Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction (NCT02873104), a randomized na study. The primary outcome is Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment.

2. Clinical Question

This question is about the difference between the groups’ recorded changes, not simply whether either group changed from its own baseline. The registry describes the measure as change in abdominal circumferential measurement at 12 weeks minus the baseline measurement. It does not state how the sign of change should be interpreted, so the numerical direction should not be translated into a claim about reduction without that information. The study also records subject assessment of improvement, subject satisfaction, and discomfort and pain during treatment. Those outcomes offer additional perspectives, but they do not replace the primary measurement or establish the same thing as a measured circumferential change.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group study. Participants were assigned to a treatment group using therapeutic settings or a sham group using non-therapeutic settings on the truSculpt radiofrequency device. The record lists enrollment of 70 and marks the study as completed. The phase is listed as NA. The sponsor is Cutera Inc.

The study began in 2016-03, and primary completion is recorded as 2016-09. The registry’s stated objective was to evaluate safety and efficacy for circumferential reduction in people with abdominal fat. It does not report how randomization was generated, whether assignment was concealed, or which people were masked. The label “single” therefore does not identify the masked party in the available record. Further protocol details, including eligibility criteria, are not reported in the registry record.

The posted primary outcome is a continuous measure: change in abdominal circumferential measurement, in cm, at 12 weeks post-treatment relative to baseline. The treatment arm has a posted mean of 1.9 with standard error 0.1, based on 46; the sham arm has a mean of 0.0 with standard error 0.1, based on 23. The registry also posts secondary outcomes concerning subject assessment, satisfaction, and discomfort and pain. Their results are recorded as continuous means with standard deviations.

There are no reported analyses in the registry record, and it does not provide a detailed statistical analysis plan, the original sample-size justification, or the analysis populations. The posted comparisons can be read as simple unadjusted recalculations from summary statistics, rather than as a description of a documented sponsor analysis. The randomization label supports understanding the intended comparison, but without operational details it does not resolve questions about implementation or how participants were handled in the analyses.

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 Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment, measured over 12 weeks.

The primary endpoint is the change in abdominal circumferential measurement at 12 weeks post-treatment, expressed in cm and described as the 12-week measurement minus the baseline measurement. The registry presents the treatment and sham group means and their difference. The treatment mean is 1.9 cm and the sham mean is 0.0 cm; the reported difference is 1.9 cm.

A baseline-to-follow-up change measure is used to express how a participant’s measurement differs from their own starting measurement. Comparing those changes between randomized groups can help distinguish a pattern associated with assignment to therapeutic settings from change observed under the sham condition. That is the statistical role of the endpoint; it does not by itself establish why a difference arose or whether the magnitude is important to participants.

The registry does not report the measurement procedure, who took the measurements, the sign convention for change, or a threshold for a meaningful change. In particular, although the study title and objective refer to reduction, the endpoint description does not say whether a positive posted change represents a reduction or an increase. The values should therefore be read as the recorded change and difference, without assigning an unreported direction of benefit. The time point is 12 weeks, so the endpoint concerns that follow-up rather than persistence beyond it.

7. Results Posted in the Registry

• Treatment: mean 1.90 versus 0.00 on control; difference 1.90 (95% CI 1.62 to 2.18), standardized effect d = 3.06; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Treatment: mean 2.40 versus 1.00 on control; difference 1.40 (95% CI 0.72 to 2.08), standardized effect d = 1.18; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Treatment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Treatment: mean 4.10 versus 3.30 on control; difference 0.80 (95% CI 0.37 to 1.23), standardized effect d = 0.96; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Treatment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Subject Discomfort and Pain Levels During Treatment

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Treatment: mean 5.75 versus 1.10 on control; difference 4.65 (95% CI 4.36 to 4.94), standardized effect d = 6.12; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Treatment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes cover subject assessment of improvement, subject satisfaction, and discomfort and pain during treatment. Across these measures, the posted treatment-group means are higher than the corresponding sham-group means. That shared numerical pattern should not be interpreted as a common direction of benefit: a higher assessment or satisfaction value and a higher discomfort or pain value do not have the same meaning.

