Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility (NCT05004012), a non-randomized na study. The primary outcome is Frequency of Contractions at Baseline.

2. Clinical Question

The title and brief summary frame the work as a feasibility study in gastric motility, rather than a randomized test of clinical benefit. Its central statistical question is whether contraction measurements from capsule endoscopy were reported in a way that permits comparison or characterization across the enrolled diagnostic groups. The registry record identifies the endpoint and its measurement scale, but does not report the observed median, inter-quartile range, or group-specific endpoint data. It therefore does not establish the size or precision of any differences in contraction frequency.

3. Trial Design

The registry describes the Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility, sponsored by the University of California, Los Angeles. Its status is completed. The recorded study start is 2021-12-01, and primary completion is recorded as 2023-05-22. Enrollment is listed as 20. The phase is recorded as NA.

The design is parallel and non-randomized, with no masking. The registry describes a control group, a gastroparesis group, a functional dyspepsia group, and a G-POEM group. The control description excludes gastroparesis, functional dyspepsia, and prior G-POEM. The other descriptions refer to participants with the corresponding diagnosis or procedure who met inclusion criteria. The registry states that no G-POEM patients were enrolled, so that group has no analyzed data.

Non-randomized allocation means that group membership was not assigned by random allocation, as far as the registry design fields indicate. Differences between groups could therefore reflect differences in their characteristics or clinical histories as well as differences in motility measurements. The registry also states that the arms are not a like-for-like control comparison. Results should not be read as if they came from a randomized comparison.

The listed intervention is magnetically controlled capsule endoscopy, classified as a device. The study summary describes an assessment of its utility for evaluating gastroparesis and functional dyspepsia. Detailed enrollment procedures, the device-use protocol, and the statistical plan are not reported in the registry record. The record lists five outcome measures and no analysis entries. These design details define what can be interpreted, but do not substitute for missing participant-level or group-level outcome results.

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: no G-POEM patients were enrolled so no data was analyzed

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: no G-POEM were enrolled in the study

6. Primary Endpoint

The registry lists the primary outcome as Frequency of Contractions at Baseline, measured over Comparison between stomach contractions at baseline (Stage 1/ before sham meal).

The primary endpoint is frequency of contractions at baseline, measured in stomach contractions per minute. The stated measurement time is before the sham meal, at Stage 1. The description characterizes the physiologic parameter as measuring the frequency and direction of stomach contractions at baseline. The endpoint title focuses on contraction frequency; the record does not provide a separate numerical result for direction.

The registry specifies the median as the summary measure and the inter-quartile range as the dispersion measure. In general, a median describes the middle of an ordered set of measurements, while an inter-quartile range describes the spread of the central portion of those measurements. These summaries can be useful when measurements are skewed or include values that make a mean and standard deviation less representative. That is a general statistical rationale, not a claim about the distribution in this study; the distribution is not reported in the registry record.

A baseline motility measure is relevant to the stated feasibility question because it characterizes stomach contractions before the sham meal. However, the registry does not report the median, inter-quartile range, number analyzed for this endpoint, or group-specific values. The endpoint definition therefore explains what was intended to be measured, but does not show what the measurements were or how precisely they were estimated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical information in the registry is limited. It identifies a median and inter-quartile range for the primary endpoint and records no analysis entries. It does not report the analysis population, missing-data procedures, adjustment methods, hypothesis tests, confidence intervals, or a prespecified statistical analysis plan. The methods below explain how such elements are generally interpreted; they are not claims that those methods were used in this study.

What does a median with an inter-quartile range describe?

For a set of measurements, the median is the central value after measurements are ordered. It is less affected by unusually high or low observations than the arithmetic mean. The inter-quartile range describes the spread between the lower and upper quartiles, giving a view of the central portion of the data. Reporting both can help readers understand typical values and variability without assuming that measurements follow a symmetric distribution. The registry names these summaries but does not report their observed values for the primary endpoint.

These summaries alone do not describe the precision of an estimated group difference. Precision is commonly conveyed with a confidence interval, which represents a range of values compatible with the data and the assumptions of the analysis. A narrow interval indicates more precise estimation than a wide interval. No confidence interval for the primary endpoint is reported in the registry record. Without the underlying summaries and an uncertainty measure, the direction and magnitude of a group contrast cannot be assessed.

Why does the non-randomized design matter?

Random allocation, when used, helps make comparison groups similar on average with respect to measured and unmeasured factors. In a non-randomized study, people enter groups according to diagnosis, procedure history, eligibility, or other circumstances rather than chance assignment. Groups may therefore differ in ways that affect the outcome. A raw difference in contraction frequency could reflect those group differences, the measurement process, or other influences; it would not by itself establish a causal effect of the device.

