Safety and Performance of ENTACT Septal Staple System for Septoplasty: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Performance of ENTACT Septal Staple System for Septoplasty (NCT04392583), a registered phase not stated study. The primary outcome is Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit.

2. Clinical Question

3. Trial Design

This was a prospective, multi-center, single-arm post-market clinical follow-up study of the ENTACT Septal Staple system for septoplasty. The registry record lists an enrollment of 40 and a completed study status. The study started on 2020-10-22, and primary completion was 2021-06-02. The stated purpose was to evaluate safety and performance and provide evidence for PMCF requirements associated with CE Marking in Europe; the record notes that data might also support registrations in other countries.

With a single arm, the study can describe outcomes among participants treated with the device, but it does not directly estimate a difference from a concurrent control group. The registry record specifically identifies the study as not being a randomized comparison. A control group, random assignment, and a comparative treatment effect are not reported in the registry record.

The primary endpoint was assessed at the 21-day follow-up visit. It combined clinician judgments about five features of the nasal cavity and surgery site. Clinical success required YES responses to every criterion; any NO response was classified as repair failure. The record also lists secondary assessments at 5, 21, and 42 days for septum appearance, flap coaptation, local tissue reaction, hematoma swelling, and need for re-intervention. Other listed measures include NOSE scores, VAS pain scores, and total operation time, including by surgery-procedure combinations.

The registry record does not report a detailed statistical analysis plan, recruitment flow, participant characteristics, or numerical results for the primary endpoint. It also does not describe how many participants contributed data at each assessment. Those gaps limit assessment of the study's conduct and the precision of its performance findings.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.

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: All participants enrolled in the study (i.e., received the study device).

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit, measured over 21 days.

The primary endpoint is the percentage of participants judged to have clinical success at the 21-day follow-up visit. A clinician examined the nasal cavity and recorded YES or NO for straight septum-wall appearance, complete coaptation of the perichondrial flaps, absence of significant local tissue reaction at the staple site, absence of hematoma swelling at the staple site, and no need for re-intervention at the surgery site. Success required YES on every item. A NO on any item was defined as repair failure.

This all-criteria definition makes the endpoint a composite: it combines several distinct clinical observations into a single participant-level classification. That can be useful when the intended assessment is whether a set of desired findings is present together, rather than whether an individual feature is present in isolation. At the same time, the overall percentage does not show which criterion was most often unmet. The registry record lists related component assessments as secondary outcomes at 5, 21, and 42 days.

The endpoint is reported as a percentage with a 95% confidence interval specified as its dispersion measure. A confidence interval describes statistical uncertainty around an estimate; it does not by itself account for all possible sources of bias or measurement variation. The registry record does not report the observed primary percentage or confidence interval, so the endpoint's estimated level and precision cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary percentage represent?

General: A percentage for a binary outcome represents the share of an analysis population classified in the outcome category of interest. Here, the category is clinical success under the registry's all-criteria rule. A participant counts as a success only when each listed clinical observation is YES; any NO response is defined as repair failure. The endpoint is therefore not a score that averages the five observations. It is a combined classification based on whether the complete set of conditions is met.

The denominator matters. The primary endpoint description identifies the Full Analysis Set as enrolled participants with at least one post-baseline visit and available data at the specified timeframe. The registry record does not state the number with evaluable data for the 21-day assessment or give the observed count classified as clinical success. Without those values, the percentage cannot be independently checked or interpreted.

How should a confidence interval be read?

General: A confidence interval expresses uncertainty around an estimate under the statistical method used to calculate it. A narrower interval indicates greater statistical precision under that method; a wider interval indicates less precision. It does not describe the range of individual participant outcomes, and it cannot remove uncertainty due to study design, outcome measurement, missing observations, or selection into an analysis population. The primary endpoint names a 95% confidence interval, but the interval itself is not reported in the registry record.

The record does not identify the specific method used to calculate the confidence interval. Different methods can behave differently, particularly when event counts or sample sizes are limited. The method, estimate, and denominator would all be needed to assess the interval's construction and meaning in this study.

What can a single-arm study estimate?

General: A single-arm study can describe outcomes observed among participants receiving the study intervention. It lacks a concurrent comparator for estimating a between-group contrast. Thus, even a precisely estimated percentage would be a description of the study group under the recorded conditions, not an estimate of a treatment difference. The registry record identifies this study as single arm and not randomized; comparative effect estimates are not reported.

