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 Safety and Efficacy of Combined EMS and RF Treatments (NCT04124419), a na na study. The primary outcome is Change in Circumference Reduction.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04124419 |
| Phase | NA |
| Condition | Non-invasive Circumference Reduction |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | InMode MD Ltd. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns eligible subjects enrolled in a trial for non-invasive circumference reduction. The registry record gives an enrollment of 20, but does not describe the full eligibility criteria or the characteristics of participants who received treatment. The adverse-event record lists a treatment-arm population at risk of 17; why this differs from the enrollment figure is not reported in the registry record.
Intervention
Participants in the treatment arm were to receive up to 3 treatments with the Evolve device using the Ti10 and Tone applicators. Treatments were scheduled at a 2-week interval according to the study protocol. The stated aims were abdominal non-invasive circumference reduction and skin tightening. The registry record does not report how many treatments each participant actually received.
Comparator
There is no separate comparator group in the registered design. The study is classified as single-group, and allocation is listed as NA. Baseline measurements are part of the primary endpoint, but a baseline measurement is not a concurrent control group. Therefore, the design does not provide a like-for-like comparison with an untreated or alternative-treatment group.
Primary question
The primary question is how abdominal circumference changed from baseline to 6 months following the last treatment session. Circumference was measured with a standard measuring tape, and the planned summary was the median change with the full range. Negative values indicate a reduction. The registry record does not report the observed median, range, or an analysis of this endpoint, so the magnitude and precision of the observed change cannot be assessed from the record.
3. Trial Design
The registry record describes a completed, single-group device study, with enrollment of 20 and no randomized allocation. Its title calls it a baseline controlled study, but the registered design does not include a separate concurrent control group. Baseline provides a reference measurement for change over time; it does not control for changes that might occur for other reasons during follow-up. The record lists masking as none and phase as NA.
The intervention was treatment with the Evolve System. Eligible subjects were to receive up to 3 sessions using the Ti10 and Tone applicators, with a 2-week interval, according to the protocol. The record does not state how many sessions were received by each participant, whether all participants completed follow-up, or what adjustments were made when treatment schedules differed.
The registered primary endpoint was change in circumference, measured in centimeters, from baseline to 6 months following the last treatment session. The primary summary was the median and full range. Secondary outcomes included investigator assessment of abdomen area appearance, subject improvement assessment, and subject satisfaction assessment. The record reports four outcome measures and zero analyses.
The study status is completed. The start date is 2019-07-19 and the primary completion date is 2021-05-19. The sponsor is InMode MD Ltd. Although completion indicates that the registered study has concluded, it does not itself establish that endpoint results were reported. The registry record does not report the observed primary outcome, the secondary outcome findings, or an inferential analysis. The design can describe change in the treated group over time, but without a concurrent comparator it cannot separate treatment-associated change from other influences.
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 | Treatment Arm |
|---|---|
| STARTED | 20 |
| COMPLETED | 17 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Treatment Arm |
|---|---|
| Lost to Follow-up | 3 |
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 | Treatment |
|---|---|---|
| Participants analysed | 17 | |
| Age, Customized: Age | years | 38.158 (SD 9.63) |
| Sex: Female, Male: Female | Participants | 16 |
| Sex: Female, Male: Male | Participants | 1 |
| Race and Ethnicity Not Collected | Participants | — |
| Fitzpatrick Skin Type: Type I | Participants | 1 |
| Fitzpatrick Skin Type: Type II | Participants | 5 |
| Fitzpatrick Skin Type: Type III | Participants | 4 |
| Fitzpatrick Skin Type: Type IV | Participants | 5 |
| Fitzpatrick Skin Type: Type V | Participants | 2 |
| Fitzpatrick Skin Type: Type VI | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Circumference Reduction, measured over Baseline to 6 months following last treatment session.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | centimeters (cm) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the change in abdominal circumference from baseline to 6 months following the last treatment session. Circumference was measured in centimeters with a standard measuring tape. The endpoint uses a change from baseline so that each participant’s follow-up measurement is interpreted relative to their own baseline rather than as a follow-up value alone. The registry definition states that negative values indicate a reduction in circumference.
