This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease. (NCT03241368), a na na study. The primary outcome is Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03241368 |
| Phase | NA |
| Condition | Crohn Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 187 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medtronic - MITG |
| Results posted | Yes |
2. Clinical Question
Population
People with known Crohn’s disease and mucosal disease were the intended population. The primary analysis was defined for a per-protocol set of participants who underwent MRE, capsule endoscopy, and ileocolonoscopy, could be evaluated for disease activity, and had no major deviations. The registry record does not give the number in that analysis set or the complete set of exclusions.
Intervention
The procedure of interest was PillCam Crohn’s capsule endoscopy, described as a way to visualize the small bowel and colon. The study also included MRE and ileocolonoscopy procedures. A patency capsule was used if needed.
Comparator
The comparison was capsule endoscopy against ileocolonoscopy plus MRE. This was not a randomized comparison between separate groups: the registry describes a single-group study in which participants underwent the listed procedures. The comparison therefore concerns findings from diagnostic modalities, not outcomes in treatment arms.
Primary question
The primary objective was to assess the accuracy of capsule endoscopy versus ileocolonoscopy plus MRE for detecting active Crohn’s disease by visualizing the small bowel and colon. The registry states that accuracy was measured as a percentage of participants at baseline, with a mean and a 95% confidence interval. The numerical accuracy result and confidence interval are not reported in the registry record.
3. Trial Design
This completed, multicenter, prospective study enrolled 187 participants with Crohn disease. It is listed as a single-group study, with allocation recorded as NA and masking as none. The phase is also listed as NA. The study began on 2017-12-21, and primary completion was recorded as 2019-06-20.
Participants underwent MRE, capsule endoscopy, and ileocolonoscopy; a patency capsule procedure was included if needed. The registry describes capsule endoscopy as the device intervention, but the study was not structured as a randomized trial with separate treatment and control groups. Instead, the primary objective compared diagnostic accuracy for capsule endoscopy with accuracy for ileocolonoscopy plus MRE.
The study assessed mucosal disease activity at baseline. A patient satisfaction questionnaire was also completed at baseline. The registry describes central readers for videos and images. Capsule endoscopy and ileocolonoscopy results were read by gastroenterologists, while MRE results were read by radiologists. A consensus panel was to be used if results between modalities differed at baseline.
The scores named in the record were the Lewis Score, Simple Endoscopic Score for Crohn’s Disease Index score, and Magnetic Resonance Index of Activity score. The registry does not report the detailed protocol for turning these scores into the primary accuracy estimate, nor does it state a sample-size justification. The posted enrollment is not, by itself, evidence of the number included in the primary analysis.
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: Of the 187 subjects who signed informed consent, 29 failed inclusion/exclusion criteria and were exited from the study. Criteria included labs, which caused some subjects to wash out at this early phase. This left us with 158 subjects. For various reasons, 39 additional subjects were exited prior to all imaging procedures being completed.
Overall Study
| Stage | MRE, Patency Capsule (if Needed), CE, and IC |
|---|---|
| STARTED | 158 |
| COMPLETED | 119 |
| NOT COMPLETED | 39 |
Reasons for not completing this period:
| Reason | MRE, Patency Capsule (if Needed), CE, and IC |
|---|---|
| MRE Stricture or Patency Capsule Failure | 25 |
| Lost to Follow-up | 1 |
| Physician Decision | 6 |
| Withdrawal by Subject | 6 |
| Protocol Violation | 1 |
Analysis population for the primary outcome, as defined in the registry: Per-protocol analysis set, includes subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) who had no major deviations (violations that may have significant impact on outcomes) and did not meet following criteria: * Subject withdraws * Capsule remained in stomach or small bowel for entire procedure * Technical failure
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: Per-protocol analysis set, included subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) with no major protocol deviations (violations that may have significant impact on outcomes) and did not meet the following: subject withdraw; capsule remained in stomach or small bowel for entire procedure; system technical failure
| Characteristic | Unit | MRE, Patency Capsule (if Needed), CE, and IC |
|---|---|---|
| Participants analysed | 99 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 96 |
| Age, Categorical: >=65 years | Participants | 3 |
| Sex: Female, Male: Female | Participants | 63 |
| Sex: Female, Male: Male | Participants | 36 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Austria | participants | 2 |
| Region of Enrollment: United States | participants | 95 |
| Region of Enrollment: Israel | participants | 2 |
| BMI | kg/m² | 28.82 (SD 7.36) |
6. Primary Endpoint
The registry lists the primary outcome as Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease., measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns accuracy for detecting active Crohn’s disease in the small bowel and colon, comparing capsule endoscopy with ileocolonoscopy plus MRE. It is described as a percentage of participants, summarized by a mean and a 95% confidence interval, at baseline. This kind of endpoint is intended to describe how well findings from one diagnostic approach correspond to the study’s comparison approach in the target population.
