Evaluation of the Performance of the Motus Cleansing System (MCS): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of the Performance of the Motus Cleansing System (MCS) (NCT03026075), a na na study. The primary outcome is Performance of MCS in Cleansing a Poorly Prepared Colon..

2. Clinical Question

The clinical question is about device performance in a specific procedural setting: colonoscopy where the colon is described as poorly prepared. Adequacy is defined using the scale's three colon segments, with each segment needing a grade of 2 or 3, described as good or excellent. The endpoint description says the bowel preparation level was assessed before and after use, while its stated timeframe is up to 2 hours.

This setup can describe whether participants meet the stated adequacy definition after the cleansing operation. It does not, by itself, establish how outcomes would compare with a separate treatment or procedure, because the registry record describes a single-arm study and no randomized control group. The number meeting the adequacy definition is not reported in the registry record, so the primary clinical question cannot be answered from the posted results information alone.

3. Trial Design

The registry record describes the evaluation as a multicenter, planned single-arm, open trial of the Motus Cleansing System during colonoscopy in poorly prepared colons. The recorded model is single group, masking is listed as none, and no allocation scheme is specified beyond an NA entry. The intervention is a device; the arm description identifies a standard colonoscopy procedure with the Motus Cleansing System.

Enrollment is recorded as 47. The study start is listed as 2016-12-22, primary completion as 2017-05-31, and status as completed. The registry identifies the sponsor as Motus GI Medical Technologies Ltd. The phase is listed as NA. These entries describe the trial’s registry design and status, but do not establish how participants were recruited, whether all enrolled participants received the device, or whether the outcome was available for everyone.

With no separate control arm, the design is suited to reporting the outcome observed in the treated group, but it cannot directly estimate a between-group treatment contrast. The pre- and post-cleansing assessments described for the bowel preparation scale are within-participant assessments; that does not make the study a randomized comparison. Any analysis of change over time would need to account for the relationship between measurements from the same participant, but the statistical method used for such an analysis is not reported in the registry record.

The record describes one primary outcome measure and one analysis, but it does not provide the analysis method or a numerical primary outcome result. It also does not report a protocol-based sample-size justification, the planned handling of incomplete assessments, or details of any interim analyses. A completed status indicates the registry lists the study as completed; it is not a substitute for the missing endpoint result.

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: The patients had reduced preparation in order to mimic poor bowel cleansing. the study bowel preparation consisted of dietary restrictions (no dried fruit, seeds or nuts) starting 2 days prior to colonoscopy, a 24-hour clear liquid diet and a split dose of 20 mg Bisacodyl (10 mg in each dose).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: the bowel preparation level before and after the use of Motus Cleansing System was evaluated using the Boston Bowel Preparation Scale (BBPS) where patients consider to have adequate cleansing level if all 3 colon segments graded 2 or 3 ( good or excellent)

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 Performance of MCS in Cleansing a Poorly Prepared Colon., measured over Up to 2 hours.

The primary endpoint concerns adequate cleansing of the colon after the cleansing operation. Adequacy is defined at the participant level: all three colon segments must receive a Boston Bowel Preparation Scale grade of 2 or 3, corresponding in the record to good or excellent. The assessment description refers to scoring before and after use of the device, and the stated timeframe is up to 2 hours.

This kind of endpoint turns segment-level scores into a clinically interpretable binary classification for each participant: adequate or not adequate under the stated rule. Reporting a count or proportion meeting the criterion can make the result easier to interpret than reporting only a collection of segment scores. However, the registry record identifies the parameter as a count of participants, and the actual number meeting the criterion is not reported in the registry record. No denominator for the primary endpoint or details on how missing segment scores were treated are given.

The threshold also matters to interpretation. A participant is classified as adequate only if every segment meets the stated grade requirement; a lower grade in any segment means the full criterion is not met. This is a definition of the endpoint, not evidence that the device caused a particular outcome. The record does not report a comparator group or a primary endpoint estimate, so the endpoint’s observed performance cannot be quantified from the registry information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a binary endpoint represent?

A binary endpoint assigns each participant to one of two outcome categories according to a stated rule. For this study, the rule defines adequate cleansing as grades of 2 or 3 in all three colon segments. The endpoint can therefore be represented by a count of participants meeting that rule and, when the number assessed is known, by a proportion. This makes the threshold and denominator essential parts of interpretation: the count alone does not indicate how common the outcome was, and the proportion cannot be reconstructed if the assessed group is unknown.

Binary outcomes are often analyzed using methods based on a binomial model. In general, that model treats each participant’s outcome as one of two possibilities and estimates the probability of the event of interest. The model relies on assumptions about how observations arise and how participants relate to one another. No specific model or calculation method for the primary endpoint is reported in the registry record, so it is not possible to say which method was used or whether its assumptions were checked.

Why does the denominator matter?