The secondary measures relate to the primary result by adding subject-reported perspectives and treatment experience alongside the recorded circumferential measurement. They may provide context for how participants assessed improvement or experienced treatment, but they do not verify the primary measurement, explain its sign convention, or establish that a particular change is meaningful. Nor can a subject-reported rating be used as a substitute for the primary endpoint.

Each posted comparison is unadjusted, and the reported p-values are <0.001. The registry does not report an analysis plan, a multiplicity adjustment, or analyses for these outcomes. When several outcomes are examined, the chance of at least one apparently strong result can increase if no adjustment or hierarchy is used. This general concern means that individual unadjusted secondary findings carry less weight than a result interpreted within a prespecified plan. The record does not establish whether the secondary outcomes were confirmatory or exploratory.

The registry also does not provide scale descriptions, validation information, or thresholds for meaningful changes on the subject-reported measures. Without those details, the means and differences can be described numerically, but their practical meaning is uncertain. The secondary findings are best treated as additional descriptive evidence, with their interpretation limited by the absence of documented analysis and measurement details.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
• Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
• Subject Discomfort and Pain Levels During Treatment

9. Statistical Interpretation

10. Statistical Methods Explained

The registry posts continuous outcomes as means. The primary endpoint is reported in cm with standard errors, while the secondary outcomes are reported in scale units with standard deviations. These summaries describe different aspects of the data and should not be treated as interchangeable.

What does a mean difference represent?

For the primary outcome, the reported mean difference compares the mean change in the treatment group with the mean change in the sham group. The posted means are 1.9 cm and 0.0 cm, and the reported contrast is 1.9 cm. This contrast is a between-group summary. It is not a count of participants who changed, and it does not describe how every participant’s measurement changed. Because the registry does not explain the sign convention, the positive value should not be assigned a direction such as “reduction” or “increase.”

General statistical explanation: a mean summarizes the central value of a continuous measure, but it does not show the full spread of individual observations. Participants can have values above or below the mean. The mean alone cannot indicate whether most participants had similar results or whether observations varied widely.

How do standard error and standard deviation differ?

The primary group summaries use standard errors of 0.1 in both arms. A standard error describes the precision of an estimated mean; it is not a direct description of the spread of participant measurements. The secondary outcome summaries use standard deviations, which describe variation among observed values around a group mean. Thus, the primary and secondary spread values answer different questions.

General statistical explanation: the standard error is affected by both the variability of observations and the amount of information contributing to the estimate. It is commonly used when estimating uncertainty around a mean. A standard deviation instead expresses how dispersed the observations are. The registry does not provide the primary outcome’s standard deviation, nor does it report the data-level details needed to inspect the distribution.

What does the interval around a difference convey?

The primary mean difference has reported limits of 1.623 and 2.177 cm. General statistical explanation: a confidence interval represents uncertainty around an estimate under the assumptions of the method used to construct it. A narrower interval indicates greater precision on the scale being measured, while a wider interval indicates more uncertainty. The confidence level and construction method for this interval are not reported in the registry record, so they should not be inferred.

The interval excludes zero, and the unadjusted p-value is <0.001. General statistical explanation: a p-value describes how compatible observed data are with a specified null hypothesis under a statistical model; it is not the probability that the null hypothesis is true, nor a measure of clinical importance. The registry does not report a multiplicity adjustment, so the p-value should be understood as unadjusted. It is not evidence that every individual experienced a change or that the estimated difference has a particular practical meaning.

What does “recalculated” mean in this context?

The posted comparisons are simple, unadjusted recalculations from the summary statistics. They are not a substitute for an analysis plan or for participant-level analyses. A recalculation can make the group contrast and its uncertainty easier to read, but it cannot account for information absent from the summaries, such as participant-level distributions, missing observations, or an adjusted model. No analyses are reported in the registry record, so the comparison should not be presented as a documented sponsor analysis. The discrepancy indicator is false.

