CONtrolled Focal Fibrous Band Release Method Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for CONtrolled Focal Fibrous Band Release Method Study (NCT04743635), a non-randomized na study. The primary outcome is The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants.

2. Clinical Question

The study asked whether a single procedure using the Avéli device for Targeted Verifiable Subcision (TVS) was associated with a change in cellulite severity among participants treated on the thighs and buttocks. The primary question concerned the mean change in Cellulite Severity Scale (CSS) score from baseline to 3 months in the modified intent-to-treat population.

The study also listed outcomes concerning Global Aesthetic Improvement Scale (GAIS) improvement at 3 months and 12 months, CSS change at 12 months, and satisfaction at 3 months and 12 months. These outcomes describe additional assessments of appearance, severity, and participant satisfaction. Their numerical results are not reported in the registry record.

Because the study had one group and no randomized comparator, its before-and-after question is different from a comparison of treatment with an alternative or with no treatment. A change over time in the treated group can be described, but the design alone cannot separate any change associated with the procedure from other influences that may also affect measurements over time. The missing primary result also prevents a reader from determining the direction, magnitude, or precision of the reported endpoint from this record.

3. Trial Design

The registry identifies NCT04743635 as a completed, nonrandomized, single-group device study. It lists Revelle Aesthetics, Inc as the sponsor and cellulite as the condition. The study began on 2021-01-07, reached primary completion on 2021-06-14, and has a completed status. The phase is listed as not applicable.

The intervention was the Avéli device, used for a single TVS procedure. The registry record describes cellulite treatment on the thighs and buttocks. Allocation was nonrandomized, and masking was listed as none. These design details mean that the study did not assign participants at random to a treatment group and a control group. The registry record therefore does not support a like-for-like comparison between two arms.

Enrollment was 74. The effectiveness population was the modified intent-to-treat group of 68 participants. The remaining 6 participants were classified as roll-in participants and excluded from effectiveness analyses. The description says that, for investigators who had not previously performed an Avéli procedure, two participants were classified as roll-in participants. The registry does not provide further details about investigator-level enrollment or how the allocation to the two populations was implemented.

The primary outcome was the mean change in CSS score from baseline to 3 months in the modified intent-to-treat population. The scale was assessed by three independent, blinded physician assessors using images taken before and 3 months after treatment. This endpoint definition includes blinded assessment of images even though overall masking is listed as none; the record does not explain additional masking procedures or their implementation.

Six outcome measures and three analyses are recorded. The registry record does not report a statistical analysis plan, a sample-size justification, planned interim analyses, or details sufficient to reconstruct how the listed analyses were conducted. Numerical primary and secondary effectiveness results are not reported in the registry record.

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.

Before assignment: 74 was total enrollment: * 68 participants allocated to Targeted Verifiable Subcision (TVS) with the Avéli device, mITT * 6 participants allocated to Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-Ins. 6 training participants for 3 new Investigators.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: mITT

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 The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants, measured over 3 months.

The primary endpoint was the mean change from baseline to 3 months in CSS score among participants in the modified intent-to-treat population. CSS is a score on a scale with a stated range of 0-5. The registry describes its total score as the sum of Part A and Part B, minus 1. Part A categorizes the number of evident depressions, while Part B categorizes their average depth. Thus, the score combines two features of cellulite appearance rather than representing a direct count of lesions or a measurement in physical units.

The registry says that three independent, blinded physician assessors evaluated images taken before and 3 months after treatment. In general, a standardized scale can make assessments more consistent by giving assessors defined categories. Use of images and blinded assessment can also reduce some opportunities for knowledge of treatment status to influence scoring. The record does not describe how assessors' ratings were combined or whether agreement between assessors was evaluated.

A mean change summarizes the average within-participant difference between baseline and follow-up scores. It is useful for describing the direction and average size of change across the analysis population, but it does not show whether every participant changed in the same way. The registry gives the endpoint definition but not its observed mean change, standard deviation, confidence interval, or other numerical result. Those quantities are not reported in the registry record, so the magnitude and precision of the primary endpoint cannot be evaluated from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is a continuous score, and the registry identifies the target summary as a mean. In general, a mean is the arithmetic average of observed values. For a change endpoint, the relevant values are each participant's follow-up score relative to that participant's baseline score. The average then describes the central tendency of those changes in the analysis population. The record defines the endpoint as change from baseline to 3 months, but does not report the mean change itself.

