Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (NCT04267562), a na na study. The primary outcome is Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75).

2. Clinical Question

This question concerns a measured bleeding outcome after a single procedure, not a comparison between assigned treatment strategies. The trial also listed secondary outcomes concerning subsequent medical or surgical intervention for abnormal bleeding, amenorrhea, and dysmenorrhea-related pain. Their presence in the registry does not establish what those outcomes were or whether results were reported for them. The study title and condition descriptions identify menorrhagia and heavy menstrual bleeding as the clinical context; the primary endpoint operationalizes bleeding change through a patient-completed scoring system.

3. Trial Design

The EASE Clinical Trial was a prospective, multicenter, single-arm, open-label, non-randomized clinical trial evaluating the Minitouch Endometrial Ablation System in premenopausal women with menorrhagia. The registry lists the study as completed, with enrollment of 219. The recorded start date is 2020-02-28 and the primary completion date is 2022-07-20. The phase is listed as NA.

Participants in the single arm were to undergo a single endometrial ablation treatment with the Minitouch System. There was no separately assigned control group, and allocation is listed as NA. Masking is listed as NONE. These features mean that the study describes outcomes within a treated group; they do not create a randomized comparison that can isolate treatment effects from other influences on outcomes over time.

The primary endpoint was assessed at Month 12 post-procedure. Its stated population is the Intent-to-Treat Analysis Cohort, defined in the record as all subjects who met all trial eligibility criteria and in whom the procedure was initiated. This definition is more specific than the overall enrollment figure. The number meeting that definition, and the number with an available Month 12 endpoint assessment, are not reported in the registry record.

The registry lists 27 outcome measures and 0 analyses. The number of listed measures alone does not indicate how many were analyzed or reported. The record does not describe the protocol’s sample-size justification, a statistical analysis plan, interim analyses, or procedures for handling missing endpoint data. Those design details should not be inferred from the prospective or completed status of the study.

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.

Before assignment: A total of 219 subjects were screened for the Trial, and 114 subjects were considered treated-enrolled. The remaining 105 subjects were excluded prior to treatment assignment for the following reasons: 1. Trial enrollment reached: 21.9% (23/105) 2. Withdrawn consent: 8.6% (9/105) 3. Site closure: 5.7% (6/105) 4. Lost to follow-up: 1.9% (2/105) 5. Physician decision: 1.0% (1/105) 6. Screen failure (met one or more exclusion criterion(ia)): 61.0% (64/105)

Assessed for Eligibility

Reasons for not completing this period:

Treated-Enrolled

24-Hour Contact

Week 2

Analysis population for the primary outcome, as defined in the registry: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.

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: Baseline demographics and characteristics reported for ITT Analysis Cohort.

6. Primary Endpoint

The registry lists the primary outcome as Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75), measured over Month 12 post-procedure.

The primary endpoint counts participants with a reduction in menstrual bleeding, defined as a PBLAC score of ≤75 at Month 12 post-procedure. PBLAC, or the Pictorial Blood Loss Assessment Chart, is described in the registry as a validated, patient self-reported menstrual diary scoring system. Participants record menstrual bleeding, and the resulting score provides a structured measure for assessing change in bleeding.

The registry describes the scale as having a minimum of 0, indicating amenorrhea, and no stated maximum. A score of 100 indicates eumenorrhea, or normal menstrual bleeding. Lower scores indicate less bleeding and higher scores indicate more bleeding. The success threshold of ≤75 therefore defines a binary endpoint: each participant either meets the threshold or does not meet it, according to the recorded PBLAC score.

