This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body (NCT00953160), a na na study. The primary outcome is Change in Circumference (cm).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00953160 |
| Phase | NA |
| Condition | Cellulite |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 76 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cutera Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes a study in people with localized areas of the body, with cellulite listed as a condition. It does not report further eligibility details or describe the participants in enough detail to establish who the findings might represent.
Intervention
The intervention was the Cutera Radio Frequency Device. The arm description says that an abdomen, flank or thigh was treated with the RF device.
Comparator
There was no comparison group listed. The registry identifies the study as single-group, with allocation recorded as NA and masking as none. Consequently, the record does not set up a like-for-like control comparison.
Primary question
The primary question was whether circumference changed from baseline to 6 months post final treatment. The outcome was specified as mean change in centimeters, with standard deviation as the measure of dispersion. The registry record does not report the observed change or an analysis of it.
This is a question about change over time in a treated group, not a randomized comparison of RF treatment against an untreated or alternative-treatment group. A change in the group’s circumference could be described if the outcome results were available, but a before-and-after comparison alone would not establish that the device caused the change. Other influences over time cannot be separated from treatment without a suitable comparison or other design features, which are not reported in the registry record.
3. Trial Design
The registry describes a pilot study of the Cutera RF device for reduction in size of localized areas of the body. It lists enrollment of 76 and identifies the design as single-group. The intervention arm is called RF treatment, and its description specifies treatment of an abdomen, flank or thigh with the RF device. The condition listed is cellulite.
The record gives allocation as NA and masking as none. It does not list a control arm or a randomized allocation process. These features matter for interpretation: the study can describe measurements among treated participants, but it cannot provide a direct randomized estimate of how those measurements compare with an untreated group or another intervention. A single-group design also cannot distinguish a treatment-associated change from changes that might occur over time for other reasons.
The study phase is listed as NA. The start is recorded as 2009-04, primary completion as 2010-07, and status as terminated. The registry record does not report why the study was terminated or provide further operational details. It also does not report a protocol explanation of the pilot design, recruitment process, treatment schedule, eligibility criteria, or any planned sample-size justification.
The stated primary outcome is change in circumference, measured in centimeters, from baseline to 6 months post final treatment. Subject satisfaction and the number of participants with adverse events are listed as secondary outcomes. Although the registry lists 76 enrolled, the adverse-event results separately identify 49 as at risk in the RF treatment group. The record does not explain the relationship between these figures, so they should not be treated as interchangeable descriptions of the analysis population.
No outcome analyses are listed. Therefore, the design and intended measurements can be described, but the posted results do not establish the magnitude, precision, or direction of any change in circumference or satisfaction.
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
| Stage | Radiofrequency (RF) Treatment |
|---|---|
| STARTED | 76 |
| COMPLETED | 49 |
| NOT COMPLETED | 27 |
Reasons for not completing this period:
| Reason | Radiofrequency (RF) Treatment |
|---|---|
| Lost to Follow-up | 23 |
| Withdrawal by Subject | 4 |
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.
| Characteristic | Unit | Radiofrequency (RF) Treatment |
|---|---|---|
| Participants analysed | 76 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 76 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 43 (SD 8.5) |
| Sex: Female, Male: Female | Participants | 69 |
| Sex: Female, Male: Male | Participants | 7 |
| Region of Enrollment: United States | participants | 76 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Circumference (cm), measured over Baseline and 6 months post final treatment.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Centimeters (cm) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in circumference, measured in centimeters, from baseline to 6 months post final treatment. It is specified as a mean, with standard deviation as the measure of dispersion. Circumference is a continuous measurement: it can take a range of values rather than being limited to categories such as event or no event.
In general, measuring the same outcome at baseline and a later follow-up allows investigators to describe how the measurement differs over time within the study group. The mean summarizes the group’s average change, while the standard deviation describes how much individual measurements vary around that average. These summaries answer different questions: the mean concerns the average level of change, and the standard deviation concerns variability among measurements. Neither one, by itself, describes the uncertainty around the estimated mean; that is usually conveyed by an inferential measure such as a confidence interval.