What does the CSS score represent?

The CSS is described as a 6-point scale with a range of 0-5. The total score is defined as (PART A + PART B) - 1. Part A classifies the number of evident depressions, with categories from none through mild, moderate, and severe. Part B classifies the average depth of depressions, also from none through mild, moderate, and severe. The scale therefore combines categories describing number and depth. It is not a direct measure in millimeters, even though depth categories are defined using millimeter ranges.

In general, interpreting a mean on a bounded score requires attention to the scale's construction and limits. A numerical change summarizes average movement on the score, but the same average can arise from different distributions of individual changes. Some participants may have larger changes and others smaller changes, or changes may vary in direction. The mean alone does not reveal that pattern. The registry does not report a distribution of individual changes or additional summaries that would show how participant responses varied.

Why is the analysis population important?

The record identifies the modified intent-to-treat population as the population used to evaluate effectiveness and describes it as 68 participants. It separately identifies 6 roll-in participants, excluded from effectiveness analyses. In general, an analysis population determines which participants contribute to an estimate and can affect how broadly that estimate applies to those enrolled. The record does not provide a fuller operational definition of modified intent-to-treat, such as specific inclusion requirements based on receiving treatment or having follow-up measurements. That definition is not reported in the registry record.

Missing-data methods are also relevant to a change endpoint because a participant's change requires usable baseline and follow-up information. The registry record does not state whether there were missing CSS assessments, how missing values were treated, or whether any imputation or sensitivity analysis was used. It is therefore not possible to determine from the record whether the analysis used all 68 participants or a subset with available endpoint data. The described population size should not be mistaken for a confirmed number with complete primary-outcome measurements.

What would a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated mean under a statistical model and its assumptions. A narrower interval indicates greater precision under those assumptions, while a wider interval indicates less precision. It does not describe the range of individual participant outcomes. Neither a confidence interval nor a numerical mean change for the primary endpoint is reported in the registry record. As a result, neither the estimated average nor its precision can be assessed.

The registry identifies standard deviation as the dispersion measure for the primary outcome. In general, standard deviation describes the spread of participant values around their mean, and a larger standard deviation indicates more variability in those values. It is distinct from a confidence interval, which concerns uncertainty in an estimated quantity. The numerical standard deviation for the primary endpoint is not reported in the registry record. There is therefore no reported summary of the variation in CSS changes.

Why does the design matter for interpretation?

In general, random assignment can help balance both measured and unmeasured characteristics between groups, while a concurrent comparison can help distinguish changes associated with an intervention from changes that might occur over time in its absence. This study is listed as nonrandomized and single-group, with no separate control group. A before-and-after comparison can describe within-group change, but it cannot make the same controlled comparison. This is a design limitation, not a judgment about the quality of the score measurement.

Blinding is another distinct design feature. The overall masking designation is none, while the primary endpoint description specifies three independent, blinded physician assessors of images. In general, blinding outcome assessors can reduce the influence of expectations on subjective ratings. The registry does not explain the procedures used to maintain assessor blinding, whether image order was concealed, or how assessments were combined. Those implementation details are not reported in the registry record.

What can be concluded about the statistical plan?

The record lists six outcome measures and three analyses, but does not describe the statistical methods used for the primary or secondary outcomes. In general, a statistical analysis plan can specify the estimand, analysis population, model, handling of missing data, and approach to multiple outcomes. The registry record does not report such details, nor does it report a sample-size justification or interim analyses. No model, covariate adjustment, or inferential procedure should be assumed from the endpoint's mean-and-standard-deviation description alone.

The registry includes a planning illustration framework based on an observed effect, with assumptions of a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For continuous outcomes, such an illustration would express a hypothetical number of participants per arm under the stated assumptions and effect fraction. It is a planning calculation, not a count of participants observed in this single-group study and not evidence of observed power. No calculated participant-per-arm values are reported in the registry record. These assumptions also do not establish that the trial itself used that design or analysis plan.