A threshold-based endpoint can make a clinical outcome easier to summarize as a count of participants meeting a prespecified definition. It also simplifies a range of scores into two categories, so it does not show how far a participant’s score lies above or below the threshold. The endpoint’s Month 12 timing specifies when the assessment is intended to represent bleeding status. The number meeting the threshold, the analyzed denominator, and any uncertainty estimate for this result are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

In general, a single-group trial measures outcomes in participants receiving a study intervention without assigning a separate group to a comparator. The EASE Clinical Trial is described as single-arm and non-randomized, with open-label treatment. These terms distinguish the design from a randomized controlled trial: there is no randomized allocation between treatment strategies, and the study does not contain a like-for-like control arm. The registry lists allocation as NA and masking as NONE.

What does the primary endpoint count?

The primary endpoint is binary at the participant level. A participant is counted as meeting the registry’s definition of success if the Month 12 PBLAC score is ≤75; otherwise, that participant does not meet this threshold. Binary outcomes can be summarized by the number of participants in each category and, when the denominator is known, by the fraction meeting the criterion. The registry record does not report the endpoint count or analysis denominator, so neither a fraction nor an uncertainty estimate can be stated from the record.

The PBLAC score itself is a scale, while the primary outcome turns that score into a threshold-based classification. This makes the endpoint clinically interpretable as a count meeting a defined bleeding criterion, but it discards detail about the exact score. Two participants on the same side of the threshold may have different scores, and a small score change near the threshold may alter the classification while a larger change elsewhere on the scale may not. Those are general properties of threshold endpoints, not claims about the trial’s participants.

Why is a confidence interval useful?

In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the analysis. For a binary endpoint, an interval around the fraction meeting the threshold can help show how precisely the result is estimated. Its width depends in part on the number of observations and the observed outcome distribution, as well as the method used. The registry record does not report a primary endpoint estimate or confidence interval, so the precision of the trial’s primary result cannot be assessed from the record.

A p-value, when reported, addresses the compatibility of data with a stated statistical model or null hypothesis. It does not measure the size or clinical importance of an effect, and it cannot replace an estimate with an uncertainty interval. No primary analysis or p-value is reported in the registry record. The absence of a posted analysis means there is no basis in the record for describing statistical significance.

What can a single-group estimate establish?

In general, a treated-group outcome can describe what was observed among the analyzed participants. A comparison of outcomes before and after treatment may also describe change if both measurements and their analysis are reported. But a within-group change is not equivalent to a randomized treatment contrast. Without a separate comparison group, the observed outcome cannot isolate the effect of the intervention from changes that might occur over time, differences in participant characteristics, or other influences. The registry record does not report a before-and-after estimate for this endpoint.

Randomization is commonly used to balance measured and unmeasured characteristics between comparison groups, on average. Because this trial is non-randomized and single-arm, that design-based protection is not available for a treatment contrast. This does not invalidate descriptive reporting of the group; it limits the causal interpretation that can be drawn from such a design. No causal effect estimate is reported in the registry record.

How should planning calculations be read?

In general, a sample-size calculation is a planning exercise based on assumptions about the outcome, the effect to detect, the significance level, allocation, and statistical method. The registry describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of an observed effect. These are assumptions for the planning illustration, not a description of the actual single-arm trial’s design or proof of its original sample-size rationale. The registry record does not report the protocol’s sample-size justification.

Planning figures based on an observed effect are conditional on that effect and on the stated assumptions. They should be understood as hypothetical planning illustrations, not as the number actually required by the trial protocol and not as observed power. In general, observed power is not a substitute for interpreting an estimate and its uncertainty. The underlying primary endpoint result is not reported in the registry record, so its size and precision cannot be independently.

In general, over-dispersion matters when the variability in data exceeds what a chosen statistical model assumes. For a simple binary count, the relevant model and its assumptions should match the design and outcome; other outcome types can require models that explicitly allow extra variation. The primary endpoint is described as a participant count, but the registry record gives no analysis method, model, or diagnostic information. It would therefore be inappropriate to assert that over-dispersion was present, that a particular model was used, or that it changed the result.