The planned summary is the median change and full range. The median describes the middle of the observed changes when they are ordered, while the full range describes the smallest and largest values. This choice can be useful when a distribution is skewed or includes unusually large changes, since the median is less influenced by extreme values than the mean. The range also makes the spread visible, although it is sensitive to the most extreme observations and does not show how densely values cluster between the endpoints.
The endpoint targets a physical measure aligned with the stated aim of circumference reduction. It does not, on its own, measure skin tightening, satisfaction, or perceived improvement; those are addressed by separate registered secondary outcomes. The registry record does not report the observed median change, full range, or participant-level measurements. It also does not report details such as measurement reliability, assessor masking, or how missing circumference measurements were handled. Consequently, the endpoint’s definition is available, but its observed magnitude and precision are not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available registry information describes a completed study and its intended assessments, but does not give the primary endpoint result. In particular, there is no reported median change in circumference or full range from baseline to 6 months following the last treatment session. Without those values, the direction, size, and variability of the observed circumference changes cannot be evaluated. The fact that negative values were defined as reductions explains how a reported result would be read; it does not establish that a reduction was observed.
The registry record reports zero analyses. It therefore does not provide an inferential result for the primary endpoint, such as a confidence interval or a p-value. A confidence interval, in general, expresses uncertainty around an estimated effect under the assumptions of the analysis. Here, no primary estimate or interval is reported, so statistical precision cannot be assessed. The record also does not report the secondary outcome findings for investigator assessment of abdomen area appearance, subject improvement, or subject satisfaction.
Interpretation is also constrained by the single-group design. The study compares follow-up with baseline within the treated group rather than comparing treated participants with a concurrent control group. A before-and-after change can reflect the intervention, but can also reflect other influences over time, measurement variability, or changes in who contributes measurements at follow-up. The record does not describe methods that would separate these possibilities. The title’s reference to baseline control does not change the registered classification as single-group.
The enrollment figure is 20, while the adverse-event record lists 17 subjects at risk in the treatment arm. These figures describe different registry entries; the reason for the difference is not reported in the registry record. The adverse-event counts should therefore be read using their stated at-risk population, not treated as a report of the primary endpoint population.
Overall, the registry record establishes the study’s purpose, intervention, endpoint definition, and some safety counts. It does not establish the size or precision of any observed efficacy-related change, and it does not permit a comparison with no treatment or another treatment. The absence of a reported result is not evidence that there was no change, nor is it evidence that there was a change. Conclusions about the primary endpoint require results that are not reported in the registry record.
9. Statistical Methods Explained
The primary outcome was defined as change in circumference from baseline to 6 months following the last treatment session. A change score places the follow-up measurement in relation to baseline, so its interpretation depends on the registered direction convention: negative values indicate a reduction. The measurement unit is centimeters, and the stated instrument is a standard measuring tape. The record does not provide the actual change values or the number of participants with measurements at both time points.
Why use the median and full range?
The registry specifies the median as the summary measure and the full range as the measure of dispersion. In general, the median is the central observation after values have been ordered. It is often useful when measurements are asymmetric or when extreme observations could pull a mean away from the typical value. The full range gives the lowest and highest observations, making the breadth of the data visible. It does not describe the distribution between those endpoints, and it can be strongly influenced by extreme observations. No median or range is reported for this endpoint, so these features describe the planned summary rather than an observed result.
What does the design allow?
The registered model is single-group, with no randomized allocation and no masking. The primary comparison is over time within the treated group: baseline versus follow-up. In general, a within-group change describes what happened over the observation period among those measured. Without a concurrent comparison group, it does not isolate what would have happened over the same period without the intervention. Changes in behavior, natural variation, measurement conditions, or loss to follow-up can also contribute to an observed before-and-after difference. The registry record does not report an analysis intended to address these factors.
What would an uncertainty estimate convey?
In general, a confidence interval describes a range of values compatible with the data and statistical model, and communicates uncertainty in an estimate. A p-value addresses how compatible the observed data are with a specified null model; it is not a measure of effect size or clinical importance. Neither a confidence interval nor a p-value for the primary endpoint is reported in the registry record. With no reported estimate, these concepts cannot be applied to quantify this study’s primary finding.
What is reported about analysis planning?