The registry specifically cautions that the arms are not a like-for-like control comparison. The record does not state whether adjustment was planned or performed, which variables would be considered, or whether adjusted results exist. General methods for addressing confounding include careful design, matching, stratification, or regression adjustment, but each depends on available information and assumptions. None should be attributed to this study without documentation.

What do the planning assumptions mean?

The stated planning framework describes an illustration based on an observed effect, not the trial's own design. It specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These assumptions describe how a hypothetical planning calculation may be structured. They do not establish that the study used those assumptions to choose enrollment, and the registry does not report a sample-size justification.

Planning calculations are conditional on their inputs. An illustration based on an observed effect asks what enrollment might be needed under chosen assumptions if a future study sought to detect a fraction of that effect. It is not observed power and does not show that the completed feasibility study was adequately powered. The record does not give the numerical observed effect or the planning outputs in the registry record for interpretation, so no planning value can be assessed. The stated general distinction is that time-to-event calculations are expressed as total events under a Schoenfeld approach, while other calculations are expressed as participants per arm.

Over-dispersion is a general issue when outcome variability exceeds what a statistical model assumes. If it is ignored, standard errors can be too small and confidence intervals too narrow, making estimates appear more precise than warranted. This concern can arise in count outcomes, but the registry does not report a count-data model or enough distributional information to determine whether over-dispersion was present or relevant to the endpoint analysis. The contraction rate is reported in contractions per minute, but that unit alone does not establish the model used.

What can be inferred from having no analysis entries?

The registry records no analysis entries. This means that inferential results such as test statistics, p-values, and analysis-specific estimates are not documented in the registry record. It does not identify why those entries are absent, nor does it establish that no analysis occurred outside the registry. Similarly, the primary outcome's population note and the lack of numerical results limit the ability to judge whether the planned endpoint was collected or analyzed in the non-G-POEM groups.

When interpreting any reported estimate, readers generally need to know the analysis population, outcome definition, handling of missing measurements, and method for estimating uncertainty. Those details help determine which participants contribute to a result and how robust it may be. The registry record does not report these elements for the primary outcome. Consequently, statistical interpretation should remain descriptive and bounded by the information recorded.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and no analysis entries. It does not report a multiplicity plan, such as a hierarchy of outcomes, adjustment of significance thresholds, or a strategy for interpreting multiple tests. In general, examining multiple outcomes or comparisons can increase the chance of finding an apparently notable result by chance. A prespecified strategy can help clarify which outcomes are confirmatory and how other findings should be treated. The record does not establish whether such a strategy existed outside the registry.

Missing-data methods are not reported in the registry record. The primary outcome population note says no G-POEM patients were enrolled, so no data was analyzed. The record does not describe missing measurements in the other groups, reasons for missingness, or any imputation or sensitivity analyses. A missing-data method matters because results can depend on which observations are available and why others are absent. Without these details, the extent and possible influence of missing endpoint data cannot be evaluated.

Analysis populations are also not reported. The registry does not state whether the primary endpoint was analyzed among all enrolled participants, only those with usable measurements, or another defined population. Enrollment is recorded as 20, but that figure does not establish how many contributed data to any particular outcome. No group-specific denominators for the primary endpoint are reported. The absence of analysis entries means there are no posted estimates or tests from which to determine the analysis population.

These omissions limit reproducibility and interpretation, but they do not demonstrate that a particular method was or was not used outside the registry record. The posted information is insufficient to assess multiplicity control, missingness, or the population underlying a numerical endpoint estimate.

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.

The adverse-event record lists no serious adverse events among 6 control participants at risk, no serious adverse events among 5 participants at risk in the gastroparesis group, and no serious adverse events among 5 participants at risk in the functional dyspepsia group. It also lists no other adverse events in those groups. Deaths are recorded as 0 in each of those groups. The G-POEM group has 0 participants at risk, with no events recorded.

These are event counts as recorded in the registry, not estimates showing that the risk is zero. A zero count in a group of limited size can occur even when an event remains possible; it does not precisely define the underlying event rate. The record does not report follow-up duration for safety, event definitions beyond the serious and other categories, or details of how adverse events were collected. Those omissions limit comparisons across groups and broader interpretation.

The G-POEM group should not be read as having reassuring safety results: there were no participants at risk in that group. The registry's zero event counts in that arm reflect the absence of an enrolled group, not observed safety experience. The reported counts provide a narrow descriptive account and do not establish a general safety profile.

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

The registry record establishes that a completed, non-randomized feasibility study was registered to assess magnetically controlled capsule endoscopy in evaluating gastroparesis and functional dyspepsia. It identifies contraction frequency at baseline, before the sham meal, as the primary endpoint and specifies a median with an inter-quartile range. These details make the intended measurement understandable.