The enrollment count and the number contributing to an endpoint need not be the same. Participants may lack a complete assessment or may not meet analysis criteria, and the method used to handle such cases affects the denominator and sometimes the estimate. The registry record does not give a primary endpoint denominator or explain whether all enrolled participants had the required segment scores. Thus, the enrollment entry cannot be treated as the number with an observed primary outcome.

For a proportion, uncertainty is generally expressed with a confidence interval. The interval reflects sampling variability under a chosen statistical method and helps distinguish a precise estimate from one with substantial uncertainty. Different interval methods can behave differently, especially when event counts are sparse or close to an endpoint of the possible range. Since neither the endpoint count nor its interval is reported, no precision assessment is available for this outcome.

What does a single-group design allow?

A single-group analysis can estimate the frequency of an outcome in the group studied, provided the outcome and analysis population are sufficiently described. It does not create a concurrent estimate of what would have happened under a different intervention. Consequently, an outcome after device use is descriptive of this study group; it is not a direct estimate of a causal difference between the device and a comparator.

The endpoint description refers to scoring before and after the cleansing operation. When the same participants are assessed at more than one time, their observations are linked rather than independent. As a general statistical principle, an analysis of change should preserve that pairing or otherwise account for the within-participant relationship. The record does not describe whether the primary analysis compared pre- and post-procedure classifications, analyzed only the post-procedure status, or used another approach. The stated primary outcome title and description do not resolve that analytical detail.

How should precision and significance be distinguished?

A confidence interval communicates the range of values reasonably compatible with an estimate under a method; a significance test addresses a specified null hypothesis under a test procedure. Neither can be inferred from a count that is not reported. The registry record gives no primary endpoint estimate, confidence interval, test statistic, or p-value. It also does not report the significance level, the precise inferential objective, or whether the analysis was adjusted for any other factors.

Statistical significance and clinical relevance are different questions in general. A significance test does not describe the size of an effect or whether a threshold is important for practice. Conversely, an estimate’s practical meaning depends on the endpoint definition, the studied population, and the uncertainty around the estimate. Here, the absence of the primary result prevents either assessment. No conclusion about the magnitude or precision of cleansing performance can be drawn from the endpoint description alone.

What is not specified about the analysis?

The record does not report the statistical analysis plan, model, missing-data approach, or analysis population for the primary endpoint. It does not describe whether the assessment was conducted by blinded readers; masking is listed as none, but the record does not provide further detail about who knew the treatment status or who assigned the scale grades. It also does not report a sample-size justification or interim-analysis plan. These are distinct design and analysis details, and none should be inferred from the enrollment entry or completed status.

General planning calculations can illustrate how sample size depends on the assumed event frequency, effect to detect, significance threshold, and desired power. Such calculations are planning exercises, not evidence of the study’s actual power or a replacement for its observed outcome. The registry record does not state the assumptions used to plan this trial. In particular, the available information does not establish that enrollment was chosen to achieve a specified level of power for the primary endpoint.

For repeated or segment-level information, the analytic unit and aggregation rule also matter. The endpoint definition indicates that all three segment grades contribute to each participant’s classification, but the record does not give the segment-level data or an analysis of those data. A participant-level binary classification and a segment-level analysis answer different questions and would require their own clearly stated methods. Only the participant-level adequacy criterion is described for the primary outcome.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity concerns arise when multiple outcomes, comparisons, time points, or analyses are used to support claims. The registry record lists one primary outcome measure and one analysis. It does not provide enough detail to establish whether additional secondary outcomes or exploratory analyses were conducted, whether there were multiple time points considered, or whether any adjustment for multiple testing was planned. The number of registered primary measures alone does not establish the full scope of analyses performed.

The primary outcome description refers to assessment before and after the cleansing operation, but does not specify which time point or contrast defines the primary analysis. If more than one analysis was considered, the record does not say how the primary analysis was selected or how multiplicity was addressed. These details are not reported in the registry record, and no correction method should be assumed.

Missing data are also important for an endpoint based on three segment grades. The record does not state how an unscored segment, incomplete colonoscopy assessment, or absent post-procedure assessment was handled. It does not identify an analysis population such as all enrolled participants or those with evaluable measurements. Therefore, the available enrollment count cannot be assumed to be the primary outcome denominator.

The record does not report imputation, sensitivity analyses, or reasons for any missing outcome data. These omissions limit assessment of whether the outcome estimate, if available elsewhere, would be sensitive to missing observations or analysis choices. They also prevent reconstruction of the primary analysis from the registry entry. A careful interpretation should distinguish what is explicitly registered from analysis details that are not reported in the registry record.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists a serious adverse event count of 0 among 47 participants at risk in the Colonoscopy With MCS group. It lists 5 events in the other-event category among 47 at risk, and deaths are recorded as 0. No serious adverse event terms are listed.

These are counts in the registry’s safety categories. The entry does not describe the nature, timing, severity, or relationship to the device of the five other events. It also does not explain whether the other-event count represents participants with at least one event or a total event count, so that distinction should not be inferred. The serious-event denominator is a safety denominator and should not be treated as the primary endpoint denominator.

