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 Preliminary Evaluation of CASTLE Barrier Prototype UK (NCT01530087), a na na study. The primary outcome is Peristomal Skin Condition.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01530087 |
| Phase | NA |
| Condition | Peristomal Skin Complication |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hollister Incorporated |
| Results posted | Yes |
2. Clinical Question
Population
People with intestinal stomas and irritated peristomal skin were the intended study population. The registry record lists peristomal skin complication as the condition and reports that 3 participants were enrolled. It also describes the safety and performance assessment as preliminary and involving a small population. The record does not report further eligibility details or a more specific description of the participants’ skin condition at enrollment.
Intervention
The intervention was the CASTLE barrier, described as a novel barrier formulation and classified as a device in the registry record. The treatment description identifies the CASTLE Barrier. The record does not report details about how participants applied it or how use was monitored.
Comparator
There was no separate comparator group. The study is recorded as single-group, with allocation listed as NA. This means the registry record does not describe a randomized or parallel-group comparison with another barrier, usual care, or no intervention.
Primary question
The primary outcome was peristomal skin condition, assessed as a mean irritation score on a categorical scale ranging from 1 (normal) to 5 (eroded or heaemorrhagic dermatitis), over the stated timeframe of 1 - 30 days. The intended question was whether skin condition could be assessed during a preliminary evaluation of the prototype. The registry record says the study stopped because it could not enroll participants and that no data are available for any outcome measures. It therefore supplies no observed score and no estimate of change or performance.
3. Trial Design
NCT01530087 is a registry record for the study titled “Preliminary Evaluation of CASTLE Barrier Prototype UK.” It identifies Hollister Incorporated as the sponsor and records the study as a single-group evaluation. The intervention was the CASTLE barrier, a device. No distinct control arm is described, and allocation is listed as NA. Masking is listed as NONE, so the record does not describe blinded assessment or treatment assignment. The phase is listed as NA.
The record gives an enrollment of 3. The study start is recorded as 2012-01 and primary completion as 2012-02. Its status is TERMINATED. The primary outcome timeframe is described as 1 - 30 days. The registry summary says the study was stopped because of inability to enroll and that there are no data available for any outcome measures. Thus, these dates and enrollment details describe the registered study, not a completed assessment of the primary endpoint.
The stated purpose was a preliminary assessment of safety and performance of a novel barrier formulation among people with irritated peristomal skin. The record lists peristomal skin complication as the condition. It identifies peristomal skin condition as the primary outcome and Security as a secondary outcome. The registry record does not report a protocol justification for selecting a single-group design, a target enrollment, or a statistical analysis plan. Nor does it report a comparator intended to separate changes associated with the barrier from changes over time or other influences. The design therefore offers no randomized between-group contrast, and the absence of outcome data means that even a within-group description cannot be made from the posted 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
| Stage | Subjects With Ileostomy or Colostomy |
|---|---|
| STARTED | 3 |
| COMPLETED | 1 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Subjects With Ileostomy or Colostomy |
|---|---|
| Physician Decision | 2 |
Analysis population for the primary outcome, as defined in the registry: Study was stopped due to inability to inability to enroll. No data are available for any outcome measures.
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.
| Characteristic | Unit | Subjects With Ileostomy or Colostomy |
|---|---|---|
| Participants analysed | 3 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 2 |
| Region of Enrollment: United Kingdom | participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Peristomal Skin Condition, measured over 1 - 30 days.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled Peristomal Skin Condition. It is described as the mean irritation score using a categorical scale from 1 (normal) to 5 (eroded or heaemorrhagic dermatitis), with a timeframe of 1 - 30 days. This endpoint focuses on the condition of skin around the stoma, the specific clinical concern identified in the study summary. A score scale can provide a structured way to record observations rather than relying only on an unstructured description. The registry record does not report additional details about assessment visits, who assigned scores, or how scores were combined across the stated timeframe.
In general, a mean can give a compact summary of scores, but the scale is categorical and ordered. Interpreting a mean as if the difference between each adjacent category were identical requires an assumption about the spacing of the categories. That is a general measurement consideration, not evidence about how the investigators analyzed these data. The registry record does not state whether the endpoint was intended to represent a baseline score, a change from baseline, or another summary beyond the description of a mean irritation score.
No endpoint observations are reported. The record explicitly says that no data are available for any outcome measures because the study was stopped due to inability to enroll. Consequently, there is no reported mean, variability estimate, or basis for describing the skin condition observed during the study.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the registry record reports no outcome data. Although 3 participants were enrolled, the record states that the study stopped because of inability to enroll and that no data are available for any outcome measures. There is therefore no observed primary endpoint value to interpret. In particular, the record does not report a mean irritation score, a change in score, a spread of scores, or an estimate of uncertainty around an effect.
The primary endpoint was a mean score on a categorical scale ranging from 1 (normal) to 5 (eroded or heaemorrhagic dermatitis), over 1 - 30 days. Those endpoint details define what the investigators planned to assess; they are not results. The registry record does not establish whether any participant’s skin condition improved, worsened, or remained the same. It also does not allow the precision of an estimate to be judged, because no estimate or confidence interval is reported.
The design was single-group, and allocation is listed as NA. Even if outcome measurements had been available, a single-group description would not provide a randomized contrast against a separate control group. General changes over time, concurrent care, measurement variation, or other influences could not be distinguished from an intervention-associated pattern using a randomized between-group comparison in this design. Since the record contains no outcome observations at all, it supports no estimate of a within-group pattern either.