General statistical explanation: adjustment can be used to account for prespecified factors, and different statistical models can produce different estimates or uncertainty measures. Randomization is intended to support a fair group comparison, but the record does not specify whether any adjustment was planned or performed. It would be inappropriate to infer such details from the reported means alone.

Why can over-dispersion matter?

General statistical explanation: over-dispersion arises when observed variation is greater than a model expects. If a model assumes too little variability, its uncertainty estimates can be too small and its statistical evidence can appear stronger than warranted. This issue is especially relevant for count outcomes and some forms of categorical data. The primary outcome in this study is continuous, and the registry does not report a model-based analysis that would permit an assessment of over-dispersion. It is therefore a general consideration rather than a documented issue in this trial.

The posted summary statistics also do not show distribution shape, outliers, or within-person measurement variability. The registry does not report whether the analysis checked assumptions or used robust methods. These omissions do not invalidate the numerical summaries, but they limit independent evaluation of how well the simple recalculation represents the underlying data.

11. Confidence Intervals and Precision

The primary mean difference is 1.9 cm, with reported interval limits of 1.623 and 2.177 cm. These limits express the uncertainty attached to the estimated contrast according to the calculation used. Because the interval does not include zero, the posted result is compatible with a nonzero group difference under that calculation. The unadjusted p-value is <0.001.

The interval is useful because the estimate alone would not show how precisely the contrast was estimated. Its limits remain on the circumferential-measurement scale, which makes them more directly interpretable than a p-value for the size of the contrast. However, the registry does not report the confidence level or method used to form the interval. Those details should not be inferred from the numerical limits.

Precision is not the same as clinical importance. The registry does not report a threshold for a meaningful change, nor does it explain whether the positive sign represents reduction. The interval therefore quantifies uncertainty around the recorded contrast, but cannot establish whether the values are important to participants or how to interpret their direction.

The arm summaries report standard errors of 0.1 for both means. These describe precision of the group mean estimates, not the range of participant-level measurements. No distributional information is posted for the primary endpoint. The available interval also does not address uncertainty from missing data, analysis-population choices, or unreported design and analysis decisions.

In general, confidence intervals are sensitive to the assumptions and data used to construct them. Here, the posted comparison is an unadjusted recalculation from summary statistics, and the registry record does not document the interval method. The limits should be read as the uncertainty reported for that comparison, rather than as resolving the unanswered questions about measurement coding, analysis procedures, or practical significance.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is set as a stated fraction of the observed effect. These are planning illustrations based on the observed effect, not the trial’s original design assumptions; the original sample-size justification is not reported in the registry record.

The 80% power column means the illustrated number of participants per arm for a planned study to have an 80% chance of detecting the specified effect under the listed assumptions, if that effect and those assumptions were correct. The 90% power column gives the corresponding illustration for a 90% chance. These are prospective planning concepts, not descriptions of the probability that the completed trial found a result.

The rows represent planning for 100%, 75%, and 50% of the observed effect. As the target effect becomes smaller, more participants are generally needed to distinguish it from random variation at the same significance level and power target. The listed values are tied to the observed effect in this trial, so they should not be treated as a general recommendation or as evidence that a future study will reproduce the observed contrast.

This is not observed power. It is a planning illustration, and it does not replace the confidence interval or the posted comparison. The registry record does not report the assumptions originally used to choose enrollment.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 1.900; pooled standard deviation σ = 0.620.
2. n = 2 × (1.96 + 0.842)² × 0.620² / 1.900² = 1.7, rounded up to 2 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 1.9                      # observed difference in means
sigma <- 0.620062587115445                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2873104)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 2 (80% power), 3 (90% power)
 75% of observed effect: n per arm = 3 (80% power), 4 (90% power)
 50% of observed effect: n per arm = 7 (80% power), 9 (90% power)
power.t.test: 3 
Simulated power at n = 2 per arm: 0.395 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and secondary outcomes, but does not report a statistical analysis plan specifying how the outcomes were prioritized or how multiple comparisons were handled. The posted p-values are unadjusted. An unadjusted p-value addresses an individual comparison under its statistical assumptions; it does not account for examining multiple endpoints or making multiple comparisons.

