Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes. (NCT03475992), a non-randomized na study. The primary outcome is Number of Serious Adverse Events, Directly Related to Normal Functioning of the Device.

2. Clinical Question

3. Trial Design

This completed pilot study evaluated a low-power microwave breast imaging system for screening purposes. The registry classifies the study as non-randomized, unmasked, and parallel. It lists enrollment of 25 and the sponsor as MVG Industries SAS. The study began on 2018-10-10 and reached primary completion on 2020-05-07. Its status is completed.

The intervention was the same device in each of the listed groups. The groups were organized by pre-diagnosed condition: biopsy-confirmed breast cancer, breast cyst, and biopsy-confirmed benign lesion. The cancer and benign-lesion descriptions state that core needle biopsy was performed at least 14 days before the microwave investigation. The cyst description states that there was no prior biopsy.

These condition-based groups do not form a randomized comparison. There was no separate untreated, standard-care, or alternative-imaging group in the record. Differences between the groups, if considered, would therefore not isolate an effect of the device from differences in the conditions that defined group membership. The study is best read as an exploratory device evaluation, not as a controlled test of diagnostic performance.

The stated purpose was to gather early safety information and exploratory clinical data that could guide hardware and imaging-algorithm refinement before a decision about further clinical testing. The registry describes the technology’s proposed physical basis as dielectric contrast between healthy and cancerous breast tissues at microwave frequencies. That rationale is not itself evidence that the device detected cancer accurately in this study. A protocol description, detailed statistical plan, or justification for the enrollment target is 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

Analysis population for the primary outcome, as defined in the registry: All patients who had a low-power Microwave Breast Imaging (MBI) scan completed

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.

Population: Overall, there have been twenty-five (25) patients scanned with the low-power Microwave Breast Imaging (MBI) system. Out of the twenty-five (25) patients, twenty-four (24) were included in the final analysis. The patient who was excluded from the final analysis was a patient who presented with a palpable lump which was subsequently determined to be normal breast tissue

6. Primary Endpoint

The registry lists the primary outcome as Number of Serious Adverse Events, Directly Related to Normal Functioning of the Device, measured over Through study completion, up to 21 days.

The primary endpoint counts serious adverse events directly related to normal functioning of the device. Its stated timeframe is through study completion, up to 21 days, and its population is all patients who completed a low-power Microwave Breast Imaging scan. The endpoint is a count, rather than a measure of image quality, cancer detection, or diagnostic accuracy.

A device-related serious-event count is used to describe an important aspect of early safety during clinical evaluation. In a pilot study, this kind of endpoint can flag events requiring further assessment as experience with the device accumulates. A count alone does not establish that the device is safe in all settings or for all patients. The interpretation depends on who was scanned, the observation period, the event definitions, and how completely events were captured.

The posted results list zero serious adverse events related to normal device functioning in each condition group. The registry does not report a confidence interval or a formal comparison for this endpoint. Zero observed events is a descriptive result; it does not demonstrate that the underlying risk is zero. The limited observation period and the pilot nature of the evaluation matter when interpreting the count.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation starts with the study question and design. This study’s primary endpoint is a count of serious adverse events directly related to normal functioning of the device. It is not a measure of diagnostic accuracy or a comparison of clinical outcomes between imaging strategies. The results should therefore be read as a descriptive safety account from an exploratory device evaluation.

What does a count endpoint tell the reader?

A count records how many qualifying events were observed in the endpoint population during the specified observation period. Here, the definition is limited to serious adverse events directly related to normal device functioning, and the stated period is through study completion, up to 21 days. Events outside that definition are not part of the primary count. In particular, an “other adverse event” count is a different category from the primary serious-event count.

Counts are most informative when accompanied by clear definitions of the event, the population under observation, the follow-up period, and the completeness of ascertainment. The registry identifies the scanned-patient population for the endpoint and gives group counts at risk. It does not report additional details about event adjudication, surveillance procedures, or missing outcome information in the registry record for this analysis. Those details cannot be assumed.

Why is zero not the same as no risk?

A zero count means that no qualifying event was recorded in the observed group during the stated period. It does not establish that the event is impossible or that its underlying probability is zero. General statistical reasoning: when an event is uncommon, a modest amount of observation may yield no events even when the event can occur. An uncertainty interval can help express the range of event rates compatible with observed data, but the registry record does not report such an interval for these counts.