Diagnostic accuracy is useful because a procedure may be evaluated not only for whether it produces an image, but also for how its findings classify disease activity. The registry names several assessment scores and says that central readers reviewed the videos and images. It also describes a consensus panel for discrepancies between modalities. However, the precise rule for classifying active disease, the mathematical definition of accuracy, and the handling of disagreements in the primary calculation are not reported in the registry record.
Most importantly, the registry record does not report the numerical primary endpoint estimate or its confidence interval. The stated endpoint and analysis approach can therefore be described, but the magnitude and precision of the observed accuracy cannot be assessed from the posted results in this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a diagnostic comparison within a single-group study, not a randomized comparison of separate groups. The question is whether capsule endoscopy’s assessment of active Crohn’s disease corresponds with the assessment based on ileocolonoscopy plus MRE. That design distinction matters: the findings should be read as a comparison of diagnostic procedures, not as evidence about the effect of assigning participants to different treatments.
The primary endpoint is described as a percentage of participants and as a mean with a 95% confidence interval at baseline. Yet the registry record does not report the primary estimate, its confidence interval, or the number of participants in the primary analysis set. It is therefore not possible to state from this record how high or low the measured accuracy was, or how precisely it was estimated. Neither a direction nor a magnitude of the primary result should be inferred from the objective or the endpoint description alone.
The record notes central review of videos and images, different reader specialties for capsule endoscopy and ileocolonoscopy versus MRE, and use of a consensus panel for discrepancies at baseline. These procedures describe how interpretation was organized. They do not, by themselves, establish that readers were blinded, that disagreements were resolved in a particular way in every case, or that one modality served as a definitive reference standard; those details are not reported in the registry record.
The registry lists secondary outcomes involving specificity, negative predictive value, positive predictive value, designated bowel segments, and patient satisfaction. It reports four outcome measures and one analysis, but the record does not include numerical results for these outcomes. Without those estimates and their uncertainty, the diagnostic properties cannot be evaluated separately or compared across bowel segments.
The safety record reports 7 participants with serious adverse events among 119 at risk, 11 with other adverse events among 119 at risk, and 0 deaths. These counts describe the posted safety record for the single group. They are not a comparison with an untreated or alternative-procedure control group, and the registry does not give a causal attribution for the events in the summarized figures.
In statistical terms, the record gives useful information about the planned measurement and study structure but does not include the primary numerical result needed to judge its size or precision. The completed status and enrollment do not fill that gap. Any conclusion about measured diagnostic accuracy would require the endpoint estimate and its uncertainty, which are not reported in the registry record.
9. Statistical Methods Explained
The primary endpoint is described as a mean of a continuous measure, expressed as a percentage of participants, with a 95% confidence interval. The registry’s use of a mean does not change the fact that the reported scale is a percentage. The exact computation behind that measure is not reported, so it is not possible to reconstruct the endpoint or determine precisely how participant-level classifications contributed to the mean.
What a confidence interval conveys
General statistical explanation: A confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while the interval’s location indicates the range of values compatible with the data and method. It is not a guarantee that the true value lies within the particular interval, and it does not on its own establish that a finding is important. For this study, the registry specifies a 95% confidence interval but does not report its endpoints, so its precision cannot be assessed.
