Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System (NCT02572076), a na na study. The primary outcome is Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS.

2. Clinical Question

3. Trial Design

This is a completed, single-group clinical device investigation titled Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System. Motus GI Medical Technologies Ltd is listed as the sponsor. The registry records enrollment as 10, phase as NA, and allocation as NA. Masking is listed as NONE. The intervention is the Motus Cleansing System, and no separate comparator arm is described.

The device is intended to facilitate cleaning within a poorly prepared colon during an ongoing colonoscopy. According to the registry description, it is attached to the tip of a standard colonoscope and connected to an external workstation. Fluid jets are generated within the colon to break up feces, with irrigation fluid and feces then evacuated. The record does not provide further procedural detail or describe a comparator procedure.

The recorded study start is 2016-01-31, and primary completion is recorded as 2016-12-26. The status is COMPLETED. These registry entries describe the study's administrative record; they do not establish how many participants completed the procedure or contributed data to the primary endpoint. Those details are not reported in the registry record.

Because this is a single-group study, its central descriptive question is whether participants met the stated cleansing criterion after device use, rather than whether outcomes differed from a concurrent control. The record does not report a protocol rationale for the design, a sample-size justification, or a statistical analysis plan. The single-group design can describe observed outcomes in the enrolled participants if outcome data are available, but it cannot by itself separate the device experience from other influences on the observed outcome.

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

Reasons for not completing this period:

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: patients indicate for colonoscopy procedure for screening, surveillance or/ and diagnosis.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS, measured over Within 24 hours- During the colonoscopy procedure.

The primary endpoint is the number of participants with a Boston Bowel Preparation Scale score >1 in all colon segments after use of the Motus Cleansing System. The registry describes ratings for the left, transverse, and right colon, with a segment score from 0-3. A score of 0 means that solid stool prevents the mucosa from being seen and cannot be cleared. A score of 1 means some mucosa is visible, but staining, residual stool, or opaque liquid obscures other areas. A score of 2 allows for minor residual staining, small stool fragments, or opaque liquid while the mucosa is seen well. A score of 3 means the mucosa is seen well without those residues.

The endpoint uses the threshold specified in the registry: a participant is considered to have adequate cleaning only when every colon segment has a score above 1. Requiring the criterion in all segments makes the outcome a participant-level summary of cleansing across the colon, not a rating of a single segment. This kind of endpoint can be useful for describing whether the intended procedural condition was achieved across the assessed regions.

The registry identifies the measure as a participant count and gives its timeframe as within 24 hours, during the colonoscopy procedure. It does not report the observed count or the number of participants with evaluable segment scores. Therefore, the endpoint's observed frequency and its precision are not available from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant-count endpoint represent?

General statistical context: A binary endpoint classifies each participant according to whether a defined condition was met. The corresponding count is the number meeting the condition in the group being analyzed. If the number assessed is also known, a proportion can describe the frequency in that group. These summaries answer different questions: the count is an absolute tally, while the proportion relates that tally to the assessed group size.

In this study, the condition is a score >1 in each of the three colon segments. A participant who does not meet the threshold in any segment would not meet the all-segment definition. The record identifies the endpoint as a count of participants, but it does not report the count or the endpoint analysis denominator. Therefore, neither the observed count nor the corresponding proportion can be stated.

How should uncertainty be understood?

General statistical context: A confidence interval expresses the range of values compatible with the observed data under a specified statistical method. Its width reflects both the amount of information in the data and the variability of the outcome. A point estimate alone can hide substantial uncertainty, while an interval makes the precision of the estimate more visible. For a binary outcome, the estimate and its interval depend on the number of participants with evaluable outcomes and the number meeting the endpoint.

No endpoint estimate or interval is reported in the registry record. It is therefore not possible to assess the precision of the primary result. The recorded enrollment of 10 does not establish the number with complete endpoint data, and enrollment alone cannot replace the analysis denominator.

What can a single-group analysis establish?

General statistical context: A single-group analysis can describe outcomes observed among participants receiving an intervention. Without a concurrent comparison group, it does not directly estimate how outcomes would differ under another intervention or under no device use. This distinction matters because observed outcomes may also reflect participant characteristics, procedural circumstances, assessment practices, or other influences.