General statistical explanation: when researchers test several hypotheses, the possibility of at least one result appearing statistically notable by chance can grow. A prespecified hierarchy, adjustment method, or clear exploratory designation can help readers understand how to interpret a collection of results. None of these details is reported in the registry record. It is therefore not possible to tell whether the outcome hierarchy was prespecified or whether multiplicity was considered in the sponsor’s intended analysis.

The record reports no analyses, and it does not specify which participants were included in each endpoint analysis. The primary endpoint counts are 46 for treatment and 23 for sham, while the enrollment entry is 70. The registry does not explain the relationship between those figures, report participant flow, or state how missing measurements were handled. It also does not report whether an intention-to-treat, per-protocol, or other analysis population was used. Those terms should not be assigned to the posted results without documentation.

Missing-data handling can matter because an analysis may be affected if outcomes are unavailable for some participants, particularly when the reasons for missingness differ across groups or relate to the outcome. General statistical explanation: methods such as complete-case analysis, imputation, or sensitivity analyses rely on assumptions and can lead to different uncertainty estimates. The record does not identify any approach or provide enough information to assess whether missing data occurred.

The absence of those details does not establish that data were missing or that the analysis was biased. It means the registry record does not allow readers to evaluate those possibilities. More complete reporting of prespecified analysis choices, endpoint hierarchy, multiplicity handling, participant flow, and analysis populations would make the results easier to assess.

15. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse event figures show 0 affected participants in the treatment group and 0 in the sham group. The registry lists 47 as at risk in treatment and 23 as at risk in sham for this measure. The record does not list any serious adverse event terms among the top serious terms.

For other adverse events, the record lists 47 affected among 47 at risk in treatment and 23 affected among 23 at risk in sham. These are event-category counts as recorded; they do not describe event type, severity, duration, or relationship to the device. The registry does not report deaths, so mortality information is not reported in the registry record.

These figures should not be taken alone as a complete safety assessment. The registry does not provide detailed event descriptions or explain the ascertainment and classification procedures. A count of zero serious adverse events in the posted record does not establish that no safety risks exist, and the counts for other adverse events do not show how burdensome or clinically important those events were. The safety results should be read as the reported counts, with these limitations in mind.

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

The posted data show a mean difference of 1.9 cm in change in abdominal circumferential measurement between the therapeutic-settings group and the sham group at 12 weeks. The reported interval runs from 1.623 to 2.177 cm, and the unadjusted p-value is <0.001. Those statistics describe a group-level contrast and its reported uncertainty. They do not show the result for every participant.

The result does not, by itself, establish that the measurement difference represents a reduction. Although the study title and objective refer to circumferential reduction, the endpoint description says the follow-up measurement is minus baseline and does not define the sign convention. The direction of the recorded contrast should therefore remain a numerical direction unless the measurement coding is clarified.

The statistical evidence also does not determine whether the difference is important to participants. The registry does not report a threshold for meaningful change or enough information about measurement methods to assess how the measurement relates to participant experience. The subject assessment and satisfaction outcomes may add context, but they are unadjusted secondary comparisons and are not interchangeable with the primary measure.

The record does not report the original sample-size justification, detailed analysis plan, missing-data approach, or analysis populations. It also does not report the confidence-interval method or level. These gaps limit assessment of assumptions and robustness. The adverse-event counts describe what is posted but do not establish overall safety or rule out risks not represented by those counts.

Accordingly, the result is best understood as a statistically distinct, unadjusted difference in the posted primary summaries at the specified follow-up, with important limits on clinical interpretation. It should not be extended to longer-term outcomes, other populations, other devices, or settings not described in the registry record.