The specified follow-up point is 6 months post final treatment, so the endpoint concerns change assessed at that time rather than an immediate response. The registry record does not state how circumference was measured, who performed the measurements, whether measurements were repeated, or how multiple treated body areas were handled in the outcome analysis. Those details can affect the consistency and interpretation of a continuous measurement.
The registry identifies the endpoint but does not report its observed mean change, standard deviation, sample size for the outcome analysis, or an inferential analysis. The clinical size and precision of the change therefore cannot be evaluated from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main interpretive constraint is that the registry record contains no outcome analyses. It lists circumference change as the primary endpoint and describes the intended timing and summary measure, but it does not report the observed mean change, its standard deviation, a confidence interval, or a test result. No conclusion about the direction or size of the measured change can be drawn from the posted results.
The design is single-group, with allocation recorded as NA and masking as none. A single-group before-and-after study can describe changes among the participants with measurements, but it does not by itself estimate what would have happened over the same period without the intervention. Even if an observed change had been reported, it could not be attributed to the RF device solely on the basis of this design. The record does not list a control group against which to separate treatment-associated change from other temporal influences.
Enrollment is listed as 76, while the safety results identify 49 people at risk in the RF treatment group. These figures refer to different registry entries, and the record does not explain their relationship. The outcome-analysis population and the number with primary endpoint measurements are not reported in the registry record. As a result, the enrollment figure cannot be used as a substitute for the denominator for the circumference analysis.
The safety entries report 0 serious adverse events among 49 at risk and 3 other adverse events among 49 at risk. These are descriptive counts in the registry record. They do not supply information about event types for the other adverse events, timing, attribution, or comparative risk. The deaths entry is not populated, so deaths are not reported in the registry record. The serious-event terms are also not listed.
The record lists subject satisfaction and the number of participants with adverse events as secondary outcomes, but it does not report their outcome analyses. It is therefore not possible to assess satisfaction results, the completeness of outcome reporting, or the precision of any secondary estimate. The record lists 3 outcome measures and 0 analyses.
In general, estimates are more informative when accompanied by measures of uncertainty and a clear account of the participants included in each analysis. Since the primary result and its uncertainty are not reported, there is no basis for judging statistical precision, and no reported result to compare with a threshold of practical importance. The posted information supports a description of the study design and the recorded safety counts, not an estimate of treatment effect.
9. Statistical Methods Explained
The registry specifies a continuous primary endpoint summarized as a mean, with standard deviation as the dispersion measure. It also records a single-group design and no masking. The statistical methods used to analyze the primary or secondary outcomes are not reported in the registry record. The explanations below give general context for reading the measures and design, rather than describing an analysis that the record confirms was performed.
What does a mean change describe?
In general, a mean change summarizes the average difference between each participant’s baseline measurement and the later measurement included in the analysis. It is useful for expressing the average direction and size of change on the outcome’s measurement scale. The standard deviation describes the spread of individual values around the mean; it is not the same as the standard error or a confidence interval. A mean alone can hide substantial variation between participants, while a standard deviation alone does not identify the average change.
The registry names baseline and 6 months post final treatment as the measurement points, but it does not report the endpoint values. It also does not explain whether the outcome was calculated at the participant level, how multiple treated areas were represented, or what happened when a later measurement was unavailable. The analysis method for repeated measurements is not reported in the registry record.
What would uncertainty measures add?
In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the statistical method. It communicates uncertainty in the estimated mean rather than the spread of individual observations. A narrow interval indicates greater precision than a wide interval, but precision does not determine whether a change is important in practical or clinical terms. Interpretation also depends on the outcome scale and on a justified threshold for importance, neither of which is stated beyond the circumference unit in this record.
No confidence interval, standard error, test statistic, or p-value for the circumference endpoint is reported. The registry record also does not report an inferential analysis plan. Consequently, statistical significance and precision cannot be evaluated from the posted results.
Why does the single-group design matter?
In general, a control group helps distinguish changes associated with an intervention from changes that may occur over time for other reasons. Random allocation, when used, can help make comparison groups similar on average in ways that are difficult to achieve by selection alone. This study is listed as single-group, with allocation NA, and no comparator is described. Its design therefore supports a within-group description in principle, not a randomized treatment-versus-control estimate. Masking is recorded as none; the registry does not specify which people, if any, knew the treatment status beyond that entry.
