Multi-Center Pivotal Study of Radiofrequency Device: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Multi-Center Pivotal Study of Radiofrequency Device (NCT04569253), a na na study. The primary outcome is % of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline.

2. Clinical Question

The clinical question was whether photographs taken before treatment could be distinguished from follow-up photographs after radiofrequency treatment on the flank, using blinded evaluation. The untreated flank was intended to provide a control within each participant. However, the endpoint description hinges on a comparison of baseline and follow-up photographs, and the registry states that the subject who attended the 12-week visit did not have photographs taken for this outcome. The record therefore contains no usable primary-outcome result with which to answer the question. It also does not report a formal statistical comparison between treated and untreated flanks.

3. Trial Design

The registry describes a prospective, controlled, multi-center study of the TempSure radiofrequency device. Its brief summary says that patients with unwanted flank fat would be enrolled and treated. The study is marked completed, with a recorded enrollment of 65. Its start date is 2020-07-28 and its primary completion date is 2021-03-26. The phase is listed as NA.

The intervention arrangement assigned treatment to one flank and left the other flank untreated as a control. The registry describes all study participants as receiving device treatment on one flank. This makes the control a body-side comparator within participants rather than a separate untreated group of people. The allocation field is NA, and the record explicitly cautions that the arms are not a randomized, like-for-like control comparison. It does not report how the treated side was selected or whether side assignment followed a prespecified procedure.

Masking is listed as NONE. Separately, the primary endpoint description says that blinded evaluators were to identify pre-treatment images versus images from the 12-week follow-up. These statements refer to different aspects of study conduct: the masking field describes the trial classification, while the endpoint description specifies that evaluators assessing photographs were blinded. The registry does not explain the blinding procedures or identify who was masked to what information.

The primary endpoint is a photographic assessment at the 12-week follow-up. The record says 1 subject attended that visit and was considered complete, but no photographs were taken for this outcome. It reports no analysis for the primary endpoint. Further details about treatment frequency, follow-up procedures, the number of centers, eligibility criteria, allocation procedures, and the statistical analysis plan are not reported in the registry record. The record also gives no rationale for the enrollment target.

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

Analysis population for the primary outcome, as defined in the registry: 1 subject attended the 12 week follow up so was considered complete, but did not have pictures taken for this outcome measure.

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 % of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline, measured over 12 Week Follow Up.

The primary endpoint is titled “% of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline.” It measures the percentage of photographs that blinded evaluators correctly classified as pre-treatment or follow-up images. In principle, this is an image-based assessment of whether visual appearance differs between baseline and the 12-week follow-up after treatment. It is not a direct measurement of fat volume or a participant-reported assessment.

Photographic evaluation can provide a structured way to assess visible change, particularly when evaluators do not know the image time point. Blinding is intended to reduce the influence of expectations on image classification. As a general statistical matter, however, the interpretation depends on how images are selected, how many are assessed, what counts as a correct identification, and how evaluator judgments are combined. Those operational details are not reported in the registry record.

The record says that 1 subject attended the follow-up and was considered complete, but did not have photographs taken for this outcome. It does not report an endpoint value, the number of photographs evaluated, or the number identified correctly. Therefore, although the endpoint is defined, the posted record does not contain the observations needed to estimate it. Without an evaluable endpoint result, the degree of photographic change cannot be quantified from this registry entry.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as a number-type outcome expressed as the percentage of photographs identified correctly. The intended assessment compares baseline photographs with photographs from the 12-week follow-up. Blinded evaluators were to classify the images. No statistical analysis is listed, and the record contains no numerical result for this endpoint.

What would an endpoint estimate represent?

In general, a percentage of correctly classified photographs describes the proportion of evaluated images for which the classification was correct under the study’s scoring rule. It is an estimate based on the photographs that were actually available and assessed. Its interpretation depends on the image set, the evaluator process, and the rule used to define correctness. The registry does not report those details or the number of photographs evaluated, so the endpoint cannot be reconstructed from the entry.

A confidence interval, in general, expresses the uncertainty around an estimate under a specified statistical model and sampling process. It does not describe every possible source of bias, and it cannot be calculated meaningfully without an endpoint estimate and relevant information about the observations. No confidence interval is reported for the primary outcome. The record’s missing photographs for the follow-up attendee mean that there is no posted endpoint estimate whose precision can be assessed.

Why does the within-participant structure matter?

The planned treatment arrangement places a treated flank and an untreated flank within the same participant. As a general statistical principle, measurements from the same person tend to share characteristics and may be correlated. A comparison that treats them as independent can misstate uncertainty. An analysis designed for paired or otherwise linked observations can account for this relationship, but the registry does not report what analysis, if any, was planned or performed.