However, numerical results for the primary outcome are not reported in the registry record. There are no posted medians, inter-quartile ranges, group contrasts, or confidence intervals in the information described. The record therefore does not show what contraction frequencies were observed or how precisely they were estimated. No conclusion about the size or direction of a difference between groups can be drawn from the endpoint definition alone.

The design also limits what group comparisons could mean. Participants were not randomly allocated, and the registry cautions that the arms are not a like-for-like control comparison. Even if group results were available, differences would need to be interpreted with attention to selection and other group differences. The record does not report adjustment methods that would support a causal interpretation.

The absence of G-POEM participants means that the study provides no analyzed outcome or safety experience for that described group. The safety record's zero event counts in the other groups are descriptive and do not prove that events cannot occur. The registry does not report enough detail about follow-up or event collection to support broader safety conclusions.

Thus, the posted record is useful for understanding the study's question, design, endpoint, and limits of the available reporting. It does not establish whether the device improves diagnosis, changes clinical outcomes, or performs better or worse than an alternative. Nor does missing numerical reporting establish that the device has no effect. The central result is not quantitatively interpretable from the registry information.

13. Why This Trial Matters Statistically

This study is statistically informative as an example of the difference between defining an outcome and reporting evidence about it. The registry specifies a physiologic endpoint, its unit, its summary measure, and its timing. Those elements are important for understanding what a study intends to measure. Yet without the observed values and uncertainty, readers cannot judge the magnitude, variability, or precision of the result.

The non-randomized structure is also important. Diagnostic groups and a control group may help characterize measurements across clinical categories, but the registry cautions that the arms are not a like-for-like comparison. That distinction prevents an observational group contrast from being mistaken for a randomized treatment effect. It also highlights why design, population definitions, and analysis methods need to be reported alongside estimates.

The feasibility framing draws attention to questions beyond statistical significance, such as whether the measurement was collected and how its results were summarized. The record does not report numerical primary results or analysis entries, so those questions remain unanswered in the registry. It also lists five outcome measures without documenting a multiplicity strategy, underscoring the value of explaining how multiple outcomes are interpreted.

Finally, the G-POEM group illustrates why denominators matter in safety and outcome reporting. A group with no participants at risk cannot contribute evidence about outcomes in that group. A zero event count among enrolled participants is also different from evidence that an event is impossible. Clear reporting of analyzed populations, missing data, uncertainty, and event ascertainment is necessary for readers to distinguish these situations.

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 main limitation for interpretation is the absence of numerical primary endpoint results in the registry record. Although the endpoint is defined as contraction frequency at baseline and the intended summary is median with inter-quartile range, those values are not reported. The record also lacks a reported group comparison and an uncertainty estimate, so neither effect size nor precision can be assessed.

The non-randomized design and the registry's warning that arms are not like-for-like constrain comparative interpretation. The record does not report adjustment methods or relevant participant characteristics that would help assess group comparability. It also does not describe the analysis population, endpoint-specific denominators, missing-data handling, or a statistical analysis plan. These gaps prevent assessment of how measurements were selected and analyzed.

No G-POEM patients were enrolled, leaving that described group without analyzed outcome data and without safety experience. The adverse-event counts for the other groups are limited descriptive observations; follow-up duration and event-collection details are not reported. The registry lists five outcomes and no analysis entries, but does not report how multiple outcomes were handled.

The study is described as a feasibility assessment, and the registry does not report a sample-size justification. Planning illustrations based on an observed effect are not evidence of the study's original design adequacy or observed power. Overall, these limitations arise from both the non-randomized design and incomplete statistical reporting. They restrict interpretation to the study's stated aims and recorded design details rather than supporting quantitative conclusions about performance or clinical effects.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility — NCT05004012.
• Registry record last updated 2026-04-29; status last verified 2026-04.
• Results first posted 2026-04-29.
• 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 feasibility study sponsored by the University of California, Los Angeles. Enrollment is listed as 20, and the study concerns magnetically controlled capsule endoscopy in gastric motility. The described groups are control, gastroparesis, functional dyspepsia, and G-POEM; no G-POEM patients were enrolled.

The primary endpoint is baseline stomach contraction frequency, measured before the sham meal and summarized by median and inter-quartile range. Numerical primary endpoint results, analysis entries, and details of missing-data handling, analysis populations, and multiplicity procedures are not reported in the registry record. The adverse-event record lists no serious or other adverse events and no deaths in the enrolled groups, with no participants at risk in the G-POEM group. These safety counts are descriptive and do not establish absence of risk.