How to understand the diagnostic comparison
The stated comparison is capsule endoscopy versus ileocolonoscopy plus MRE. In general, diagnostic accuracy depends on how a test’s classifications are compared with a defined reference or comparator classification. Sensitivity describes identification of those classified as having the condition; specificity describes identification of those classified as not having it. Positive and negative predictive values describe the probability of the corresponding classification in the population being assessed. These are general definitions, not a claim about the study’s numerical findings.
The registry lists sensitivity, specificity, positive predictive value, and negative predictive value among secondary outcomes, including analyses for designated bowel segments. It does not report the numerical results or give enough detail to determine the exact classification thresholds, reference rules, or calculation procedures. Thus, these diagnostic terms identify the properties the study intended to assess, but they do not allow those properties to be quantified from the record.
Reader procedures and disagreement
The record says central readers reviewed all videos and images. Gastroenterologists read capsule endoscopy and ileocolonoscopy results, and radiologists read MRE results. A consensus panel was to be used if there were discrepancies between modalities at baseline. Such procedures can support consistent interpretation, but the registry does not report reader blinding, the number of readers, agreement statistics, or the detailed consensus procedure. Those methodological features should not be assumed.
The named scores were the Lewis Score, Simple Endoscopic Score for Crohn’s Disease Index score, and Magnetic Resonance Index of Activity score. The record does not explain how these scores were combined, which thresholds defined active disease, or how the score results were translated into the primary accuracy measure. It also does not state whether a particular modality was treated as the definitive reference for the primary analysis.
Study structure and analysis population
The study is listed as single-group, with no masking and allocation recorded as NA. Participants underwent the diagnostic procedures rather than being assigned to randomized comparison arms. Consequently, a conventional treatment-effect comparison between independent arms is not the design described by the registry. The primary analysis population is described as per-protocol: participants had to undergo MRE, capsule endoscopy, and ileocolonoscopy, be evaluable for Crohn’s disease activity, and have no major deviations. The text also lists withdrawal and a capsule remaining in the stomach or small bowel among exclusion criteria, but the full description is truncated in the registry record.
In general, a per-protocol population focuses analysis on participants who meet specified adherence and evaluability conditions. This may differ from an analysis of everyone enrolled, and the result can depend on who is excluded. The record does not report the size of the primary analysis set, the number excluded, or a full account of missing observations. Therefore, the effect of exclusions on the estimate cannot be assessed.
Precision and planning
General statistical explanation: The precision of an estimate depends on factors such as the amount of information in the analysis and variability in the observations. A confidence interval is one way to communicate that precision. The registry lists enrollment of 187, but that figure does not establish how many participants contributed to the primary analysis or how precise its estimate was. The endpoint result and interval are absent from the registry record.
The registry does not report the trial’s sample-size justification, assumptions used in its design, or any interim analyses. Any planning illustration calculated from an observed effect is a hypothetical design exercise, not observed power and not evidence of the study’s original planning. The record does not provide a primary effect estimate from which to assess how such an illustration relates to this study.
Finally, the registry lists one analysis and four outcome measures. That information alone does not establish how multiple outcomes were handled statistically. Whether adjustments were made, outcomes were prioritized beyond the stated primary objective, or analyses were prespecified in a detailed statistical plan is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and one analysis. It names the primary accuracy objective and secondary outcomes covering diagnostic measures for the small bowel and colon, designated bowel segments, and patient satisfaction. The record does not describe a multiplicity strategy, such as adjustment of significance thresholds or a hierarchy among secondary outcomes. It also does not report a detailed statistical analysis plan. The presence of multiple outcomes should therefore be recognized, but the record does not support a claim about how multiplicity was handled.
The primary analysis population is described as per-protocol. Participants had to undergo MRE, capsule endoscopy, and ileocolonoscopy, be evaluable for disease activity, and have no major deviations. The record lists withdrawal and a capsule remaining in the stomach or small bowel among exclusion criteria, but the criteria text is incomplete. The total number screened, the number excluded, reasons for exclusion, and the number in the final analysis set are not reported in the registry record.
Missing-data methods are also not reported. The record does not state how incomplete or unevaluable examinations were treated, whether missing results were imputed, or whether sensitivity analyses examined the effect of missingness. These omissions matter because the analysis is restricted to participants meeting the stated per-protocol conditions. Without participant-flow counts and missing-data details, the representativeness of the analyzed group cannot be assessed.
