A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System (NCT05665335), a na na study. The primary outcome is Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180..

2. Clinical Question

This is a question about a photographic assessment of change within a treated group. It is not a randomized comparison of treatment against another procedure or against no treatment. Consequently, the study design can describe the reviewers’ assessment of the treated participants, but the registry record does not establish how that assessment would compare with outcomes under an alternative approach.

The study also lists an independent photographic review comparing images at D90 with baseline as a secondary outcome. That earlier assessment is distinct from the primary assessment at 180 days. The record does not report results for either photographic review in the information available for this analysis. It also does not specify a more detailed clinical definition of improvement or report how reviewer judgments were converted into participant counts.

3. Trial Design

NCT05665335 is a prospective, non-randomized, single-center study in Greece, listed as completed. The registry describes treatment with the Renuvion APR System to both breasts in a single group. Enrollment is listed as 15, and the study summary describes treatment of up to 15 subjects. The phase is recorded as NA; allocation is also recorded as NA. Masking is recorded as NONE, although the brief summary describes an evaluator-blinded study and the primary outcome description refers to masked assessment by blinded independent reviewers. The registry does not explain how those masking descriptions relate to one another.

The recorded study start is 2022-11-28, and primary completion is recorded as 2024-04-26. These dates describe the study record; they do not indicate when each participant was treated or assessed. Individual participant timelines are not reported in the registry record.

Because there is one treatment group and no randomized comparator, the design is not a like-for-like controlled comparison. The primary question concerns a change from baseline in photographs reviewed after treatment. Baseline photographs are a reference point for assessment, not a separate control group. The record describes a prospective study, but does not report further protocol details about recruitment, eligibility criteria, treatment delivery, or follow-up procedures.

Apyx Medical is listed as the sponsor. The registry lists 18 outcome measures overall, while the outcome descriptions relevant to this analysis identify the 180-day primary photographic review and a D90 secondary photographic review. The registry record does not report a statistical analysis entry for the primary outcome. Study completion status alone does not establish that all outcome results have been reported.

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 Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180., measured over 180-Day.

The primary endpoint is the count of participants whose breast ptosis is judged to have improved from baseline, based on photographs assessed at 180 days after treatment. The registry describes the assessment as qualitative, performed by blinded independent reviewers, and compares post-treatment photographs with baseline photographs. The unit is participants, rather than breasts or photographs.

A photographic endpoint can provide a standardized way to assess visible change using images taken at different times. Independent review may reduce the influence of the treating team’s expectations, and masking is intended to limit reviewers’ awareness of information that could affect their judgment. These are general reasons for using such an approach; the registry record does not detail the review process, the number of reviewers, how disagreements were resolved, or the criteria used to classify improvement.

The endpoint description does not provide the observed count of participants judged to have improved, its denominator for the primary assessment, or an estimate of uncertainty. Those results are not reported in the registry record. The endpoint therefore defines what the study intended to assess, but the description alone cannot indicate the frequency of improvement or the precision of an estimate. The D90 photographic review is listed as secondary and should not be confused with the primary assessment at 180 days.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is expressed as a count of participants, with the event defined in the endpoint description as reviewer-assessed improvement in breast ptosis. In general, a count of participants with an event is interpreted alongside the number assessed. That denominator matters because participants without an available assessment cannot automatically be treated as either having or not having the event. The registry record does not report the primary outcome count, the number assessed at 180 days, or the handling of missing photographs.

In general, a proportion describes the share of assessed participants meeting a defined outcome. An estimate based on a small group can be imprecise, so an uncertainty interval is useful alongside the estimate. A confidence interval expresses a range of values compatible with the observed data under the method’s assumptions; it is not a guarantee that the true value lies in that range. No primary outcome estimate or confidence interval is reported in the registry record, so neither the observed event frequency nor its precision can be evaluated.

For a binary outcome, methods typically depend on how the outcome is classified and on the number of participants with complete assessments. The registry’s qualitative endpoint description does not state the operational threshold for improvement or how ambiguous reviewer judgments were handled. It also does not say whether reviewers assessed images independently before reaching a final classification. Those details affect reproducibility and interpretation, and are not reported in the registry record.

Baseline-to-follow-up assessment is different from a controlled treatment comparison. In general, a within-group change can show that measurements or judgments differ over time, but it does not identify the cause of the change. A concurrent comparison group can help distinguish treatment effects from time-related change and other influences, while random allocation can reduce systematic differences between groups. This study is listed as single-group and non-randomized, so those comparison features are absent from the recorded design.