The registry record reports zero analyses. It does not report an analysis plan, a sample-size justification, interim analyses, or a model for the primary outcome. It also does not report an adjustment for covariates, a strategy for repeated measurements, or how departures from the planned treatment schedule were handled. Those details should not be inferred from the endpoint definition or from the study’s completed status.
A sample-size planning illustration is distinct from an observed study result. The stated assumptions describe two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such an illustration is not the trial’s own design justification and is not observed power. It also does not change the single-group structure of this study. The registry record does not report the observed primary effect needed to interpret an illustration in relation to this study’s endpoint.
The endpoint’s use of a median and range is descriptive. It can convey a typical observed change and the extremes, but it does not by itself provide a controlled treatment effect or a formal estimate of uncertainty. Because the registry record does not report the endpoint values, no recalculation from summary statistics is possible. No independent recalculated result should be substituted for a sponsor analysis; in any event, no sponsor analysis is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary circumference-change outcome and three secondary outcomes: investigator assessment of abdomen area appearance, subject improvement assessment, and subject satisfaction assessment. It reports four outcome measures and zero analyses. The record does not report whether the outcomes were analyzed, how they were ordered for interpretation, or whether a multiplicity adjustment was planned or used.
In general, testing several outcomes can increase the chance of finding an apparently notable result by chance if each is assessed separately. Multiplicity procedures can account for that issue, but they can also affect how results are interpreted. No procedure or outcome hierarchy is reported in the registry record, so the role of multiplicity in any conclusions cannot be assessed. The absence of reported analyses also means that no reported result can be compared across the registered outcomes.
The analysis population is not specified in the primary outcome description. The record does not report whether analyses included all enrolled participants, only participants who received treatment, or only those with complete follow-up. It does not describe missing-data handling, reasons for missing measurements, or whether any participants discontinued treatment or follow-up. Those details matter because an endpoint measured after treatment can be affected by incomplete follow-up and by differences between those with and without observed measurements.
Enrollment is reported as 20, while the adverse-event entry lists 17 subjects at risk. The relationship between these registry figures, including any exclusions or missing data, is not reported in the registry record. They should not be treated as interchangeable denominators. In the absence of an analysis population definition and missing-data information, the representativeness of any endpoint result cannot be assessed; moreover, the endpoint result itself is not reported.
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 |
|---|---|---|---|
| Treatment Arm | 0 | 17 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment Arm | 0 of 17 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment Arm | 0 of 17 |
The adverse-event entry lists a treatment-arm population at risk of 17. It reports 0 subjects with serious adverse events, 0 with other adverse events, and 0 deaths. No serious adverse-event terms are listed. These are registry counts for the population stated in that entry; the record does not explain why the at-risk population differs from the enrollment of 20.
Zero reported events in these categories means that the registry entry records no affected subjects in the listed population. It does not establish that the device has no risk, or that every possible adverse event was identified and reported. Safety counts are interpreted in light of how events were defined, collected, monitored, and attributed. The registry record does not report those details, nor does it provide a description of the observation period for adverse events.
The safety counts are separate from the primary circumference endpoint. They do not indicate whether circumference changed, and they do not provide evidence about the secondary appearance or satisfaction outcomes. The absence of listed serious-event terms should be read alongside the zero serious-event count, not as a detailed account of all safety monitoring or non-serious symptoms.
12. What the Result Does, and Does Not, Mean
The registry record describes a study designed to assess abdominal circumference change and other appearance-related outcomes after treatment with the Evolve System. It also reports adverse-event counts for the treatment arm. These details establish what the study set out to examine and provide limited information about recorded safety events.
The record does not report the observed median circumference change or its full range. It does not report findings for investigator assessment of abdomen area appearance, subject improvement, or subject satisfaction. Therefore, the record does not show the magnitude, direction, or precision of the primary outcome, and it does not show whether the secondary outcomes changed. Completion of the study is not a substitute for reporting those results.
The study is single-group, with no randomized allocation and no masking. A measured change between baseline and follow-up, if reported, would describe change over time among the participants measured. It would not, by itself, identify how much of that change was attributable to the treatment rather than other influences. The registry record does not provide a concurrent control group or an analysis that resolves that limitation.