The record names baseline as the primary timeframe and says the satisfaction questionnaire was completed at baseline. It does not give further detail about the timing of secondary assessments or how incomplete questionnaire responses were handled. These details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| MRE, Patency Capsule (if Needed), CE, and IC | 7 | 119 | 5.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| MRE, Patency Capsule (if Needed), CE, and IC | 0 of 119 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| MRE, Patency Capsule (if Needed), CE, and IC | 11 of 119 |
Most frequent serious adverse event terms
| Event term | Organ system | MRE, Patency Capsule (if Needed), CE, and IC |
|---|---|---|
| Crohn's Disease | Gastrointestinal disorders | 3 of 119 |
| Abdominal pain | Gastrointestinal disorders | 1 of 119 |
| Complication of device removal | General disorders | 1 of 119 |
| Clostridium difficile infection | Infections and infestations | 1 of 119 |
| Serum sickness | Immune system disorders | 1 of 119 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MRE, Patency Capsule (if Needed), CE, and IC |
|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 1 of 119 |
| Constipation | Gastrointestinal disorders | 1 of 119 |
| Haematochezia | Gastrointestinal disorders | 1 of 119 |
| Haemorrhoids | Gastrointestinal disorders | 1 of 119 |
| Infusion site extravasation | General disorders | 1 of 119 |
| Oesophageal candidiasis | Infections and infestations | 1 of 119 |
| Staphylococcal skin infection | Infections and infestations | 1 of 119 |
| Infusion related reaction | Injury, poisoning and procedural complications | 1 of 119 |
| Post procedural complication | Injury, poisoning and procedural complications | 1 of 119 |
| Haemoglobin decreased | Investigations | 1 of 119 |
Serious events with the highest arm-level rate: crohn's disease (2.5%), abdominal pain (0.8%), complication of device removal (0.8%), clostridium difficile infection (0.8%), serum sickness (0.8%).
The registry reports safety figures for the single group described as MRE, patency capsule if needed, capsule endoscopy, and ileocolonoscopy. There were 119 participants at risk in the serious-adverse-event summary, with 7 affected participants, and 119 at risk in the other-adverse-event summary, with 11 affected participants. The record lists 0 deaths.
These are counts within the posted safety group, not a comparison against a separate control group. The registry does not establish from these figures whether an event was caused by a particular procedure, nor does it state whether the same participant could appear in both adverse-event categories. The counts should not be added or treated as mutually exclusive categories.
The record lists Crohn’s disease at 2.5% among the leading serious-event terms, followed by abdominal pain, complication of device removal, Clostridium difficile infection, and serum sickness, each at 0.8%. The denominator and event-counting basis for these term percentages are not specified in the registry record, so they should be read as registry-listed percentages rather than independently interpreted rates.
Safety counts provide descriptive context. They do not establish a comparative risk or explain the circumstances, timing, or attribution of individual events.
12. What the Result Does, and Does Not, Mean
The study asks a diagnostic question: how capsule endoscopy compares with ileocolonoscopy plus MRE for identifying active Crohn’s disease in the small bowel and colon. It is not a trial of a treatment against a control treatment. The study is listed as single-group, and participants underwent the procedures used in the comparison.
The registry record gives the intended primary measure, its baseline timeframe, and the planned summary as a mean percentage with a 95% confidence interval. It also describes central image review, reader specialties, and a consensus panel for discrepancies. These details explain the broad measurement framework, but the record does not report the primary estimate or confidence interval. It therefore does not allow a quantitative judgment about the observed accuracy or its precision.
The named secondary outcomes indicate that the study also considered specificity, sensitivity, predictive values, bowel segments, and patient satisfaction. Numerical results for these outcomes are not reported in the registry record. No conclusion about a specific diagnostic property or satisfaction finding should be drawn from the outcome names alone.
Likewise, enrollment of 187 does not mean that all enrolled participants were included in the primary per-protocol analysis. The analysis set required participants to undergo all three procedures, be evaluable, and have no major deviations; its size is not reported. The complete exclusion criteria and missing-data methods are also absent, limiting assessment of how the analysis population was formed.