The record lists a planning illustration based on a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as fractions of the observed effect. It describes that illustration as planning rather than as the study’s own design. Such calculations are hypothetical planning tools, not observed power and not evidence of an outcome. The assumed two-arm allocation does not match this single-group study. The observed effect and resulting planning values are not reported in the registry record, so the illustration cannot be assessed as a basis for this study’s design.

In general, a p-value summarizes how incompatible data are with a specified statistical model and null hypothesis, conditional on the assumptions of the analysis. It does not measure the size or clinical importance of an effect, and it does not establish causation. The registry record lists no analyses for the outcome, and no p-value or test procedure is reported. There is therefore no reported hypothesis test to interpret for the primary endpoint.

Over-dispersion is relevant to outcomes where variability is greater than a model assumes, such as some count outcomes. In general, ignoring over-dispersion can make uncertainty estimates too narrow and tests too optimistic. The primary endpoint is recorded as a participant count for a binary event, not as a rate of repeated events. No over-dispersion assessment or model is described in the registry record; it would not be appropriate to assume such an analysis was used.

Masking and independent review concern measurement quality rather than the statistical model itself. In general, masking can reduce the chance that an assessor’s expectations influence classification. The endpoint description refers to masked qualitative assessment by blinded independent reviewers, but the registry’s masking field is NONE. Since the record does not clarify the roles involved or give review procedures, the extent to which assessment bias was limited is uncertain.

Finally, statistical interpretation depends on a clearly specified analysis population and rules for incomplete follow-up. The registry record does not report whether the primary assessment was intended for all enrolled participants, only those with evaluable photographs, or another defined population. It also does not describe missing-data methods, adjustment for baseline features, or an analysis plan. These omissions prevent a fuller appraisal of how the endpoint would have been estimated.

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("Renuvion APR System")
n      <- c(15)
events <- c(11)
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  Renuvion APR System  15  11  73.3  44.9  92.2  48.0  89.1  47.6  89.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 18 outcome measures, including the primary photographic assessment at 180 days and a secondary photographic assessment at D90. When a study evaluates multiple outcomes, general statistical practice distinguishes the main confirmatory question from additional or exploratory questions. If many outcomes are tested, the chance of at least one apparently unusual result can increase. Methods such as prespecifying a hierarchy or adjusting for multiple comparisons may address that issue, but the registry record does not report a multiplicity strategy or a hierarchy among the listed measures.

No outcome analysis is listed, and the primary result is not reported in the registry record. Thus, there is no reported set of outcome estimates or tests from which to evaluate multiplicity in practice. The mere presence of multiple registered measures does not establish that every measure was analyzed, nor does the absence of listed analyses establish what analyses may have been conducted outside the registry.

The record does not describe missing-data rules, the number of participants with photographs available at each assessment, or the analysis population for the primary endpoint. In general, missing outcome assessments can affect both the denominator and the interpretation of an estimated event frequency. Treating unavailable assessments as if they were observed outcomes would require justification; the record does not indicate that this was done.

The registry’s enrollment and at-risk counts do not resolve these questions about endpoint-specific completeness. The number contributing to the primary photographic result is not reported in the registry record. No imputation, sensitivity analysis, or other missing-data procedure is described.

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 records 15 participants at risk for serious adverse events and 0 affected. It separately records 15 at risk for other adverse events and 0 affected, with 0 deaths. These are counts in the Renuvion APR System group; the study has no separate control group for comparing safety outcomes.

A recorded count of 0 affected means that the registry’s listed outcome field reports no participants with that category. It does not establish that every possible adverse event was absent, or show how actively events were sought. The record does not provide the adverse-event definitions, collection period, severity grading rules, or detail about follow-up completeness. No top serious-event terms are listed.

Safety counts should be interpreted in light of the study’s size, follow-up, and reporting practices. In general, an event not recorded in a study cannot be ruled out solely from a zero count, and a single-group count cannot show whether risk differs from another treatment or from no treatment. The registry provides no comparative safety analysis or uncertainty estimate. Accordingly, the reported counts describe the registry entries, rather than proving the absence of harm or establishing comparative safety.

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

The registry record establishes that a prospective, single-center, non-randomized study of the Renuvion APR System was completed, with an intended photographic assessment of breast ptosis at 180 days. The primary outcome was defined as a participant count based on qualitative review of photographs compared with baseline. The record also identifies a D90 photographic review as a secondary outcome. These details explain the question the study was designed to address.