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("Targeted Verifiable Subcision (TVS) With the Avéli")
n   <- c(68)
m   <- c(1.5)
sp  <- c(0.9)
sd  <- sp      # posted standard deviations
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  Targeted Verifiable Subcision (TVS) With the Avéli  68  1.500  0.900  1.282  1.718

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and three analyses. The recorded outcomes include the primary mean change in CSS at 3 months and secondary measures concerning GAIS improvement at 3 months and 12 months, CSS change at 12 months, and satisfaction at 3 months and 12 months. The presence of several outcomes raises a general statistical issue: when many hypotheses are assessed, the chance of at least one apparently unusual result can increase if each is interpreted without accounting for the number of comparisons. This is the general rationale for considering multiplicity.

The registry record does not report whether a multiplicity adjustment was used, whether one endpoint was formally prioritized in testing, or how the three listed analyses relate to the six outcome measures. The outcome list alone does not establish a testing hierarchy or a correction procedure. Numerical results for the listed secondary outcomes are not reported in the registry record, so neither individual findings nor cross-outcome consistency can be assessed.

The record describes the effectiveness population as modified intent-to-treat, with 68 participants, and says that the roll-in population of 6 was excluded from effectiveness analyses. It does not provide a detailed definition of the modified intent-to-treat population or report the number with observed data for each endpoint. The number of participants analyzed for each outcome is therefore not reported in the registry record.

Missing-data handling is also not reported. In general, missing follow-up measurements can affect a change analysis when participants with observed outcomes differ from those without them. The registry does not state whether missing values occurred, how they were treated, or whether sensitivity analyses were conducted. It also does not report reasons for any missing assessments. These omissions prevent evaluation of the potential influence of incomplete data on the endpoint estimates.

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 3% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse event figures separately for the modified intent-to-treat group and the roll-in group. In the modified intent-to-treat group, 68 participants were at risk, 0 had serious adverse events, and 0 deaths were recorded. In the roll-in group, 6 participants were at risk, 0 had serious adverse events, and 0 deaths were recorded. The registry lists no top serious-event terms.

The figures for other adverse events indicate 68 of 68 participants affected in the modified intent-to-treat group and 6 of 6 affected in the roll-in group. These are counts in the registry record, not descriptions of event type, duration, severity, or relationship to the procedure. The record does not provide further event terms in the listed information, so the nature and clinical context of these other adverse events cannot be characterized from it.

In general, a zero count of recorded serious adverse events means that none were recorded in the specified group during the safety reporting period represented in the record. It does not establish that an event is impossible or that the procedure has no safety risks. Interpretation also depends on follow-up duration, event definitions, and completeness of reporting; those details are not reported in the registry record. These counts describe the posted safety data and should not be read as a comparison with another treatment, because there was no separate control group.

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

The registry record documents a completed study of a single Avéli TVS procedure and defines a primary measure of change in cellulite severity. It identifies the modified intent-to-treat population as the effectiveness population and describes image-based CSS assessment by independent, blinded physician assessors. These details tell readers what the study set out to measure and how the endpoint was defined.

The record does not report the numerical primary endpoint result. It therefore does not show whether the average CSS score changed, how large any change was, how variable participants' changes were, or how precise an estimate might be. Numerical results for the secondary outcomes are also not reported in the registry record. The endpoint definitions cannot substitute for the observed results, and no direction or magnitude of effectiveness should be inferred from them.

Even if a before-and-after change were available, the single-group, nonrandomized design would limit causal interpretation. In general, observing a change after treatment does not by itself establish that the intervention caused that change. A concurrent control group can help address what would have happened over the same period in a comparison condition; this study did not have such a group. The record thus does not support a randomized comparison or an estimate of the difference between treatment and control.

The safety counts report no serious adverse events and no deaths in either recorded group, while other adverse events affected all participants listed in each group. These counts should be understood within the reporting information available. They do not provide detail about the other events or establish absence of risk. The registry record does not state follow-up completeness or provide the event descriptions needed for a fuller safety characterization.

