Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction (NCT04012814), a na na study. The primary outcome is Change in Aesthetic Appearance From Baseline.

2. Clinical Question

The clinical question is therefore about the photographic appearance of the abdomen and flanks after the treatment schedule, as judged against baseline images. The study also lists subject satisfaction and change in fat thickness as secondary outcomes, but their results are not reported in the registry record.

Because the design has no separate control group, the endpoint addresses change relative to baseline rather than a treatment effect relative to an untreated or alternative-treatment group. Changes observed over time can be described, but this design alone does not separate treatment-related change from other influences that may affect appearance or assessment. The registered information also does not describe the participants’ baseline characteristics, so the range of people to whom any result might apply cannot be assessed from this record.

3. Trial Design

The registry describes a completed, open-label, baseline-controlled, multi-center study of Venus Bliss for non-invasive fat reduction of the abdomen and flanks. Its model is single-group, and allocation is listed as NA. The record does not describe a randomized comparison or a separate control arm. The design information therefore supports an assessment of change from baseline, not a controlled estimate of the difference between treatment and a comparator.

The treatment group received 3 diode treatments and 3 RF/PEMF treatments, scheduled at Week 0, 8 and 16. Follow-up was scheduled at Week 24. The primary endpoint uses photographs from Week 0 and Week 24, with an independent, blinded reviewer assessing the images. Thus, although the study is open-label, the primary photographic evaluation is described as blinded. The registry does not report further details about the reviewer process, image handling, or whether other assessments were blinded.

The registry lists enrollment as 39 and status as COMPLETED. The study start date is 2019-09-19, and the primary completion date is 2022-10-22. Those registry entries do not establish how many participants completed follow-up, had usable paired photographs, or were included in an analysis. The primary endpoint population is defined as all subjects with both Week 0 baseline and Week 24 follow-up photos, but the count in that population is not reported in the registry record.

The record identifies three outcome measures, including the primary aesthetic-appearance measure and secondary measures of subject satisfaction on a 5-Point Likert Subject Satisfaction Scale and change in fat thickness. It records no analyses. Protocol details such as eligibility criteria, site count, the planned statistical analysis, and the handling of withdrawals are not reported in the registry record. The single-group structure and absence of reported results limit what can be concluded about efficacy, regardless of the study’s completed status.

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: All subjects who had both Week 0 (baseline) and Week 24 (follow-up) photos.

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 Change in Aesthetic Appearance From Baseline, measured over Week 24.

The primary endpoint is titled “Change in Aesthetic Appearance From Baseline.” It is assessed at Week 24 by an independent, blinded reviewer comparing pre-treatment baseline images with post-treatment images. The score is described as a score on a scale and is summarized as a mean with standard error. The endpoint population consists of subjects who had both Week 0 baseline and Week 24 follow-up photographs.

The scale assigns 0 to no change. A score of 1 indicates slight change, 2 moderate change, and 3 dramatic change. When the reviewer incorrectly identifies which images are pre-treatment baseline images, the description assigns negative scores: -1 for slight, -2 for moderate, and -3 for dramatic change. This scoring approach incorporates the reviewer’s ability to distinguish baseline from follow-up images as well as the judged magnitude and direction of change.

Photographic assessment offers a structured way to evaluate visible appearance using a defined scale. Blinding the reviewer is intended to reduce the influence of knowledge about treatment status on image assessment. The registry does not report the mean score, its standard error, the number of evaluable image pairs, or further details on how images were presented and scored. Consequently, the endpoint’s definition can be described, but the magnitude and precision of the observed result cannot be evaluated from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean score describe?

General statistical explanation: A mean is an average across the observations included in an analysis. For this endpoint, the intended observations are photographic assessment scores from subjects with both baseline and Week 24 images. A mean score would give a compact description of the group’s average assessment, but it would not show how scores varied among participants. A mean can also conceal a mixture of different individual responses. The registry identifies the endpoint as a mean measure but does not report the numerical mean or the underlying distribution.

The scale has meaningful ordered categories, ranging from negative scores for incorrectly identified images to positive scores for degrees of change, with 0 representing no change. Treating a score as a mean provides a summary, but the interpretation depends on the scoring system and how its categories relate to one another. The registry does not report analyses of individual score categories or further information about the distribution. No category-level pattern can therefore be described.

What does the standard error tell the reader?

General statistical explanation: A standard error describes the precision of an estimated mean. It is not the same as the spread of individual scores: the spread describes how observations differ from one another, while the standard error concerns uncertainty in the estimate of the group mean. A smaller standard error generally indicates a more precise estimate, given the assumptions of the analysis. The registry states that the primary measure is reported with a standard error, but it does not give the standard error value. The precision of the primary result cannot therefore be assessed.

