Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction (NCT05896696), a na na study. The primary outcome is Change in Waist Circumference.

2. Clinical Question

The study asks whether waist circumference changes after a single BeShape One device treatment, comparing measurements at follow-up with baseline. Its primary endpoint is the mean change in waist circumference, measured in centimetres, at the 12-week follow-up. The study also lists subject improvement and satisfaction, investigator satisfaction, and subject comfort or pain among its outcomes.

This design can describe changes observed over time among participants who received treatment. Without a control group, it cannot by itself distinguish changes associated with treatment from changes that might occur for other reasons, including measurement variation or the passage of time. The registry record does not report a numerical estimate of the primary endpoint, so the size and direction of the observed change cannot be assessed from the recorded details.

3. Trial Design

The registry identifies this as a prospective, single-group clinical study of the BeShape One device. It records enrollment of 81 and a completed status. The recorded study dates are 2022-04-28 for the start and 2023-03-16 for primary completion. The phase is listed as NA. Allocation is also listed as NA, and masking is recorded as NONE.

Participants were to receive a single device treatment at the baseline visit and return for follow-up visits at 6 and 12 weeks after treatment. The study summary says researchers would compare follow-up results with baseline. Thus, the comparison is within the treated group over time, rather than between a treatment group and a concurrent control group. The record does not describe a random allocation process or a masked assessment procedure.

The primary outcome is change in waist circumference, with the primary endpoint specified at baseline and 12 weeks. The registry lists secondary outcomes of change in waist circumference, subject improvement, subject satisfaction, investigator satisfaction, and subject comfort or pain. It records 6 outcome measures and 2 analyses, but the registry entries recorded do not explain how those entries map to each endpoint or analysis.

Enrollment is not necessarily the same as the number of participants with complete endpoint data. The safety record gives 72 as the number at risk for both serious and other adverse events. The registry record does not explain the difference between that safety denominator and the enrollment count, nor does it report the number included in the primary endpoint analysis. A detailed protocol, eligibility criteria beyond the age range in the study summary, and the statistical analysis plan 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.

Overall Study

Reasons for not completing this period:

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 Waist Circumference, measured over Baseline and 12 weeks.

The primary endpoint is mean change in waist circumference, measured in centimetres, from baseline to the 12-week follow-up. It represents the average within-participant difference between the baseline measurement and the measurement at the specified follow-up. The registry describes the endpoint as a mean and identifies standard deviation as its measure of dispersion.

Waist circumference is a continuous measurement: it can take a range of values rather than falling into a small set of categories. Using a continuous endpoint allows the analysis to describe the magnitude of measured change, rather than only whether participants cross a defined threshold. A mean summarizes the central value of participant-level measurements, while a standard deviation describes how spread out those measurements are around the mean. These are general statistical meanings, not a report of the study’s numerical results.

A baseline comparison is useful for describing how measurements changed over follow-up among the treated participants. However, a change from baseline is not itself a treatment-versus-control contrast. Without a separate control group, the endpoint cannot establish how much of any observed change would have differed from change over the same period without treatment.

The registry record specifies the endpoint and its timeframe but does not report the mean change, its standard deviation, a confidence interval, or a p-value. It therefore does not allow readers to assess the observed magnitude, variability, or precision of the primary result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous primary outcome summarized as a mean, with standard deviation as the dispersion measure. It describes change in waist circumference in centimetres from baseline to 12 weeks. The following concepts explain how such statistics are commonly interpreted; they do not identify methods actually used in this study unless the registry record states them.

What does a mean change represent?

For each participant with the necessary measurements, a change score can be defined by comparing the follow-up measurement with that participant’s baseline measurement. A mean change then summarizes those individual changes across the participants included in the analysis. The sign and size of that mean would describe the average direction and magnitude of change according to the subtraction convention used. The registry record does not specify that convention or report the mean change itself.

A mean is sensitive to the values included in the analysis. Participants with unusually large changes can influence it more than they influence a median. The registry identifies the mean as the parameter of interest, but does not report the distribution of individual changes, a median, or other summaries that would show whether the mean represents a broadly shared pattern or is influenced by a smaller number of observations.

What does the standard deviation describe?

Standard deviation describes the spread of measurements around their mean. For a change outcome, it would help show how much individual participants’ changes varied around the average. It is not the same as a confidence interval: the standard deviation describes participant-level variability, while a confidence interval concerns uncertainty about an estimated quantity. The registry identifies standard deviation as the dispersion measure but does not report its numerical value for the primary outcome.

How does a confidence interval help?