The size and composition of the observed population also affect precision. A result from a pilot evaluation should be interpreted as early descriptive evidence, not as a precise characterization of uncommon harms across broader populations or longer exposure. The registry entries do not support a new rate calculation or uncertainty interval, so none is stated.

What does the design permit?

The study is non-randomized, unmasked, and parallel. The listed groups differ by pre-diagnosed condition, and all received the same device intervention. A randomized control group is not reported. Consequently, the group counts cannot serve as a like-for-like comparison of device exposure against no exposure or another imaging method. Descriptive differences across condition groups would not establish that diagnosis or device use caused a difference.

Randomization, when used, is a way to balance known and unknown participant characteristics between comparison groups on average. Without random allocation and a suitable comparator, causal interpretation is more limited. Masking can reduce some forms of influence on event assessment, but this study is listed as having no masking. The registry record does not report whether any separate procedures were used to limit bias in event reporting or assessment.

What can be said about planning assumptions?

The record describes a sample-size planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also describes the effect to detect as a stated fraction of the observed effect. Those are planning assumptions, not evidence about the study’s actual design or observed power. The study itself is listed as non-randomized and includes condition-based groups rather than a reported two-arm randomized comparison.

Sample-size calculations are prospective planning tools: they ask how much information a proposed design might need under specified assumptions. They do not establish how likely a completed study was to detect an effect after the results are known. The registry record does not report a trial-specific sample-size justification, the assumptions used to set enrollment, or a formal power analysis for the actual design. No sample-size illustration can replace the descriptive interpretation of the posted event counts.

What inferential results are available?

The registry entries list no analyses for the outcomes. The registry record does not report a hypothesis test, confidence interval, adjusted model, or prespecified statistical analysis plan for the primary endpoint. Without such results, the zero counts should not be described as statistically significant, as evidence of equivalence, or as proof of absence of risk. The appropriate interpretation is limited to the observed counts, their stated group sizes, endpoint definition, and timeframe.

10. Multiplicity, Missing Data and Analysis Populations

The registry record does not report how multiplicity was handled. Multiplicity arises when several outcomes, comparisons, or analyses are evaluated: looking across many tests can increase the chance of a seemingly notable result arising by chance. No analyses are listed for the outcomes in the registry record for this analysis, and no adjustment strategy or hierarchy of secondary outcomes is reported. There is therefore no basis to describe a multiplicity correction or to infer how one would have affected results.

Missing-data handling is also not reported in the registry record. The primary endpoint population is defined as all patients who completed a low-power Microwave Breast Imaging scan, but the record does not state how many enrolled participants completed scanning, whether any scans or safety assessments were incomplete, or how incomplete records were treated. The stated enrollment of 25 should not be assumed to equal the number contributing to every outcome.

The safety figures identify participants at risk within each condition group, but they do not by themselves explain the flow from enrollment to endpoint assessment. The record does not describe imputation, exclusions, censoring, or sensitivity analyses. These methods matter because missing follow-up can affect whether events are observed and counted. No claim that data were complete or that missingness had no effect is supported.

Analysis populations beyond the stated scanned-patient population are not reported in the registry record. It is not clear whether any other analysis set was defined or used. This limits assessment of consistency between the enrolled population, participants who completed scans, and those represented in the adverse-event results.

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 serious adverse-event figures refer specifically to serious events directly related to normal functioning of the device. The registry reports zero such events in the pre-diagnosed breast cancer group, zero in the breast cyst group, and zero in the pre-diagnosed benign-lesion group. The corresponding numbers at risk are 11, 9, and 5. The record also lists zero deaths in each group.

These are observed counts, not proof that the chance of a serious event is zero. The endpoint covers the stated follow-up period through study completion, up to 21 days, and only the event category defined for the primary outcome. The registry does not report a confidence interval or further detail about event assessment. The other-adverse-event count is distinct: one is listed in the breast cyst group, while zero are listed in the other groups. The record does not describe that event further in the registry record for this analysis.

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

The posted results establish that no serious adverse event directly related to normal functioning of the device was recorded in the listed groups during the stated study period. That is the central descriptive safety finding. It is relevant to an exploratory evaluation because early information about device-related events was an explicit study purpose.

