect was observed or that a study achieved a particular power. The record’s 0 analyses and lack of a reported endpoint result make that distinction especially relevant. Transparent reporting of results and analysis methods is needed before readers can evaluate the precision or comparative meaning of the study’s findings.

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.

Several limitations are specific to the available registry record. It does not report the primary endpoint result, although the endpoint is defined as the number of participants with product malfunction during surgery, within surgery up to 8 hours. It also does not give the primary endpoint denominator, analysis population, or confidence interval. Without these, the observed frequency and precision cannot be assessed.

The record does not describe a comparator group or randomized allocation. Allocation is not stated, and the record does not present a like-for-like control comparison. This limits the kinds of comparative conclusions the study could support from the information posted. The record also does not report participant characteristics, eligibility details, enrollment flow, or whether the listed enrollment corresponds to the participants assessed for each endpoint.

Hospital length of stay and chest tube removal are listed as secondary outcomes, but their results are not reported in the registry record. The record lists 5 outcome measures and 0 analyses, without a statistical analysis plan, multiplicity approach, or explanation of how secondary outcomes were handled. Missing-data methods, follow-up completeness, and event ascertainment procedures are also not reported. These details would be relevant when interpreting both event counts and estimates of uncertainty.

The adverse-event entries list 0 affected for serious adverse events and 0 affected for other adverse events, with 0 deaths. The record does not give additional detail about event definitions, observation periods for these categories, or how the at-risk groups were determined. These entries therefore provide limited context and do not replace the missing primary endpoint result. The study’s own sample-size justification and any interim analyses are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Use of a New Stapling Device in General Thoracic Surgery — NCT05143541.
• Registry record last updated 2022-12-29; status last verified 2021-11.
• Results first posted 2022-01-21.
• 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

NCT05143541 is a completed study titled “Use of a New Stapling Device in General Thoracic Surgery.” The sponsor is Lexington Medical Inc. The registry lists thoracic cancer as a condition, enrollment of 80, a start date of 2021-03-01, and a primary completion date of 2021-09-30. The intervention is the AEON Endostapler, described as being used for stapling during surgery.

The primary endpoint is the number of participants with product malfunction during surgery, within surgery up to 8 hours. The registry defines malfunction as an occurrence during surgery in which the stapler does not perform as intended. Hospital length of stay and chest tube removal are listed as secondary outcomes. The primary and secondary outcome results are not reported in the registry record.

The adverse-event entries list 80 at risk and 0 affected for serious adverse events; 80 at risk and 0 affected for other adverse events; and 0 deaths. The record lists 0 analyses and does not describe a comparator, randomized allocation, analysis populations, missing-data procedures, or a statistical analysis plan. These limitations mean that the posted record describes the study’s purpose and measures but does not provide a reported primary endpoint estimate or comparative analysis.