These design characteristics do not determine whether a measured change occurred. They limit what causal claims can be supported by a reported change. Since the registry does not report the change itself, the posted record does not support even a descriptive estimate of its magnitude.
How should planning illustrations be understood?
In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, significance level, allocation, and analysis method. It is not an observed outcome and does not show the probability that a completed study found a true effect. The registry’s stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as stated shares of the observed effect. It says that non-time-to-event planning values are participants per arm and that time-to-event values are total events.
Those assumptions describe a two-arm planning scenario, whereas the registered study is single-group and has no listed comparator. The assumptions are therefore not a description of the study’s observed design or its results. The record does not report a protocol-based sample-size justification, and any planning illustration should not be read as observed power or evidence that the study had a particular ability to detect an effect.
What can be inferred from the analysis entries?
The record lists 3 outcome measures and 0 analyses. This means the registry does not present statistical outcome analyses alongside the listed outcomes. It does not establish why analyses are absent, whether analyses were conducted outside the registry, or whether outcome data were collected. Those explanations are not reported in the registry record. Without the analysis results and denominators, neither the primary endpoint nor the secondary endpoints can be quantitatively interpreted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary outcome as change in circumference and names subject satisfaction and the number of participants with adverse events as secondary outcomes. It also lists 3 outcome measures and 0 analyses. No results for these outcomes are reported in the registry record, and no multiplicity procedure or hierarchy for interpreting multiple outcomes is reported.
In general, when several outcomes or statistical tests are examined, the chance of obtaining an apparently notable finding by chance can increase. A prespecified hierarchy or adjustment can help clarify how multiple results should be interpreted. The registry record does not describe such a plan, so it is not possible to determine how the listed outcomes were intended to relate to one another in confirmatory interpretation. This does not show that any particular adjustment was required or omitted; the analysis plan is not reported.
The record does not report missing-data counts, reasons for missing measurements, an approach to handling missing values, or sensitivity analyses. It also does not identify the population included in the primary endpoint analysis. The registry lists enrollment of 76, while the safety entry lists 49 at risk; it does not explain whether those figures reflect different analysis populations or why they differ. The endpoint denominator and completeness of follow-up are not reported in the registry record.
In general, missing outcome data can affect both the precision and the validity of an estimate, particularly if participants without measurements differ from those with measurements. Without information on missingness and the analysis population, the extent and direction of any such concern cannot be assessed. No statistical analysis plan, interim-analysis information, or explicit analysis-population definition is reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Radiofrequency (RF) Treatment | 0 | 49 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Radiofrequency (RF) Treatment | 3 of 49 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Radiofrequency (RF) Treatment |
|---|---|---|
| Lumps | Injury, poisoning and procedural complications | 3 of 49 |
The RF treatment safety entry lists 49 at risk, 0 serious adverse events, and 3 other adverse events. These counts are the safety information reported in the registry. They are not a comparison with another group, because no comparator is listed.
In general, a count describes the events recorded under the registry’s reporting conventions; it does not by itself describe event severity beyond the category, timing, duration, or causal relationship to treatment. The registry does not provide terms for the serious adverse events, and it does not describe the types of the other adverse events. The deaths entry is not populated, so deaths are not reported in the registry record. A blank entry should not be interpreted as a documented count of zero.
The safety denominator of 49 is not the same entry as the study enrollment of 76. The registry record does not explain the relationship between these figures, and it does not state the number included in the primary outcome analysis. The safety figures therefore should be read as the recorded safety summary, not as a complete account of all participants or as evidence about comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes what the study set out to measure: mean change in circumference from baseline to 6 months post final treatment, in centimeters. It also records a single-group RF treatment arm, enrollment of 76, and secondary outcomes concerning subject satisfaction and adverse events. The posted results include a safety entry with 0 serious adverse events and 3 other adverse events among 49 at risk in the RF treatment group.
The record does not report the primary endpoint result or analyses for the secondary outcomes. It therefore does not show whether circumference increased, decreased, or remained similar, nor how variable any change was. There is no reported estimate or uncertainty interval with which to judge precision. The information also does not establish how many participants had endpoint measurements or how missing observations were handled.