Finally, analysis populations and missing observations affect interpretation. An endpoint count needs a clearly defined denominator, and missing assessments can reduce the information available or create bias if missingness is related to outcome. The trial’s stated cohort definition is available, but the actual cohort size, Month 12 completion, missing-data approach, and sensitivity analyses are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Single-Arm, Open-Label Treatment With the Minitouc")
n      <- c(114)
events <- c(102)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Single-Arm, Open-Label Treatment With the Minitouc  114  102  89.5  82.3  94.4  82.5  93.9  82.5  93.8

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 27 outcome measures, including repeated descriptions of outcomes concerning subsequent intervention, amenorrhea, and dysmenorrhea-related pain. Having multiple outcomes raises a general multiplicity question: if many hypotheses are tested, the chance of at least one apparently notable result can increase unless the analysis plan accounts for multiple testing. The registry record does not report a multiplicity adjustment, a hierarchy of outcomes, or which outcomes were designated for confirmatory testing. It also lists 0 analyses, so results and inferential procedures for these outcomes are not available in the record.

Missing data are important for the primary Month 12 endpoint because the analysis requires an assessment at that time. The stated Intent-to-Treat Analysis Cohort includes eligible subjects in whom the procedure was initiated, but the record does not give the cohort’s size, the number with Month 12 PBLAC data, or the number missing that assessment. The missing-data assumptions and handling methods are not reported in the registry record. No imputation method, complete-case approach, or sensitivity analysis should be inferred.

The term Intent-to-Treat is defined by the record’s stated eligibility and procedure-initiation criteria. The record does not give enough detail to determine how that definition was applied to participants with missing outcomes or other post-initiation events. As a result, the relationship between enrollment, the analysis cohort, and the endpoint denominator remains unclear. These omissions limit assessment of selection, attrition, and the robustness of any endpoint result.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: atrial fibrillation (0.9%), covid-19 pneumonia (0.9%), spinal compression fracture (0.9%), syncope (0.9%).

The registry lists 3 participants with serious adverse events among 114 at risk and 109 participants with other adverse events among 114 at risk. It reports 0 deaths. The serious event terms listed are atrial fibrillation, COVID-19 pneumonia, spinal compression fracture, and syncope; each term is accompanied by 0.9% in the record. These are registry-reported counts and terms, not evidence by themselves that the device or procedure caused an event.

The at-risk counts are the denominators attached to the adverse-event summaries. They should not be assumed to match enrollment of 219 or the primary endpoint analysis population. The registry record does not explain why the adverse-event denominator is 114, describe the safety follow-up period, or state how events were assessed for relation to treatment. It also does not provide a comparison group, so these figures cannot estimate a relative risk versus another treatment or no treatment.

Serious adverse events and other adverse events are separate summaries in the registry; the record does not describe overlap between participants in those categories. The percentages attached to the listed serious-event terms should be read as reported, without recalculating them or inferring the number of unique affected participants. The counts describe what is entered in the registry, while attribution, timing, and comparative interpretation are not reported in the registry record.

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

The registry record identifies a prospective evaluation of a single endometrial ablation treatment and defines its primary endpoint as the number of participants with a PBLAC score of ≤75 at Month 12 post-procedure. It also provides a definition of the intended primary analysis cohort and lists safety counts. These details allow readers to understand what the study set out to assess and some aspects of the recorded study population.

The record does not report the primary endpoint result. It gives no number meeting the threshold, no analysis denominator, and no estimate of uncertainty. Therefore, it cannot establish from the posted results how many participants met the endpoint or how precisely that outcome was estimated. The study’s completed status and enrollment figure do not substitute for a posted outcome analysis.

Even if a within-group outcome estimate were available, this single-arm, non-randomized design would describe the treated group rather than provide a randomized comparison. A change after treatment would not by itself show what would have happened under a different care strategy. The record lists no comparator arm and no allocation to competing interventions. Accordingly, the design cannot support a direct comparative conclusion from randomized evidence.