The endpoint is described as a comparison of baseline and follow-up photographs, rather than a clearly specified numerical contrast between the treated and untreated flanks. The registry does not explain whether photographs were assessed separately by side, whether evaluators made paired judgments, or how those judgments would be summarized. It also does not report a model, test, standard error, confidence interval, or hypothesis test. No particular statistical method should therefore be attributed to the study based on this record.

The allocation field is NA, and the record cautions that this was not a randomized comparison. Randomization, as a general design principle, can help balance prognostic factors across comparison groups. In a within-participant design, random assignment of the treated side can also help prevent systematic side selection from influencing the contrast. The registry does not report whether the treated flank was selected randomly or by another method. That uncertainty limits the strength of causal interpretation even if an outcome estimate were available.

What does the safety count measure?

The registry presents people affected by serious and other adverse events, with participants at risk listed separately for the RF Device and Control groups. It records 0 serious adverse events in each group and 0 deaths in each group. For other adverse events, it records 10 affected in the RF Device group and 0 in the Control group. These are registry counts; the record does not describe the events, their severity, timing, duration, or relationship to treatment.

As a general matter, a count alone does not convey all the information needed to compare safety. Interpretation may depend on follow-up completeness, exposure time, event definitions, repeated events in one person, and whether events were actively collected. The entry does not provide those details. It also does not report an inferential comparison of adverse-event outcomes. The counts should therefore be read descriptively, not as a formal estimate of relative safety.

How should planning calculations be understood?

The planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are described as planning assumptions, not as the study’s own design specification. The record does not report a primary-outcome effect estimate, and no analysis is listed. Any planning illustration associated with this record cannot fill that evidence gap and must not be described as observed power. It is not evidence that the trial had a particular probability of detecting an effect.

More generally, sample-size planning depends on a target effect, variability or event assumptions, the desired error rates, and the planned analysis. A planning estimate describes what a hypothetical design might require under stated assumptions; it does not establish what was observed in a completed study. The registry does not report the rationale for enrollment of 65, or a trial-specific sample-size justification. The listed assumptions should not be treated as proof that the study was planned or analyzed according to those assumptions.

Because the primary result and analysis are absent, statistical concepts such as effect magnitude, precision, significance, and model fit cannot be applied to an efficacy finding from this record. The appropriate reading is that the outcome was defined, but the posted registry entry does not report an analyzable result.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure and zero analyses. It does not report a statistical analysis plan, a testing hierarchy, adjustment for multiple comparisons, or interim analyses. Whether additional outcomes were prespecified or assessed is not established by this entry. Without a reported analysis plan or results, it is not possible to determine how multiplicity was handled or whether selective reporting influenced which findings appear in the record.

Missingness is central to the primary endpoint. The registry states that 1 subject attended the 12-week follow-up and was considered complete, but had no photographs taken for the endpoint. Attendance at follow-up does not make the photographic measurement available. The record does not state why the photographs were not taken, whether other subjects had follow-up photographs, or whether missing outcome data were addressed using any method.

In general, missing-data methods rely on assumptions about why measurements are absent and how the missing observations relate to observed information. Those assumptions cannot be assessed when the reason for missing photographs and the broader pattern of missingness are not reported. No imputation, sensitivity analysis, or alternative analysis population is described. The entry also does not define an intention-to-treat, per-protocol, or other analysis population for the primary endpoint.

These omissions prevent assessment of whether the intended endpoint analysis was robust to missing data or multiplicity. They also mean that the registry’s completion status should not be taken to imply that a primary efficacy analysis was completed: the entry lists no analyses and no primary result.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists adverse-event counts separately for the RF Device and Control groups. For serious adverse events, it records 0 affected in the RF Device group and 0 in the Control group. It also records 0 deaths in each group. The registry lists 65 at risk in each group for these serious-event entries. For other adverse events, it records 10 affected in the RF Device group and 0 in the Control group, with 65 at risk listed for each.

These are descriptive registry figures, not a complete safety analysis. The record does not identify the other adverse events, report their severity or timing, explain how events were collected, or state whether any were judged related to the device. The counts also do not supply information about event duration or repeated events. The untreated control flank is not a randomized, like-for-like control comparison according to the registry, so differences in these counts should not be interpreted as a randomized treatment effect.

Zero recorded serious events and deaths means that none are listed in these registry entries; it does not establish that an intervention has no risk. The counts should be read within the limits of the information recorded and not as evidence about unreported events or unmeasured safety outcomes.