The reported safety counts are 0 serious adverse events, 0 other adverse events, and 0 deaths among 17 subjects at risk. These counts describe what is recorded for that group and do not establish that risk is absent. The registry does not explain the difference between the adverse-event at-risk population and the enrollment figure of 20.
Thus, the record supports a description of the registered design, endpoint definitions, and safety counts, but not a conclusion about the observed efficacy-related outcomes. It cannot establish that circumference was reduced, that skin tightening occurred, or that treatment caused any change. It also cannot support a comparison with an untreated group or another intervention. The missing outcome findings and analysis details are central to interpreting the study’s clinical and statistical meaning.
13. Why This Trial Matters Statistically
This study illustrates the distinction between a clearly defined endpoint and a reported endpoint result. The registry specifies the measurement, unit, direction convention, summary measure, and follow-up time for circumference change. Those details help define what an analysis would need to address. However, without the observed median and full range, readers cannot assess even the descriptive outcome, much less its uncertainty.
The single-group structure is also statistically important. Measuring change from baseline is informative about the course of measurements among treated participants, but it does not create a concurrent control. A baseline comparison cannot account for every factor that may change over time. This distinction matters when interpreting claims about cause: an observed before-and-after pattern would not alone establish that the intervention produced it.
The registry record also demonstrates why denominators and analysis populations matter. Enrollment is listed as 20, whereas the safety entry lists 17 subjects at risk. Without an explanation of that difference, readers cannot assume that the safety count and the primary endpoint would use the same population. The record does not identify the endpoint analysis population or describe missing-data handling.
Finally, a completed status and a detailed endpoint definition do not replace findings. The record lists secondary outcomes and safety counts, but reports zero analyses and no primary outcome estimate. Statistical interpretation depends not just on the planned question but on the observed data, the analysis population, and the methods used. Those elements are not reported for the primary endpoint, leaving the study’s outcome magnitude and precision unresolved in the registry record.
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 most immediate limitation for interpretation is that the registry record does not report the primary circumference-change result. No median or full range is available, and no inferential analysis is reported. The registered secondary outcomes are named, but their results are not reported either. Consequently, the study’s outcome magnitude and precision cannot be assessed from this record.
The study is single-group and has no randomized allocation or masking. Baseline measurement offers a within-participant reference, but there is no concurrent comparator to help separate treatment-associated change from other influences over time. This design limitation applies even if endpoint values were available. The registry record does not describe methods that would address confounding or measurement bias.
The record does not report the analysis population, the number with endpoint measurements, whether participants completed the planned treatment schedule, or how missing data were handled. The enrollment figure of 20 and the safety population at risk of 17 are not explained in relation to each other. The record also does not provide participant characteristics or detail the eligibility criteria, which limits assessment of how broadly findings might apply.
Measurement details are limited to use of a standard measuring tape. The registry record does not report assessor procedures, measurement reliability, or whether measurements were made under standardized conditions. It also does not describe adverse-event definitions, collection methods, or monitoring duration. These omissions constrain interpretation of both the circumference endpoint and the safety counts.
Finally, the record does not report an analysis plan, multiplicity approach, sample-size justification, or interim analyses. Without these details, the intended statistical framework cannot be fully evaluated. These limitations are specific to the information recorded and do not establish that a procedure was or was not used outside the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of Combined EMS and RF Treatments — NCT04124419.
- Registry record last updated 2026-02-27; status last verified 2026-02.
- Results first posted 2026-02-27.
- 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
NCT04124419 is a completed, single-group device study sponsored by InMode MD Ltd. The registered intervention is treatment with the Evolve System using the Ti10 and Tone applicators, with up to 3 treatments at a 2-week interval. The primary outcome is median change in circumference, with full range, from baseline to 6 months following the last treatment session; negative values indicate reduction.
The record lists enrollment of 20, three secondary outcomes, four outcome measures, and zero analyses. It does not report the primary circumference result or the secondary outcome findings. The adverse-event entry lists 17 subjects at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. The reason for the difference between enrollment and the safety population is not reported in the registry record.
The single-group design has no concurrent comparator, and the record does not specify an analysis population or missing-data approach. Thus, the registered objective and endpoint are clear, but the outcome magnitude, precision, and causal interpretation remain unavailable from the registry record.