General statistical explanation: a confidence interval gives a range of estimates compatible with the observed data and the assumptions of the interval method. It can convey precision and the range of effects that remain plausible under that method. Its width is influenced by variability, the number of observations included, and the analysis method. A confidence interval does not correct design limitations, remove bias, or establish a causal effect. No confidence interval for the primary endpoint is reported in the registry record.

What would a p-value tell a reader?

General statistical explanation: a p-value describes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the statistical model were true. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of a result. Interpretation depends on the hypothesis, analysis method, and any multiplicity considerations. The registry record does not report a primary-outcome p-value or identify the test used.

Why does the single-group design matter?

A within-participant comparison uses measurements from the same participants at baseline and follow-up. In general, this can account for stable differences between participants when describing change. It does not supply the missing counterfactual: the change those same participants would have experienced without treatment. A control group can help estimate that contrast, depending on how it is designed and analyzed. This study is recorded as SINGLE GROUP, so its baseline comparison should not be interpreted as a randomized or controlled treatment effect.

The record does not report whether the primary analysis used a paired statistical test, a model, an adjustment for baseline, or another method. It also does not describe the handling of missing follow-up measurements, the analysis population, or assumptions about the distribution of change scores. Those details are not reported in the registry record and should not be inferred from the endpoint description alone.

How should planning illustrations be understood?

The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For non-time-to-event outcomes, those illustrations are expressed as participants per arm for 80% power or 90% power; time-to-event illustrations use a total number of events. The record says these are planning illustrations, not the trial’s own design. They are not observed power and do not change the fact that the study is single-group. No numerical illustration values are included in the registry entries used for this analysis, and the primary outcome estimate needed to evaluate an observed effect is not reported in the registry record.

More generally, planning calculations depend on assumptions about the effect to detect, variability, allocation, significance level, and analysis. An illustration based on a fraction of an observed effect is conditional on that chosen effect and does not demonstrate that a study had adequate or inadequate power. Since the numerical primary outcome result is not reported, the planning assumptions should not be treated as evidence about the result of this study.

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("BeShape One Device Treatment")
n   <- c(72)
m   <- c(-1.87)
sp  <- c(2.62)
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  BeShape One Device Treatment  72  -1.870  2.620  -2.486  -1.254

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary waist circumference endpoint and secondary outcomes covering change in waist circumference, subject improvement, subject satisfaction, investigator satisfaction, and subject comfort or pain. It records 6 outcome measures and 2 analyses. The record does not explain how these entries correspond to distinct timepoints, measures, or analyses, or identify which results were designated as confirmatory.

Multiplicity is the general issue that arises when several outcomes, timepoints, or statistical tests are examined. Considering more tests can increase the chance of finding at least one apparently notable result by chance. Possible approaches include prespecifying a primary analysis or adjusting interpretation for multiple comparisons. The registry record does not report whether a multiplicity adjustment or other strategy was planned or used. No specific procedure should be inferred.

The registry record does not report the number of participants with primary endpoint measurements at baseline and 12 weeks, or how missing measurements were handled. It does not describe reasons for missing data, imputation, sensitivity analyses, or whether participants were analyzed according to a defined analysis population. These details matter because an analysis limited to participants with complete measurements may differ from an analysis that accounts for missing outcomes in another way.

Enrollment is recorded as 81, while the safety denominators are 72. The record does not explain that difference or state whether either count reflects the population used for the primary efficacy analysis. Without the analysis population and missing-data details, the completeness and representativeness of the outcome analysis cannot be assessed from the registry record.

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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: laparoscopically assisted hysterectomy (1.4%).

The safety record lists 72 participants at risk for serious adverse events and 1 participant affected. It lists 72 at risk for other adverse events and 47 affected. The recorded number of deaths is 0. The top serious-event term is laparoscopically assisted hysterectomy, reported as 1.4%.

These are descriptive registry counts, not evidence by themselves that an event was caused by the device. The record does not report event narratives, timing, severity criteria, relatedness assessments, or whether the serious event is represented by the listed term. Those details are not reported in the registry record. The term should therefore be read as the listed event description, not as an explanation of cause.

The two adverse-event categories should be interpreted as recorded categories rather than combined or compared as though their definitions and reporting rules were fully described. The fact that 72 participants are listed at risk for each category does not establish that all 72 had complete follow-up or that event surveillance was identical across categories. The registry record does not describe the monitoring period or methods for collecting events.

The 0 deaths entry is the recorded count for the safety group; it should not be extended beyond that reported count. Safety counts also do not establish the absence of unreported events or quantify risk relative to an untreated group. There is no concurrent control group in this single-group study.