The prospective and multi-center descriptors concern the study's forward-looking collection and setting across centers. They do not, by themselves, supply a control group or specify methods for handling differences among centers. The registry record does not report center-specific results or an adjustment for center.

How do repeated visits and secondary outcomes affect interpretation?

The record lists assessments at 5, 21, and 42 days for several clinical features, alongside NOSE and VAS scores collected before surgery and at post-operative visits. General: Repeated observations can describe how outcomes vary over follow-up, but interpreting change requires knowing the measurement schedule, available data, analysis method, and handling of missing visits. The posted results do not include numerical values for these measures or a statistical plan for repeated measurements.

The registry also lists total operation time overall and by surgery-procedure combinations. The meaning of these summaries would depend on how operation time was defined and which procedures were included; those details are not reported in the registry record. No values or comparative analyses for operation time are reported.

What do the planning assumptions mean?

The record describes a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Those are assumptions for a planning calculation, not a description of the trial's single-arm design or an observed outcome. Sample-size illustrations are planning aids, not observed power. The registry record does not report the values of the illustration or the observed effect on which it is based, and it does not report the trial's own sample-size justification.

In general, a planning calculation depends on its assumed effect, variability or event rate, significance level, power target, allocation, and chosen method. Changing assumptions can change the resulting planning estimate. Since the numerical illustration and its underlying effect are not reported in the registry record, it cannot be evaluated as evidence about the trial's observed precision or findings.

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("Device: ENTACT Septal Staple")
n      <- c(38)
events <- c(36)
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  Device: ENTACT Septal Staple  38  36  94.7  82.3  99.4  82.7  98.5  82.7  98.4

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 10 outcome measures, including the primary composite endpoint, component clinical assessments at 5, 21, and 42 days, NOSE scores, VAS pain scores, and operation time. It reports 0 analyses. A statistical plan for controlling multiplicity, selecting among outcomes, or interpreting multiple time points is not reported in the registry record.

General: When a study examines multiple outcomes or time points, the chance of finding an apparently notable result somewhere among them can differ from the chance associated with a single prespecified test. Multiplicity methods can address that issue, but the appropriate approach depends on the study aims and analysis plan. No adjustment method, testing hierarchy, or distinction between confirmatory and exploratory analyses is reported. Because no numerical outcome analyses are posted, there are no reported p-values or analysis results whose multiplicity handling can be assessed.

The primary endpoint population is described as the Full Analysis Set: enrolled participants with at least one post-baseline visit and available data at the specified timeframe. The record does not report the number included in that set for the primary assessment, the number with missing endpoint data, reasons for missingness, or an imputation or sensitivity-analysis approach. Missing-data handling is therefore not reported in the registry record.

These omissions matter because an endpoint percentage depends on which participants have evaluable observations and how unavailable observations are treated. The record's population definition gives a rule for inclusion but not the actual flow of participants through the analysis. It is not possible to establish from the posted results whether missing observations affected the estimate.

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.

Most frequent non-serious adverse event terms

The registry record lists the ENTACT Septal Staple group with 40 participants at risk for serious adverse events and 0 affected, 40 at risk for other adverse events and 4 affected, and 0 deaths. These are reported counts; no rates or additional calculations are needed to read them. The record does not list serious adverse-event terms.

Serious adverse events and other adverse events are separate categories in the record. The serious-event count should not be conflated with the count of participants affected by other adverse events. The registry does not provide event descriptions, timing, severity details for the other adverse events, or an assessment of whether events were related to the device. Such details are not reported in the registry record.

General: Adverse-event counts describe observations collected under the study's reporting approach. In a single-arm study, they do not establish a causal comparison with another treatment or background risk. The observed counts also do not, by themselves, describe the likelihood of uncommon harms beyond the study's observed participants and follow-up. The record's reported counts should therefore be read as a limited safety description, not as a comparative safety estimate.

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

The registry record documents a completed, prospective, multi-center, single-arm PMCF study of the ENTACT Septal Staple system for septoplasty, with enrollment of 40. It defines clinical success at the 21-day visit using a stringent composite rule: every listed nasal-cavity and surgery-site criterion must be judged YES. That definition makes the intended outcome clear, but an endpoint definition is not an outcome result.

The numerical primary result and its 95% confidence interval are not reported in the registry record. As a result, the posted information does not establish the observed proportion meeting the composite definition or the precision of that estimate. The record also does not report numeric results for the component clinical assessments, NOSE scores, VAS pain scores, or operation time. It is not possible to identify from the posted results which clinical features were met or how those measures changed over follow-up.