Overall, the posted record supports a description of study design, outcome definitions, analysis populations, and reported adverse-event counts. It does not support a numerical conclusion about the primary endpoint, a comparison with an alternative, or a definitive causal claim. Those limits arise from both the absence of numerical effectiveness results and the study's single-group design.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of how endpoint definition, analysis population, and design shape interpretation. The primary outcome is a mean change in a defined score, assessed at a specified follow-up time in a named effectiveness population. The registry also distinguishes that population from a roll-in group excluded from effectiveness analyses. These details are important because an endpoint estimate is meaningful only when readers can understand what was measured and who contributed to it.

The record also illustrates why a result's estimate and precision matter together. In general, a mean change alone describes average movement, while a measure of spread and a confidence interval help readers understand variation and uncertainty. Here, the numerical primary result, standard deviation, and confidence interval are not reported in the registry record. The endpoint can be described, but its size and precision cannot be assessed.

The single-group, nonrandomized design gives a further statistical lesson: within-group change is not the same as a controlled treatment comparison. A before-and-after analysis can describe observed change, but without a concurrent comparator it cannot isolate the contribution of the procedure from other influences over time. That distinction is especially important when interpreting outcomes based on subjective ratings, even when the record describes independent, blinded image assessors.

Finally, the record lists multiple outcomes but does not report a multiplicity approach, detailed missing-data methods, or a full statistical analysis plan. These are not minor technical details: they affect how confidently readers can interpret estimates and whether results across several endpoints should be treated as confirmatory or descriptive. Since numerical effectiveness findings are not reported, those questions remain unresolved in the registry record.

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 trial-specific limitations affect interpretation. First, the study was nonrandomized and single-group, with no separate control arm. Any within-group change, if reported, would not provide a direct comparison against an untreated or alternative-treatment group. This constrains causal interpretation and makes it difficult to distinguish treatment-associated change from other influences over time.

Second, the numerical primary outcome result is not reported in the registry record. The mean change, its standard deviation, and a confidence interval are not available, so readers cannot evaluate the magnitude, variability, or precision of the primary result. Numerical secondary results are also not reported. This is a limitation of the posted results, not evidence that no analyses were conducted.

Third, the effectiveness population is described as modified intent-to-treat, but the record does not give its complete operational definition or endpoint-specific analysis counts. The roll-in group was excluded from effectiveness analyses, but the record does not report how missing measurements were handled, whether there were incomplete follow-up assessments, or whether sensitivity analyses were performed. These details matter for judging which participants contributed to each estimate.

Fourth, although the endpoint description specifies three independent, blinded physician assessors, the broader masking designation is none. The registry does not explain how assessor blinding was maintained, how individual ratings were combined, or whether agreement was assessed. It also does not report the statistical analysis plan, multiplicity handling, sample-size justification, or interim analyses.

Finally, safety reporting gives counts but limited event detail. No serious adverse events or deaths are recorded in either group, while other adverse events are recorded for all participants in both groups. The types and circumstances of those other events, and details about safety follow-up, are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: CONtrolled Focal Fibrous Band Release Method Study — NCT04743635.
• Registry record last updated 2023-06-06; status last verified 2022-06.
• Results first posted 2023-06-06.
• 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

NCT04743635 is a completed, nonrandomized, single-group device study sponsored by Revelle Aesthetics, Inc. It enrolled 74 participants with cellulite and evaluated a single Avéli device procedure for TVS. The effectiveness population was the modified intent-to-treat group of 68; a roll-in group of 6 was excluded from effectiveness analyses.

The primary endpoint was mean change from baseline to 3 months in CSS score, assessed from images by three independent, blinded physician assessors. The registry also lists GAIS, later CSS, and satisfaction outcomes. Numerical primary and secondary effectiveness results, detailed analysis methods, and missing-data procedures are not reported in the registry record.

The safety record lists 0 serious adverse events and 0 deaths in each group. Other adverse events affected 68 of 68 participants in the modified intent-to-treat group and 6 of 6 in the roll-in group. The single-group design does not provide a randomized control comparison.