A confidence interval is a range calculated by a statistical procedure to express uncertainty around an estimate. Its interpretation depends on the method and assumptions used. The registry record does not report a confidence interval for the primary endpoint or the statistical procedure used to construct one. It would not be appropriate to infer an interval from the endpoint description alone.

Why does blinding matter for a photographic rating?

General statistical explanation: Blinding an assessor can reduce the chance that expectations or knowledge of treatment status influence a subjective rating. The primary endpoint description states that an independent, blinded reviewer evaluated the photographs. This feature may reduce one source of assessment bias, but it does not remove every potential source of bias. It does not, by itself, control for changes over time, ensure that image pairs are comparable, or establish a causal treatment effect. Details about the reviewer process and image presentation are not reported in the registry record.

The study is otherwise listed as open-label and single-group. These design characteristics matter because participants and study personnel may know that treatment was given, and there is no registered comparison group to show what might have happened without the intervention or under another intervention. The registry calls the study baseline-controlled, which refers to the baseline comparison; it should not be mistaken for a randomized control group.

How should planning estimates be distinguished from results?

General statistical explanation: A sample-size calculation asks how much information a future study might need under chosen assumptions. It does not demonstrate that an observed effect is real, and a planning estimate is not a result from the completed study. The planning illustration associated with this record is explicitly based on an observed effect rather than the trial’s own design. Its assumptions specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect set as a stated proportion of the observed effect.

Those assumptions describe a hypothetical planning framework, not the registered single-group treatment schedule. The registry record does not provide the observed effect used in the illustration or the numerical planning outputs. The illustration should not be interpreted as observed power, as a formal justification for the enrollment field, or as evidence that the trial’s design could detect a specified effect. The sample-size justification and statistical plan for the trial itself are not reported in the registry record.

Why do over-dispersion and model choice sometimes matter?

General statistical explanation: In analyses of counts, over-dispersion means that observed variability is greater than a chosen model expects. When present, it can make standard errors too small if the model does not account for the extra variability. The primary endpoint in this study is a continuous score summarized by a mean and standard error, and the registry does not report a count model or any model-based analysis. There is no basis in the record to say whether over-dispersion was assessed or whether it applies to any analysis.

More generally, statistical interpretation depends on the outcome definition, analysis population, missing-data handling, and analysis method. For this trial, the primary population is defined by having both baseline and follow-up photographs, but the number included and the method for handling unavailable images are not reported. No analysis model, adjustment strategy, confidence interval, or hypothesis test is reported in the registry record. The absence of those details does not establish that no analysis was conducted outside the record; it means the posted record does not document one.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Subject Treatment Group")
n   <- c(31)
m   <- c(0.97)
sp  <- c(0.08)
sd  <- sp * sqrt(n)      # standard errors converted to SDs
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Subject Treatment Group  31  0.970  0.445  0.807  1.133

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and two secondary outcomes: subject satisfaction on a 5-Point Likert Subject Satisfaction Scale and change in fat thickness. Testing or interpreting multiple outcomes can raise multiplicity concerns, because considering multiple results may increase the chance of highlighting an apparently notable finding by chance. How that concern should be handled depends on the prespecified analysis plan and the intended interpretation of each outcome.

The registry record does not report a multiplicity strategy, such as a hierarchy among outcomes or an adjustment to account for multiple tests. It also records no analyses and does not provide results for the primary or secondary outcomes. No conclusion about statistical significance across these measures can be made from the record.

The primary endpoint population is subjects with both Week 0 baseline and Week 24 follow-up photos. The number meeting that definition is not reported in the registry record. The record does not explain whether participants without paired photographs were excluded, how missing images were handled, or whether any alternative analysis population was used. Enrollment of 39 should not be assumed to equal the number included in the primary endpoint analysis.

Details on intention-to-treat or per-protocol populations, imputation, sensitivity analyses, protocol deviations, and missing-data assumptions are not reported in the registry record. These omissions limit assessment of how robust an outcome estimate might be to incomplete follow-up. Since the numerical endpoint results are also absent, neither the impact of missing data nor the role of multiplicity can be evaluated for this study.

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 reports safety counts for the Subject Treatment Group. For serious adverse events, 39 participants are listed as at risk and 0 as affected. For other adverse events, 39 are listed as at risk and 8 as affected. Deaths are listed as 0. These are the counts in the registry record; they do not establish how events were defined, collected, or attributed.

The record does not list serious adverse-event terms, and the top serious terms list is empty. It also does not give descriptions of the other adverse events, their timing, severity, duration, or relationship to treatment. The meaning of the registry’s “other” category is not further explained in the record. The counts should therefore not be expanded into claims about specific symptoms or event types.