The primary result itself is not reported in the registry record. There is no recorded count of participants judged to have improved, no reported denominator for the primary assessment, and no uncertainty interval or analysis result. The study description therefore cannot support a statement about the observed frequency or size of improvement. Its completion status does not fill in those missing results.

Even if a before-and-after result were available, the single-group design would limit causal interpretation. In general, change from baseline may be affected by factors other than the intervention, and a concurrent randomized comparator helps address that concern. No such comparator is described. The record also leaves the masking descriptions unreconciled: it records masking as NONE while describing evaluator blinding and blinded reviewers. The practical protection against biased assessment is consequently unclear.

The safety entries report 0 participants affected in the serious and other adverse-event categories, and 0 deaths, among the respective groups recorded as at risk. These are registry counts, not a comparative safety estimate. Without event definitions and collection details, they do not establish that all harms were absent.

In short, the record documents the design, intended endpoint, and limited safety counts, but not the primary outcome result. It cannot establish a treatment effect, rule out alternative explanations for change, or support comparison with another procedure. Those conclusions would require outcome reporting and, for comparative causal claims, evidence from an appropriate comparison design.

14. Why This Trial Matters Statistically

This study is statistically notable because its main question relies on before-and-after photographic assessment in a single treated group. That makes the distinction between an outcome definition and an outcome result especially important. The registry describes what reviewers were asked to assess, but does not report the resulting participant count. Without that result, neither the apparent frequency of improvement nor its uncertainty can be judged.

The design also illustrates why a baseline reference is not equivalent to a control group. In general, a baseline comparison can document change, while a randomized concurrent group can help estimate whether change differs from what might occur without the intervention. The registry lists no such comparison and identifies the study as non-randomized and single-group. Therefore, even a reported change would need to be interpreted within those design limits.

Photographic assessment places emphasis on measurement procedures. Blinded independent review may reduce some forms of assessor influence, but the record’s masking field says NONE while its narrative describes evaluator blinding and blinded reviewers. A clear account of who was masked, the image-review protocol, and how judgments were combined would help readers assess measurement reliability. Those details are not reported in the registry record.

Finally, the registry lists multiple outcome measures but no outcome analyses. This makes transparency about outcome reporting, missing assessments, and multiplicity important. The safety counts are also best read as recorded counts rather than as comparative evidence. Together, these features make the record useful for understanding the intended evaluation and its limits, while leaving the central result unavailable for statistical interpretation.

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 primary limitation for interpreting this record is that the primary outcome result is not reported. The registry specifies an endpoint but gives no observed participant count judged to have improved, no endpoint-specific denominator, and no uncertainty estimate. Results for the D90 secondary photographic assessment are also not reported in the registry record.

The design is single-group and non-randomized, with no concurrent control group described. A baseline photograph provides a reference for assessment but cannot by itself distinguish intervention-associated change from other influences. The record does not report details about participant eligibility, recruitment, or the characteristics of those enrolled, which also limits assessment of how broadly findings might apply.

Important measurement details are absent. The record does not describe the threshold for qualitative improvement, the image acquisition protocol, the number of independent reviewers, disagreement resolution, or reliability assessment. It gives differing masking descriptions—NONE in the masking field and evaluator-blinded or blinded independent review in the narrative—without explaining how they fit together.

The analysis population, missing-data handling, and statistical analysis plan are not reported in the registry record. Although 18 outcome measures are listed, no analyses are listed, and no multiplicity approach is described. The safety information is limited to recorded at-risk and affected counts; adverse-event definitions, collection procedures, and detailed follow-up are not reported. These gaps prevent evaluation of the completeness and precision of efficacy and safety findings.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System — NCT05665335.
• Registry record last updated 2025-05-14; status last verified 2025-04.
• Results first posted 2025-05-14.
• 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

NCT05665335 is a completed, prospective, non-randomized, single-center study in Greece sponsored by Apyx Medical. It evaluated treatment of both breasts with the Renuvion APR System in a group with an enrollment listed as 15. The primary endpoint was a qualitative independent photographic assessment of improvement in breast ptosis at 180 days compared with baseline. A D90 photographic review was listed as a secondary outcome.

The record lists 18 outcome measures and 0 analyses. It reports 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths, with 15 at risk in each adverse-event category. The primary efficacy result and details about endpoint completeness, missing data, and analysis methods are not reported in the registry record. Masking is recorded as NONE, while narrative descriptions refer to evaluator blinding and blinded independent reviewers.