The safety summary reports 7 participants with serious adverse events among 119 at risk, 11 with other adverse events among 119 at risk, and 0 deaths. These are descriptive counts in the study group and do not provide a controlled comparison or establish causation.
Overall, the registry record supports a description of the study question, procedures, analysis population, and safety summaries. It does not provide the numerical primary result needed to judge the diagnostic comparison. Any broader interpretation should remain limited to those reported details.
13. Why This Trial Matters Statistically
This study is statistically interesting because it evaluates two diagnostic approaches within a prospective, single-group design rather than comparing randomized treatment groups. That makes the structure of the diagnostic comparison central to interpretation. The reader needs to know how disease activity was classified, what counted as agreement, and how discrepancies were resolved. The registry describes central review and a consensus panel, but does not report the full classification and calculation rules.
The study also uses multiple kinds of assessment. Capsule endoscopy and ileocolonoscopy were read by gastroenterologists, while MRE was read by radiologists, and the record names different scoring systems. This makes the operational definition of the comparator and the process for reconciling findings important statistical considerations. Details such as thresholds, blinding, and agreement measures are not reported in the registry record.
The endpoint is stated as a percentage of participants with a mean and 95% confidence interval, yet the numerical estimate and interval are absent. This illustrates why an endpoint definition alone is not enough for statistical interpretation: an estimate conveys the observed result, and its interval conveys uncertainty. Without them, neither the magnitude nor precision of the diagnostic finding can be assessed.
The per-protocol population also deserves attention. Requiring participants to complete all procedures and be evaluable may shape which observations contribute to the analysis. The final population size and full exclusion details are not reported, so the consequences of these criteria remain unclear.
Finally, the safety figures are descriptive and come from a single group. They provide event counts, but not a comparative safety estimate. Together, these features show why study design, analysis population, endpoint definition, and completeness of reporting all matter when interpreting diagnostic research.
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 most important limitation of interpretation is that the registry record does not report the primary accuracy estimate or its 95% confidence interval. Although the endpoint and intended summary are described, the observed result and its precision cannot be evaluated.
The primary analysis population is per-protocol, but its size is not reported. The eligibility description includes participants who underwent MRE, capsule endoscopy, and ileocolonoscopy, were evaluable for disease activity, and had no major deviations. The listed exclusion text is incomplete, and the registry does not report participant flow, full exclusion criteria, or missing-data methods. These gaps prevent assessment of how the analyzed population relates to all enrolled participants.
The record identifies scores and reader procedures, but does not give the thresholds or detailed rules used to classify active disease or calculate accuracy. It also does not report blinding, reader agreement, or the specific role of the consensus panel in the final calculation. These details are relevant when interpreting agreement among diagnostic modalities.
The study is single-group, with no masking, and is not a randomized comparison. The safety figures therefore lack a separate control group for estimating comparative event rates. The registry also does not specify attribution for the adverse events or the denominator used for the listed serious-event term percentages.
Finally, the registry does not report a sample-size justification, interim analyses, detailed statistical plan, or multiplicity strategy. These items should be treated as unreported rather than inferred from the study’s completed status or enrollment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease. — NCT03241368.
- Registry record last updated 2020-06-09; status last verified 2019-10.
- Results first posted 2020-06-09.
- 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.
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18. Record Summary
NCT03241368 is a completed, multicenter, prospective, single-group study of capsule endoscopy compared with ileocolonoscopy plus MRE for detecting active Crohn’s disease in the small bowel and colon. The record lists enrollment of 187, no masking, and a per-protocol primary analysis population. Participants underwent MRE, capsule endoscopy, and ileocolonoscopy, with a patency capsule if needed.
The primary endpoint was a baseline percentage of participants, summarized as a mean with a 95% confidence interval. Central image review, reader specialties, and a consensus panel for discrepancies are described. The numerical primary result, its confidence interval, the final analysis-set size, and several statistical-plan details are not reported in the registry record.
The safety record lists 7 participants with serious adverse events among 119 at risk, 11 with other adverse events among 119 at risk, and 0 deaths.