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

The registry record establishes that a prospective, single-group study of the BeShape One device was completed and that its intended primary outcome was waist circumference change from baseline to 12 weeks. It also identifies follow-up at 6 weeks in the study summary and lists participant- and investigator-reported secondary outcomes. The record gives safety counts and the number at risk for each adverse-event category.

It does not report the numerical primary endpoint result. Readers therefore cannot determine the mean change, its variability, or the precision of the estimate from the registry entries. No reported confidence interval or p-value is available to support an inference about statistical uncertainty. The record also does not provide numerical results for the secondary outcomes.

Even if a within-group change were reported, it would describe change among participants who received treatment; by itself, it would not show how much change was caused by treatment. The absence of a separate control group limits causal interpretation, because changes over time and other influences cannot be separated from treatment-associated change using this comparison alone. This is a general limitation of before-and-after single-group designs.

The safety entries show 1 serious adverse event among 72 at risk, 47 other adverse events among 72 at risk, and 0 deaths. They are descriptive, and the registry record does not establish device causation. The listed serious-event term and percentage add descriptive detail but do not explain the event’s relationship to treatment.

In short, the record describes the study question, design, endpoint, and selected safety counts, but it does not supply the efficacy results needed to characterize the observed waist circumference change. It supports neither a numerical estimate of the endpoint nor a controlled causal conclusion. Missing information about analysis methods, follow-up completeness, and outcome results further limits statistical interpretation.

14. Why This Trial Matters Statistically

This study illustrates an important distinction between recording an outcome and reporting its result. The registry specifies a continuous endpoint, its unit, the summary parameter, the dispersion measure, and the 12-week timeframe. Those details help define what the study intended to measure. Without the numerical estimate and its uncertainty, however, the endpoint definition alone cannot show the magnitude or precision of the observed change.

The single-group design is also statistically important. Comparing follow-up with baseline can describe change in the treated participants, but it does not estimate a treatment-versus-control difference. That distinction is central when interpreting any before-and-after study: observed change and causal effect are not interchangeable. Allocation is recorded as NA, and no control group is described.

The record also highlights why analysis details matter. The primary outcome is a mean change, but the analysis method, analysis population, missing-data approach, and multiplicity strategy are not reported in the registry record. Each can influence how an estimate should be interpreted. The safety denominators also differ from the enrollment count, with no explanation of that difference in the recorded details.

Finally, descriptive safety counts need context. Counts of serious and other adverse events can inform readers about what was recorded, but do not establish causation or permit comparison with an untreated group in this design. Transparent numerical outcome reporting, alongside denominators and analysis methods, is necessary for readers to judge both the findings and their limitations.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most direct limitation for interpreting efficacy is that the registry record does not report numerical waist circumference results. Without the primary estimate, its variability, or an interval describing its precision, the endpoint cannot be evaluated quantitatively. Numerical secondary outcome results are also not reported in the recorded details.

The study is single-group and has no separate control arm. A baseline-to-follow-up comparison can describe change over time, but it cannot distinguish treatment-associated change from other time-related or measurement-related influences. The registry records masking as NONE; it does not describe whether outcome assessors were masked or what steps were used to limit measurement or reporting bias.

The study summary gives an age range of 18 to 65, but broader eligibility details and participant characteristics are not reported in the registry record. The number enrolled is 81, while the safety denominator is 72; the reason for that difference is not reported. The primary outcome analysis denominator and completeness of follow-up are also not reported.

The record does not describe the statistical test or model, missing-data handling, analysis population, or multiplicity strategy. It does not provide enough detail to assess whether the analysis followed a prespecified plan. Although the registry reports serious and other adverse-event counts, it does not give detailed event attribution or monitoring procedures. These limitations restrict interpretation of efficacy, precision, completeness, and safety context.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction — NCT05896696.
• Registry record last updated 2024-10-16; status last verified 2024-10.
• Results first posted 2024-10-16.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a completed prospective, single-group study of the BeShape One device, with enrollment of 81. The study summary says participants received a single treatment at baseline and returned for follow-up at 6 and 12 weeks. The primary endpoint is mean waist circumference change in centimetres from baseline to 12 weeks, with standard deviation identified as the dispersion measure.

Allocation is listed as NA and masking as NONE. The registry lists secondary outcomes related to waist circumference change, subject improvement and satisfaction, investigator satisfaction, and subject comfort or pain. It records 6 outcome measures and 2 analyses.

For safety, 72 participants are listed at risk for serious events and 1 as affected; 72 are listed at risk for other events and 47 as affected. The death count is 0. The top serious-event term is laparoscopically assisted hysterectomy, reported as 1.4%.

Numerical efficacy results, analysis details, missing-data methods, and the explanation for the difference between enrollment and safety denominators are not reported in the registry record.