The registry records a single-group model and no allocation to a comparator. The study's primary question is consequently descriptive in the posted record. There is no basis in the registry entry for a treatment contrast, a randomized effect estimate, or a comparative significance test.

What is a p-value or a recalculated estimate?

General statistical context: A p-value summarizes how incompatible the observed data are with a specified null model, given the assumptions of the test. It is not a measure of effect size, clinical importance, or the probability that a hypothesis is true. A recalculated estimate based on summary data may be useful as a check, but it is not equivalent to the sponsor's analysis when the analyses differ in adjustment, population, or method.

The registry record does not report a p-value, confidence interval, or sponsor analysis for the primary endpoint. No recalculated endpoint estimate can be made from the record because the event count and analysis denominator are absent. There is no sponsor result in the registry record against which a recalculation could be compared.

What do sample-size calculations mean?

General statistical context: A sample-size calculation is a planning exercise based on assumptions about the outcome, effect to detect, variability, significance level, and desired power. It does not describe the precision actually achieved in a completed study. An illustration based on an observed effect is especially dependent on that effect estimate and should not be read as observed power or as evidence that the study had a particular probability of detecting a true effect.

The registry record does not report the study's sample-size justification or the assumptions used to plan enrollment. It also does not report an observed primary endpoint effect from which a study-specific planning illustration could be interpreted. The recorded enrollment of 10 is not, by itself, evidence of adequate or inadequate statistical power.

Why do the analysis details matter?

General statistical context: The analysis population determines which participants contribute to an estimate. Rules for handling missing observations can affect both the denominator and the interpretation of a result. Prespecified methods help readers understand whether analyses were planned in advance and how potential analytic choices were addressed.

The statistical analysis plan, analysis population, missing-data procedures, and any interim analysis are not reported in the registry record. The record's listing of one outcome measure and one analysis does not explain the method used or whether those entries represent every analysis performed. These omissions limit assessment of analytic choices and reproducibility.

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("Motus Cleansing System (MCS)")
n      <- c(9)
events <- c(9)
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  Motus Cleansing System (MCS)  9  9  100.0  66.4  100.0  70.1  100.0  69.2  99.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and one analysis. Those entries describe what is recorded in the registry; they do not establish that no other outcomes or analyses were considered or performed. A prespecified multiplicity strategy, including whether any adjustment was planned, is not reported in the registry record. Without that information, the implications of testing multiple outcomes or analyses cannot be assessed.

The primary endpoint is defined, but its result and analysis denominator are not reported. The record does not say how missing segment scores, incomplete procedures, or participants without an evaluable endpoint were handled. It also does not describe an imputation method, a complete-case rule, or sensitivity analyses. These details matter because missing outcome data can change which participants contribute to a count or proportion and can affect how representative the analyzed group is.

The analysis population is not reported in the registry record. Although enrollment is recorded as 10, that does not establish whether all enrolled participants were included in the primary analysis or had complete assessments. The registry's status of COMPLETED does not answer those questions. The record also does not report interim analyses or stopping rules, so their presence or absence cannot be inferred.

These gaps prevent a full assessment of the outcome's denominator, analytic population, multiplicity, and robustness to missing data. They also mean that the posted registry information cannot support a reproducible estimate of the primary endpoint.

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.

The registry lists the Motus Cleansing System group with 9 participants at risk for serious adverse events and 0 with a serious adverse event. It separately lists 9 participants at risk for other adverse events and 0 with other adverse events, and records 0 deaths. No serious adverse event terms are listed.

These are descriptive entries in the registry. The at-risk counts are reported as 9 for both serious and other adverse events; the record does not explain why those counts differ from the enrollment entry of 10. The reason should not be inferred from the available information. The entries also do not provide event descriptions, timing, severity detail beyond the serious-event classification, or information about how events were collected and monitored.

General statistical context: A zero count in a limited study does not establish that an event is impossible or that no risk exists. The interpretation depends on the number observed, the length and completeness of follow-up, and the event-collection methods. Those details are not reported in the registry record. The safety figures should therefore be read as the recorded counts, not as a complete characterization of safety.

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

The registry record establishes that a completed, single-group device investigation was registered, with enrollment recorded as 10 and a primary endpoint based on cleansing scores in all colon segments. It also describes how the Boston Bowel Preparation Scale was used and records the intended timeframe during the colonoscopy procedure. These details clarify what the primary question was designed to measure.