A zero recorded count is not equivalent to evidence that risk is absent. Safety counts from a single-arm study do not estimate a comparison with another procedure, and the record does not provide a comparative safety analysis. The listed counts should therefore be read as the registry’s reported safety information, not as a definitive assessment of safety.

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

The study addresses a defined procedural question: whether adequate cleansing, under the stated Boston Bowel Preparation Scale criterion, was recorded after use of the Motus Cleansing System in poorly prepared colons. The record describes a single-arm, open evaluation and provides an enrollment entry and safety counts. Those details characterize the study but do not reveal the primary performance outcome.

The central limitation for interpreting performance is that the registry record does not report how many participants met the adequacy definition, how many were assessed, or an estimate of the outcome’s precision. Without those data, it is not possible to quantify the rate of adequate cleansing or determine how uncertain an estimate would be. The endpoint definition tells the reader what would count as success for the registered measure; it does not tell whether or how often that criterion was met.

Even if an outcome estimate were available, a single-group study would describe results in the group studied rather than provide a direct comparison with an alternative. It would not by itself establish that the device caused the observed outcome, nor would it determine how results compare across different populations or settings. The record does not describe a randomized comparator, a comparative effect estimate, or an analysis that could support such a contrast.

The safety entries should be interpreted separately. They report zero serious adverse events and zero deaths, with five events listed in the other category. These entries do not fill the missing performance result, and they do not demonstrate that serious events are impossible or that safety is equivalent to another approach. The completed status indicates registry completion, not that every outcome or analysis is reported.

Accordingly, the record supports a description of the intended outcome, study structure, and posted safety counts. It does not support a numerical conclusion about cleansing performance, its precision, or a causal or comparative effect. The absence of these results is an information limitation, not evidence for either a favorable or unfavorable endpoint outcome.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of how endpoint definitions and study design determine what can be concluded. Its primary outcome uses a participant-level rule built from grades across three colon segments. That rule makes the meaning of adequacy explicit, but the resulting estimate still depends on a clearly reported count and denominator. Without those values, the endpoint is defined but cannot be evaluated quantitatively from the registry record.

The single-arm design is another key consideration. It can describe outcomes in the group receiving the device, but it does not supply a control-group outcome against which to estimate a comparative effect. Readers therefore need to separate a within-group performance description from a claim that an intervention outperforms another approach. The fact that the scale is assessed before and after the procedure does not replace a concurrent comparator, and repeated measurements would require analysis that accounts for their relationship.

The record also illustrates why enrollment, endpoint analysis, and safety reporting should not be conflated. Enrollment is not necessarily the number with complete primary outcome data, and a safety denominator is not automatically the endpoint denominator. A clear report would identify the analysis population, missing-data handling, outcome count, and uncertainty measure. Those details are not reported in the registry record.

Finally, registry completion and reported safety counts are not substitutes for primary results. The registry lists zero serious adverse events and zero deaths, but the principal cleansing outcome remains unreported. Statistically, the most important conclusion is therefore about the limits of the available evidence: the study question and threshold are specified, while the outcome estimate needed to judge performance is absent.

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 primary performance result is not reported in the registry record. The entry does not give the number meeting the adequate-cleansing criterion, the number assessed, or a measure of uncertainty. Consequently, the endpoint cannot be quantified from the registry information, and enrollment cannot be used as a substitute denominator.

The trial is described as single-arm and open, with no separate comparator. The design therefore does not provide a direct randomized comparison or a basis for estimating a between-group difference. Although the outcome description refers to scoring before and after use, the primary analysis is not specified, and the registry record does not explain how the two assessments were used analytically.

Other important analysis details are not reported in the registry record: the statistical method, analysis population, handling of missing segment scores, treatment of incomplete assessments, and any sensitivity analyses. The record does not state how the trial’s enrollment was justified or whether interim analyses were planned. Masking is listed as none, but further details on who assigned outcome scores are not given.

The safety information is also limited to category counts. The registry does not describe the five events in the other category or provide further context on timing, severity, or relationship to the device. The safety counts cannot establish comparative safety. More generally, the available record describes one trial setting and does not report results that would show whether findings apply to other populations or procedural contexts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of the Performance of the Motus Cleansing System (MCS) — NCT03026075.
• Registry record last updated 2019-02-11; status last verified 2017-06.
• Results first posted 2019-02-11.
• 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, multicenter, open, single-arm evaluation of the Motus Cleansing System during colonoscopy in poorly prepared colons. Enrollment is recorded as 47. The primary outcome is adequate cleansing by the Boston Bowel Preparation Scale, defined as grades of 2 or 3 in all three colon segments, with a timeframe of up to 2 hours.

The primary endpoint count and its precision are not reported in the registry record. The posted safety entries list 0 serious adverse events among 47 at risk, 5 events in the other category among 47 at risk, and 0 deaths. With no separate comparator group and no reported primary outcome result, the registry information does not establish a comparative effect or quantify cleansing performance.