The adverse-event counts also have a limited scope. They document events in the registry’s listed at-risk group, but the record does not provide enough information about attribution, timing, or comparative rates to establish causation or comparative safety. The listed secondary outcomes likewise cannot be interpreted without their reported results, denominators, and analysis details.

In general, a registry entry is a record of study information and posted results, not a replacement for a full protocol and analysis report. Here, key elements needed to judge the primary result—including its estimate, precision, missing-data handling, and statistical analysis—are not reported in the registry record. The appropriate interpretation is therefore bounded by the design and the results actually recorded, rather than an assumption about what an unreported analysis might have shown.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of how a clearly defined clinical endpoint and a limited study design answer different kinds of questions. The primary outcome uses a specified PBLAC threshold at a defined follow-up time, which makes the intended measure explicit. The registry also describes the participant cohort used for that endpoint. Those details help readers distinguish the outcome definition from the broader clinical topic of heavy menstrual bleeding.

At the same time, the single-arm design makes the interpretation of any observed outcome different from that of a randomized comparison. A count or proportion within one treated group can describe that group, but it cannot by itself separate treatment effects from other changes or influences. This distinction is important whenever a registry result is read as evidence about an intervention rather than as a description of participants’ outcomes.

The record’s missing endpoint estimate also illustrates why outcome definitions alone are not enough for statistical interpretation. A reader needs the numerator, denominator, and measure of uncertainty to assess the observed result and its precision. Without those elements, the endpoint can be understood conceptually, but its magnitude cannot be evaluated.

Finally, the number of listed outcome measures makes transparent reporting of the analysis plan and missing-data handling especially useful. Those details are not reported in the registry record. The study therefore highlights the value of separating what was planned, what was measured, and what was actually analyzed and posted. Its design and endpoint can be described, while quantitative claims about the primary outcome remain unavailable from the registry record.

15. Limitations

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

Several limitations specific to this trial constrain interpretation of the registry record. The study is single-arm, open-label, and non-randomized, with no comparator group. Thus it does not offer a randomized contrast against another intervention or a control condition. Any outcome measured within the treated group would not, on its own, isolate the effect of treatment from other influences.

The primary endpoint is a patient self-reported PBLAC measure classified using a threshold of ≤75 at Month 12 post-procedure. The threshold provides a clear definition, but it reduces the score to whether or not a participant met that criterion. The registry record does not report the endpoint count, score distribution, denominator, or confidence interval. It is therefore not possible to assess the observed result or its precision.

Although enrollment was 219, the primary analysis population is defined separately as eligible subjects in whom the procedure was initiated. The record does not state the number meeting this definition or the number with a Month 12 assessment. The missing-data approach and sensitivity analyses are not reported in the registry record, leaving uncertainty about endpoint completeness and how missing observations may have been handled.

The registry lists 27 outcome measures but does not report analyses, and the statistical plan, multiplicity approach, and original sample-size justification are not reported in the registry record. The adverse-event summaries use 114 participants at risk, but the record does not explain this denominator or specify event attribution and follow-up details. These limitations prevent detailed assessment of both effectiveness estimates and comparative safety from the registry information alone.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness — NCT04267562.
• Registry record last updated 2024-11-18; status last verified 2024-10.
• Results first posted 2023-10-23.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The EASE Clinical Trial is recorded as a completed, prospective, multicenter, single-arm, open-label, non-randomized evaluation of the Minitouch System for menorrhagia. Enrollment was 219. The recorded start date is 2020-02-28, and the primary completion date is 2022-07-20. The primary endpoint is the number of participants with a PBLAC score of ≤75 at Month 12 post-procedure, among a cohort defined by eligibility and procedure initiation.

The registry lists 27 outcome measures and 0 analyses. It does not report the primary endpoint count, its denominator, or an uncertainty estimate. The safety summary lists 3 participants with serious adverse events among 114 at risk, 109 with other adverse events among 114 at risk, and 0 deaths. The record does not report enough detail to establish event attribution or make a comparative safety assessment.