17. Why This Trial Matters Statistically

This trial is statistically interesting because it places therapeutic device settings against a sham condition in a randomized, parallel-group design and posts a continuous primary measurement at a defined follow-up. A sham comparator can help distinguish the pattern observed with therapeutic settings from changes occurring under a non-therapeutic device condition. The registry’s randomization label is relevant to that comparison, although operational details about assignment and masking are not reported.

The primary result combines a group difference with an interval estimate and an unadjusted p-value. That combination encourages readers to consider both the estimated magnitude and its uncertainty, rather than relying on a significance threshold alone. The interval is reported in the original measurement units, but the missing sign convention and absence of a meaningful-change threshold constrain interpretation of what the contrast means in practice.

The secondary outcomes also illustrate why endpoint roles matter. Participant assessments and experience measures can complement a physical measurement, but several unadjusted comparisons do not have the same evidentiary status as a clearly defined primary endpoint analyzed under a prespecified plan. The registry does not report the hierarchy or multiplicity approach needed to judge that distinction fully.

Finally, the record demonstrates the importance of complete statistical reporting. Details about participant flow, missing data, measurement procedures, analysis populations, and the confidence-interval method would help readers judge precision and robustness. The posted numbers allow a careful description of the recorded comparisons, while the unreported methodological context limits stronger conclusions.

18. 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 important trial-specific limitation is that the registry does not explain how positive and negative changes in abdominal circumference are coded. The study title and objective refer to reduction, but the endpoint description defines follow-up minus baseline without saying which sign corresponds to reduction. This makes the direction of the primary numerical contrast difficult to translate into the stated study objective.

The registry does not report how circumference was measured, who performed measurements, or whether measurement procedures were standardized. It also gives no threshold for a meaningful change. Those omissions limit assessment of measurement reliability and the practical interpretation of the mean difference and its interval.

The record lists randomized, single-masked, and parallel-group design features, but does not identify who was masked or describe randomization methods, allocation concealment, or adherence procedures. It does not report eligibility criteria or participant characteristics beyond the abdominal-fat condition. Generalizability beyond the population represented by the enrolled participants cannot be assessed from the posted record.

For analysis, no analyses are reported. The record does not describe the original sample-size justification, analysis populations, missing-data handling, confidence-interval construction, or multiplicity strategy. The primary endpoint analysis counts differ from the enrollment entry, and participant flow explaining this is not reported. These points do not prove a flaw, but they prevent a full appraisal of how the posted summaries were generated and how robust they are.

The follow-up described for the primary and subject-reported outcomes is 12 weeks. Outcomes beyond that timeframe are not reported in the registry record. Adverse-event categories are posted as counts without detailed event descriptions or mortality information. These limitations constrain conclusions about longer-term outcomes and safety.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction — NCT02873104.
• Registry record last updated 2018-02-28; status last verified 2017-02.
• Results first posted 2018-02-28.
• 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.

22. Record Summary

The registry describes a completed, randomized, single-masked, parallel-group study of the truSculpt radiofrequency device for circumferential reduction in people with abdominal fat. Treatment used therapeutic settings and the sham condition used non-therapeutic settings. Enrollment is recorded as 70; the study began in 2016-03 and reached primary completion in 2016-09. The phase is listed as NA.

The primary endpoint was change in abdominal circumferential measurement from baseline at 12 weeks. The posted mean difference is 1.9 cm, with interval limits of 1.623 and 2.177 cm and an unadjusted p-value of <0.001. Secondary outcomes address subject assessment, satisfaction, and discomfort and pain. Serious adverse event counts are 0 in each group; other adverse events are recorded for all participants listed at risk in each group.

The registry does not report analyses, detailed analysis methods, missing-data handling, participant flow, or a meaningful-change threshold. It also does not clarify the sign convention for the primary measurement. These omissions limit interpretation beyond the numerical summaries.