The single-arm design means there is no concurrent control group for estimating a treatment contrast. The record identifies the study as not randomized and does not report a comparative analysis. Even if descriptive outcomes were available, they would not by themselves establish how those outcomes compare with another procedure or device.

Safety reporting includes 0 participants affected by serious adverse events, 4 affected by other adverse events, and 0 deaths in the ENTACT group. These counts do not establish causation, and event descriptions or attribution are not reported in the registry record. Overall, the record supports understanding the study's design, endpoint definition, and limited safety counts, but not a quantified conclusion about the primary endpoint's observed performance or a comparative treatment effect.

14. Why This Trial Matters Statistically

This trial illustrates the distinction between a clearly defined endpoint and a reported endpoint result. The primary measure specifies a 21-day clinical-success classification based on several observable features. That definition is essential for knowing what the intended percentage means. Yet without the observed percentage, denominator, and confidence interval, readers cannot assess the estimate's magnitude or precision.

The composite rule also raises a useful statistical and clinical interpretation issue. Combining criteria into an all-or-none endpoint captures whether all specified conditions were met together. But a single composite percentage can conceal variation among its components: a participant classified as a failure could have one unmet criterion or several. Component results would help explain the composite, but they are not reported in the registry record.

The single-arm design makes careful wording particularly important. Descriptive findings, if reported, would characterize outcomes in the study group. They would not provide a randomized comparison or isolate a treatment effect against a concurrent control. The record explicitly identifies the study as not randomized and does not report comparative results.

Finally, the study's post-market follow-up purpose and its listed safety counts are distinct from evidence about comparative effectiveness. The record lists 0 serious adverse events affecting participants, 4 affected by other adverse events, and 0 deaths, but does not provide event terms or attribution. A transparent account of outcome estimates, uncertainty, missing data, and analysis methods would be needed to support a fuller statistical assessment. The posted record leaves those elements unreported, making the limits of what can be concluded as important as the endpoint's definition.

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 direct limitation for statistical interpretation is that the registry record does not report the primary endpoint estimate or its 95% confidence interval. Although the outcome is defined, its observed frequency and precision cannot be assessed. The record lists 0 analyses, and numerical results for the listed secondary measures are also not reported in the registry record.

The study is single arm and not randomized, with no comparator described. This limits the design's ability to estimate a comparative effect. The registry record does not report participant characteristics, center-specific data, or details that would allow readers to assess how representative the enrolled participants were or whether outcomes varied by center.

The Full Analysis Set definition requires at least one post-baseline visit and available data at the relevant timeframe, but the record does not state how many participants had evaluable primary endpoint data. Reasons for missing visits or observations, methods for handling missing data, and sensitivity analyses are not reported in the registry record. The effect of missing information on any estimate therefore cannot be evaluated.

The primary endpoint is a composite based on five clinical judgments. The registry record does not report component results, assessment procedures beyond the stated clinician examination, or information about consistency of outcome assessment. The statistical analysis plan, confidence-interval method, multiplicity approach, and trial-specific sample-size justification are also not reported in the registry record. The planning assumptions described in the record do not fill those gaps or establish observed precision.

Safety reporting is limited to counts of participants affected and does not include serious-event terms, descriptions of other events, or causal attribution. These limitations constrain interpretation of both performance and safety based on the posted record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Safety and Performance of ENTACT Septal Staple System for Septoplasty — NCT04392583.
• Registry record last updated 2022-06-15; status last verified 2022-05.
• Results first posted 2022-05-18.
• 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

The registry record describes NCT04392583, a completed, prospective, multi-center, single-arm post-market study of the ENTACT (Next Generation) resorbable septal staple system for septoplasty. Enrollment was 40. The study started on 2020-10-22, with primary completion on 2021-06-02. Its stated purpose was to evaluate safety and performance and support PMCF requirements for CE Marking in Europe.

The primary endpoint was the percentage of participants meeting all clinical-success criteria at the 21-day follow-up visit, with a 95% confidence interval specified. The numerical primary result and confidence interval are not reported in the registry record. The record lists 10 outcome measures and 0 analyses. It reports 0 participants affected by serious adverse events, 4 affected by other adverse events, and 0 deaths in the ENTACT group.

The study has no comparator and is not a randomized comparison. Participant characteristics, detailed analysis methods, missing-data handling, and numerical secondary outcome results are not reported in the registry record.