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

The record describes a prospective, multi-center study in which the TempSure radiofrequency device was used on one flank and the other flank was left untreated. It defines a primary photographic endpoint intended to assess whether blinded evaluators could correctly identify baseline versus 12-week follow-up images. It also reports adverse-event counts for the RF Device and Control groups.

What the record does not provide is the primary endpoint result. It says that 1 subject attended the follow-up and was considered complete, but that no photographs were taken for the outcome. It lists zero analyses. As a result, the record cannot quantify the photographic classification outcome, estimate its uncertainty, or establish a difference between treated and untreated flanks. Absence of an outcome result is not a finding of no effect, and the planned endpoint definition is not evidence of an effect.

The safety entries show 0 serious adverse events and 0 deaths listed for each group, and 10 people affected by other adverse events in the RF Device group compared with 0 in the Control group. They are descriptive counts. The record does not provide the types of other events or enough detail to interpret their timing, severity, or attribution. The nonrandomized, within-participant comparison also should not be treated as equivalent to a randomized comparison.

Thus, the registry entry documents study design features and some safety information, but it does not provide the analyzable efficacy result needed to answer the primary clinical question. Conclusions about the size, precision, or statistical significance of an efficacy effect are not supported by the posted results. The registry record is also not a substitute for a fuller report of outcome collection and analysis.

13. Why This Trial Matters Statistically

This trial is statistically notable because its central outcome depends on photographs, yet the registry reports that the follow-up attendee did not have photographs taken for that outcome. The endpoint is defined, but the record lists no result and zero analyses. This illustrates why a stated outcome and a completed study are not enough to establish that a question has been answered: the measurement itself must be available, analyzed, and reported.

The design also raises an important issue about dependence. Treatment and control were assigned to opposite flanks of the same participant, so observations from the two sides are linked. In general, that arrangement can support an efficient within-participant comparison when outcomes are measured consistently and the analysis accounts for the pairing. Here, however, the registry does not report a formal comparison, and it cautions that the arrangement is not randomized or like-for-like. The intended design cannot be evaluated as a statistical contrast without information about side assignment and analysis.

Blinded evaluation is relevant because image classification can be influenced by expectations. The endpoint description states that evaluators were blinded, but the masking field is NONE and procedural details are not given. The distinction underscores the need to report what was blinded and how that was implemented rather than relying on a general masking label alone.

Finally, the safety counts show why descriptive numbers need context. The registry records counts of affected people, but not event descriptions or the details needed for fuller assessment. Taken together, the entry demonstrates that sound interpretation depends not only on design and statistical methods, but also on complete outcome collection and transparent reporting.

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.

The principal limitation is that the registry does not report an analyzable primary outcome. The endpoint is based on identifying baseline and 12-week follow-up photographs, yet the record says the subject who attended follow-up had no photographs taken for this measure. No endpoint estimate or analysis is listed. The result is an evidence gap, not a negative efficacy finding.

Other aspects of outcome collection are unclear. The number of photographs assessed, the image-selection procedure, the scoring rule, and the way evaluator judgments would be combined are not reported. The record does not explain why the photographs were unavailable or describe missing-data handling. It also does not state whether the endpoint was assessed for any other participants.

The within-participant control arrangement is not randomized according to the record, and the treated-side selection procedure is not reported. Although each participant had one treated flank and one untreated flank, the registry cautions that this is not a like-for-like randomized comparison. Without side-assignment details and an analysis accounting for the linked flanks, the intended control contrast cannot be fully assessed.

The registry’s masking field is NONE, while its endpoint description says evaluators were blinded. It does not clarify the scope or conduct of evaluator blinding. The adverse-event entries lack event names, timing, severity, and attribution. The record also does not report the statistical analysis plan, sample-size justification, interim analyses, or defined analysis populations. These limitations leave substantial uncertainty about how outcomes were collected, analyzed, and interpreted.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Multi-Center Pivotal Study of Radiofrequency Device — NCT04569253.
• Registry record last updated 2022-06-14; status last verified 2022-06.
• Results first posted 2022-06-14.
• 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.

18. Record Summary

The registry record for NCT04569253 describes a completed, prospective, controlled, multi-center study of the TempSure radiofrequency device for flank fat. Enrollment is listed as 65. Participants received treatment on one flank, with the other flank left untreated as a control. The registry cautions that the comparison was not randomized and was not a like-for-like control comparison.

The primary endpoint was the percentage of photographs correctly identified when comparing baseline with the 12-week follow-up by blinded evaluators. The record says that 1 subject attended that follow-up but had no photographs taken for the endpoint. It lists zero analyses and no primary-outcome result. Safety listings record 0 serious adverse events and 0 deaths in both groups; other adverse events are listed for 10 affected in the RF Device group and 0 in the Control group. Event details are not reported.