These figures are descriptive and come from a single-group study. There is no separate safety comparator in the registered design, so the counts cannot show whether event occurrence differed from another treatment or from no treatment. The registry’s enrollment field is 39, but the safety figures should be interpreted as the reported at-risk counts rather than as a basis for assuming the completeness of all follow-up or event ascertainment.

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

The registry record establishes that a completed, open-label, single-group study evaluated Venus Bliss for non-invasive fat reduction of the abdomen and flanks. It describes a treatment schedule and a Week 24 photographic endpoint assessed by an independent, blinded reviewer. It also reports safety counts and names secondary outcomes. These details explain what the study intended to assess and how its primary endpoint was defined.

The record does not report the primary mean score, standard error, confidence interval, or analysis results. It therefore does not show the direction or magnitude of the average photographic score, or how precisely that score was estimated. Although the endpoint scale defines categories of change, the scale definition is not evidence that any particular category or mean was observed. The registry also does not report results for subject satisfaction or change in fat thickness.

Even if a change from baseline were reported, a before-and-after result in a single-group study would not by itself isolate the effect of treatment. Without a separate control group, changes over time could reflect influences other than the intervention. Blinding of the photographic reviewer is a useful design feature for that assessment, but it does not replace a control comparison or address every source of uncertainty.

The reported serious and other adverse-event counts describe what is recorded in the registry, but lack event-level detail and a comparator. They do not establish the full safety profile. Overall, the available record supports a description of the design, endpoint, and reported counts, but it does not support a conclusion about the size, precision, or causal interpretation of a treatment effect.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the difference between an endpoint definition and an endpoint result. The registry gives a specific photographic scoring rule and identifies the assessment timepoint, but does not report the resulting estimate or its uncertainty. Without those values, readers cannot judge whether the average score indicated change, how large the change was, or how precisely it was estimated.

The design also highlights the distinction between baseline control and a concurrent control group. Comparing follow-up with baseline can describe change within the treated group. A separate control group would address a different question by providing a comparison for changes that might occur over time without the treatment or with an alternative. The registered design is single-group, so it does not offer that contrast.

The endpoint uses an independent, blinded reviewer, which is relevant when a judgment depends on photographs and a defined rating scale. Yet assessor blinding and randomized allocation address different potential sources of bias. The former may limit influence on scoring; it does not make the treatment comparison randomized or establish that observed change is attributable to treatment.

Finally, the endpoint population depends on paired baseline and follow-up photographs. The registry’s enrollment field alone does not disclose how many participants had those images, and missing-data handling is not documented. That distinction matters because the population contributing to an endpoint can affect how broadly its result applies. In this record, the absence of analysis results and analysis-population detail makes those considerations especially important.

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 principal limitation of the registry record is that it contains no reported analyses and no numerical result for the primary endpoint. The primary endpoint is described, but its mean and standard error are absent. The record also does not report confidence intervals or hypothesis tests. Thus, the statistical strength and precision of any observed change cannot be assessed from the registry.

The single-group, open-label design does not provide a concurrent comparator. Baseline photographs serve as the reference for the primary assessment, but a baseline comparison cannot distinguish treatment-associated change from other changes over time. The independent, blinded reviewer may limit bias in photographic scoring, while leaving the lack of a controlled comparison unresolved.

The primary analysis population is defined by availability of both Week 0 and Week 24 photographs, but its size is not reported. Missing-data handling, alternative analysis populations, protocol deviations, and sensitivity analyses are not described. The registry enrollment field of 39 does not show how many participants contributed to the endpoint.

The record does not report participant characteristics, detailed eligibility criteria, the statistical plan, multiplicity procedures, or the sample-size justification for the trial. It does not provide results for either listed secondary outcome. Safety reporting includes aggregate counts without event descriptions or detail on ascertainment. These limitations are specific to the information available in the registry record and restrict assessment of both efficacy and safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction — NCT04012814.
• Registry record last updated 2024-04-23; status last verified 2024-04.
• Results first posted 2024-04-23.
• 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

NCT04012814 is a completed, open-label, multi-center, single-group study of Venus Bliss for non-invasive fat reduction of the abdomen and flanks. The registry lists enrollment as 39 and describes 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16, with follow-up at Week 24.

The primary endpoint is a Week 24 photographic assessment of change from baseline by an independent, blinded reviewer. The registry defines the score and its mean-with-standard-error summary but does not report the numerical primary result or any analyses. Secondary outcomes are subject satisfaction and change in fat thickness; their results are not reported in the registry record.

Safety counts list 0 serious adverse events, 8 other adverse events, and 0 deaths. Event details are not reported. The single-group design permits description of change from baseline but does not provide a randomized comparator for attributing change to treatment.