The finding does not establish that the device has no serious risks. Zero observed events can coexist with uncertainty about events that are uncommon, occur after the observation period, or were not captured. The study followed participants through completion, up to 21 days, and the registry does not report a confidence interval for the endpoint. The result should therefore be interpreted within the observed population and timeframe rather than generalized beyond them.

The study also does not establish whether the device accurately detects breast cancer. The primary endpoint is a serious-event count, and no diagnostic accuracy outcome is reported in the registry record for this analysis. A proposed physical rationale for microwave imaging is not a substitute for observed performance against a reference diagnosis.

Because the study was non-randomized and had no reported control arm, it does not estimate how safety or diagnostic outcomes compare with another imaging approach or with no device exposure. The condition-based groups are not interchangeable controls. The registry record does not report an efficacy analysis, a formal inferential safety analysis, or a trial-specific sample-size justification. The evidence is best understood as early, descriptive clinical experience that can inform questions for subsequent evaluation, not as a definitive comparative conclusion.

13. Why This Trial Matters Statistically

This trial is statistically important as an example of how an exploratory device study can answer a narrower question than the technology’s intended use might suggest. Although the device was described for breast cancer screening purposes, the primary endpoint focused on serious adverse events related to normal device functioning. That distinction matters: safety counts and diagnostic-performance measures answer different questions and require different outcome definitions and analyses.

The study also illustrates the limits of interpreting groups that are defined by diagnosis rather than randomized assignment. The three condition groups all received the device, so they do not provide a control contrast. A comparison across them would mix differences in diagnosis and biopsy history with any other group differences. The design supports a descriptive account of the observed experience, not a causal estimate of device benefit or harm relative to another strategy.

Zero serious related events is useful early information, but it is not a guarantee of no risk. Statistical precision depends on the amount and duration of observation, as well as event ascertainment. The registry reports the group counts and a follow-up period through study completion, up to 21 days, but does not report an uncertainty interval or detailed missing-data accounting.

Finally, the record distinguishes the exploratory role of this study from later testing: the data were intended to inform device refinement and decisions about further clinical tests. That is a reasonable context for a pilot result. The value of the findings lies in describing what was observed and clarifying what a subsequent study would need to assess, rather than in supporting a broad claim about screening performance.

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 study is a first-in-human clinical test of the investigational device, following testing with experimental breast phantoms. Such an early evaluation provides limited clinical experience. The registry lists enrollment of 25, but the endpoint population is defined by completed scans, and the record does not report whether all enrolled participants contributed to the safety results.

There is no randomized control or alternative-imaging group. All listed groups received the device, and membership was based on pre-diagnosed breast condition. The study therefore cannot make a like-for-like comparison of the device with another approach. The absence of masking is also recorded, while further event-assessment safeguards are not reported in the registry record.

The primary outcome is limited to serious adverse events directly related to normal functioning of the device. The follow-up period is through study completion, up to 21 days. The registry does not report an uncertainty interval, detailed event-adjudication procedures, longer-term safety results, or further description of the one other adverse event listed in the cyst group. No diagnostic accuracy endpoint or efficacy analysis is reported in the registry record for this analysis.

A trial-specific sample-size justification, formal analysis plan, handling of missing data, and multiplicity approach are not reported in the registry record. These omissions limit assessment of precision and analytic choices. The results should be interpreted as an early descriptive account of the stated endpoint, not as a comprehensive safety assessment or a test of screening performance.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes. — NCT03475992.
• Registry record last updated 2021-06-07; status last verified 2021-05.
• Results first posted 2021-06-07.
• 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 describes a completed, non-randomized, unmasked, parallel pilot study of a low-power microwave breast imaging system. Enrollment is listed as 25. The study included condition-based groups with pre-diagnosed breast cancer, breast cyst, or benign lesion; the intervention in each group was the imaging device.

The primary endpoint counted serious adverse events directly related to normal functioning of the device through study completion, up to 21 days, among patients who completed a scan. The posted count was zero in each group. The record also lists one other adverse event in the breast cyst group and zero deaths in all groups.

The evaluation was intended to provide early safety information and exploratory data for device refinement. A comparator, diagnostic accuracy result, formal outcome analysis, trial-specific sample-size justification, and further details on missing data are not reported in the registry record.