Even a reported within-group change would have limits in this design. In general, measurements before and after an intervention can describe temporal change, but without a suitable comparison group they cannot isolate the intervention’s contribution from other changes over time. Here, the registry identifies no comparator and records no masking. Thus, neither causal attribution nor a treatment-versus-control contrast is available from the registered design.
The safety counts are also limited. They do not provide a comparative risk estimate, and the registry does not report the types of other events or serious-event terms. The unpopulated deaths field does not document a zero count. The safety denominator and enrollment figure are distinct registry entries whose relationship is not explained.
These limitations do not establish that the device did or did not change circumference, satisfaction, or safety outcomes. They mean that those questions cannot be answered from the posted results. The record is most informative as a description of a terminated pilot study’s design, intended endpoints, and limited safety counts, rather than as an efficacy evaluation.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a registered research question and an interpretable estimate. The record states a continuous primary endpoint, its measurement unit, the intended follow-up time, and the summary approach. Yet it lists 0 analyses. Without an observed estimate and an uncertainty measure, readers cannot assess the magnitude, direction, or precision of the primary outcome.
The single-group design is also central to the scope of inference. In general, a before-and-after measurement can describe change in the participants studied, but it cannot by itself show what would have happened without treatment. A comparator can help address that question, and randomized allocation can support a more credible comparison by reducing systematic group differences. Neither a comparator nor random allocation is listed in this record.
The record also separates enrollment from the safety denominator: enrollment is 76, while the RF treatment safety entry lists 49 at risk. Because the relationship is not explained, readers cannot assume that the same population contributed to enrollment, safety reporting, and the primary endpoint. Clear analysis populations and outcome-specific denominators are important for understanding who contributes to each estimate.
Finally, the registry’s planning assumptions refer to equal allocation between two arms, while the study itself is registered as single-group. This is a reminder that planning scenarios should not be mistaken for observed study features or evidence of statistical power. Overall, the record demonstrates why design, outcome reporting, denominators, and uncertainty measures must be considered together before drawing statistical conclusions.
14. 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 limitations are specific to the information recorded for this trial. The registry status is terminated, but the reason for termination is not reported in the registry record. The study is described as a pilot, yet the record does not explain the pilot objectives, recruitment procedures, or whether the study was intended primarily to assess feasibility, outcomes, or both.
The intervention description identifies treatment of an abdomen, flank or thigh, but the registry does not state how body areas were selected, whether participants could contribute measurements from more than one area, or how measurements across areas were handled. Details of the circumference measurement procedure, assessor training, measurement reliability, and treatment schedule are not reported. These omissions limit interpretation of how comparable measurements might be across participants or time.
The registry records enrollment of 76 but lists 49 at risk in the safety group. It does not explain this difference. The primary endpoint analysis population, the number with baseline and follow-up measurements, and reasons for unavailable observations are not reported. The record also does not report the statistical analysis method, adjustment strategy, or handling of missing measurements.
No comparator is listed, allocation is NA, and masking is none. These design features constrain causal interpretation even if outcome estimates were available. In addition, the primary and secondary outcome analyses are absent from the registry. The record does not give satisfaction results, circumference results, or a detailed breakdown of adverse events. These are limitations of what can be interpreted from the registry record; they do not establish what may or may not have been collected outside it.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body — NCT00953160.
- Registry record last updated 2023-09-18; status last verified 2023-08.
- Results first posted 2011-03-17.
- 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.
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18. Record Summary
The registry identifies NCT00953160 as a pilot study of the Cutera RF device for reduction in size of localized areas of the body, with cellulite listed as a condition. Enrollment is recorded as 76. The design is single-group, allocation is NA, masking is none, and the study status is terminated. The start is recorded as 2009-04 and primary completion as 2010-07.
The primary outcome is mean change in circumference, in centimeters, from baseline to 6 months post final treatment, with standard deviation as the dispersion measure. Subject satisfaction and the number of participants with adverse events are listed as secondary outcomes. The registry lists 3 outcome measures and 0 analyses.
The safety entry for RF treatment lists 49 at risk, 0 serious adverse events, and 3 other adverse events. The primary endpoint result, outcome-analysis populations, missing-data handling, and explanation of the difference between enrollment and the safety denominator are not reported in the registry record. The posted results therefore do not permit assessment of the primary treatment effect.