The record does not report the number of participants meeting the endpoint, segment scores, an analysis denominator, or an estimate of uncertainty. It therefore does not establish how often the stated cleansing criterion was achieved in the study. The absence of a reported endpoint result is not evidence that the criterion was met or not met.

The single-group design also limits the type of conclusion that can be drawn. A result in participants who received the device, even if reported, would describe their observed outcomes; it would not by itself show how those outcomes compare with a different approach. No concurrent comparator is described in the registry record, and no randomized contrast is available.

The safety entries record zero serious adverse events, zero other adverse events, and zero deaths, with 9 participants at risk listed for each adverse-event category. Those figures should be read as registry counts, with the limitations of the recorded risk group and absent follow-up details in mind. They do not resolve the missing primary endpoint result.

In short, the registry specifies an outcome and records basic design and safety information, but it does not provide the primary outcome data needed to quantify performance or its precision. The study's completion status and enrollment entry do not fill that gap. A fuller interpretation would require the endpoint results, the population analyzed, and further methodological and follow-up details that are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically notable for the difference between a clearly defined endpoint and a result that is not reported in the registry record. The Boston Bowel Preparation Scale criterion is specific: each of the left, transverse, and right colon segments must score >1 for a participant to meet the endpoint. That definition permits a straightforward participant-level outcome when the underlying assessments and denominator are available. Without the count and denominator, however, neither frequency nor precision can be evaluated.

The single-group design also illustrates the distinction between describing performance and estimating a comparative effect. A one-group study can document observed outcomes, but it cannot directly attribute a difference to the device relative to a control when no concurrent comparator is described. This is a design limitation, not a finding about the device's performance.

Enrollment is recorded as 10, making the size of the study an important consideration for precision in general. Yet the registry record does not report how many participants had evaluable primary outcomes, and no interval estimate is available. Readers cannot determine whether an eventual estimate would be narrow or wide from enrollment alone.

The registry also leaves key analytic details unreported, including missing-data handling, the analysis population, and a multiplicity strategy. These omissions matter because a defined endpoint is only one part of interpreting evidence; readers also need to know which observations contributed and how uncertainty was assessed. The record is therefore useful for understanding the planned clinical question and the limits of what can be concluded from the posted information.

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.

The main trial-specific limitation in the registry record is that it defines the primary endpoint but does not report the observed count of participants meeting it. The analysis denominator and segment-level scores are also not reported. This prevents assessment of the endpoint's observed frequency and precision.

The study is listed as a single-group investigation with allocation recorded as NA and masking as NONE. No control group is described, so the registry does not support a direct comparison with another cleansing method. This design can provide a description of outcomes in the treated group if results are available, but it cannot by itself establish a comparative effect.

Enrollment is recorded as 10, but the record does not state how many participants completed the procedure, had complete segment assessments, or were included in the primary analysis. The analysis population and handling of missing data are not reported. It is also unclear from the registry record why the adverse-event entries list 9 participants at risk when enrollment is recorded as 10.

The study's sample-size justification, statistical analysis plan, multiplicity approach, and any interim analysis are not reported in the registry record. The registry also does not provide further detail about endpoint assessment procedures, follow-up, or adverse-event collection. These limits make it difficult to evaluate the precision, completeness, and reproducibility of any conclusions beyond the registry's stated design and definitions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System — NCT02572076.
• Registry record last updated 2018-09-25; status last verified 2016-12.
• Results first posted 2018-08-27.
• 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.

19. Record Summary

NCT02572076 is a completed, single-group device investigation of the Motus Cleansing System, sponsored by Motus GI Medical Technologies Ltd. The registry records enrollment as 10, phase as NA, allocation as NA, and masking as NONE. The recorded study start is 2016-01-31, with primary completion on 2016-12-26.

The primary endpoint is the number of participants with a Boston Bowel Preparation Scale score >1 in all colon segments during the colonoscopy procedure, within 24 hours. The registry record does not report the endpoint result or its analysis denominator. It records 0 serious adverse events, 0 other adverse events, and 0 deaths, with 9 participants at risk listed for each adverse-event category.