The posted safety figures list 3 people at risk for both serious and other adverse events in the group titled Subjects With Ileostomy or Colostomy. The reported counts affected are 0 for serious adverse events and 0 for other adverse events. These are the registry’s safety counts, but they do not fill the gap in the primary outcome record. Deaths are not reported in the registry record. The absence of reported events in these counts should be read as a description of what the record lists, not as evidence that risk is absent or precisely characterized.
The study status is TERMINATED, with the registry summary attributing stopping to inability to enroll. The record does not report a recruitment target or explain why enrollment was not achieved. With no outcome data and no separate comparator, the registered study cannot answer its intended performance question statistically. This is an absence of evaluable evidence in the posted results, not a finding that the intervention had a particular effect or no effect.
9. Statistical Methods Explained
The registry record identifies a single-group study with no allocation to a separate comparison arm. It lists masking as NONE and phase as NA. The intervention is the CASTLE barrier, classified as a device. These design labels describe how the study was registered; the record does not provide a detailed protocol or statistical analysis plan. In particular, the registry record does not report a planned model for the primary outcome or a procedure for comparing scores over time.
What does a single-group design estimate?
In general, a single-group study can describe outcomes observed among participants who receive an intervention, if measurements are collected and reported. Without a concurrent comparison group, it cannot directly estimate how those outcomes differ from what would have occurred under a different treatment condition. A randomized comparison is useful because random assignment can balance, on average, influences other than the assigned intervention. This study has no such randomized contrast in the registry record. Here, there are also no reported outcome observations, so the record does not support even a descriptive estimate of the observed skin scores.
What would a mean score represent?
The primary endpoint is described as a mean irritation score on a categorical scale ranging from 1 (normal) to 5 (eroded or heaemorrhagic dermatitis). In general, a mean summarizes the numerical scores by their arithmetic average. For an ordered categorical scale, interpreting that average as a measure of distance assumes that the steps between categories can be treated as comparable. The registry record does not explain whether investigators considered that assumption or planned another summary. No mean or component scores are reported, so no endpoint result can be interpreted.
How should precision be assessed?
In general, a confidence interval describes a range of values compatible with the data under a specified statistical procedure and communicates uncertainty in an estimate. Its width depends on factors including the amount and variability of observed information and the method used. A confidence interval cannot be recovered from the registry record because no primary outcome estimate or variability is available. There are no reported confidence limits for the primary endpoint, and no effect estimate to which such limits could attach. The absence of an interval should not be mistaken for a narrow interval or a precise result.
What is over-dispersion, and does it apply?
In general, over-dispersion occurs when the observed variability in data is greater than a statistical model expects. It can affect standard errors and confidence intervals when a model assumes less variability than the data contain. Whether over-dispersion is relevant depends on the outcome and analysis model. The registry record does not report an analysis model, outcome observations, or a dispersion estimate. It is therefore not possible to determine whether over-dispersion was assessed or whether it would matter to an analysis of this study.
What can planning calculations tell us?
In general, sample-size planning uses assumptions about the effect to detect, variability, significance level, allocation, and statistical method. The registry record does not report its own sample-size justification, recruitment target, or planned analysis assumptions. Any sample-size illustrations based on an observed effect are planning illustrations, not observed power and not a substitute for trial results. Here, no observed effect is available in the posted results, so no effect-based planning interpretation can be grounded in the study’s outcome data. The record’s absence of a result does not permit an effect estimate to be reconstructed.
The study lists Security as a secondary outcome and identifies 2 outcome measures in total. It reports 0 analyses. These registry entries do not identify which statistical tests, models, or summary measures were planned or performed. The record also does not report the number of assessment occasions or a procedure for handling repeated measurements within a participant. Any such analytic details are not reported in the registry record.
For safety, the posted counts distinguish participants at risk from participants affected by serious or other adverse events. In general, counts and denominators can describe the events recorded in a study, but their interpretation depends on the collection and reporting procedures. This record lists 3 at risk and 0 affected in each adverse-event category. It does not give additional detail about event definitions, ascertainment methods, or observation time for the safety outcomes. The listed counts should therefore be read narrowly as registry-reported figures, not as a comprehensive statistical assessment of safety.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies Peristomal Skin Condition as the primary outcome and Security as a secondary outcome. It also reports 2 outcome measures and 0 analyses. It does not describe an adjustment for multiple outcomes, a hierarchy among secondary outcomes, or a strategy for controlling the chance of false-positive findings when several outcomes are examined. Those analysis details are not reported in the registry record. Because no outcome data are available, there are no reported statistical tests or estimates whose interpretation could be affected by multiplicity in the posted results.
The record explicitly attributes the lack of outcome data to stopping because of inability to enroll. This means the primary statistical issue is that the outcomes were not available for analysis, rather than a reported pattern of incomplete values among participants. The registry record does not describe whether any partial measurements were collected, whether assessments were attempted, or how missing observations would have been handled. A missing-data method, if planned, is not reported in the registry record.
The registry record does not define analysis populations, such as a population based on enrollment, intervention use, or completion of assessments. It also does not report how participants would be included in analyses or whether any exclusions were planned. With no outcome data and no analysis reported, it is not possible to identify an analyzed population or assess how its definition might affect results. These omissions should not be replaced with assumptions about the investigators’ intended procedures.
In general, multiplicity concerns arise when multiple hypotheses or outcomes are tested, while missing-data methods address how analyses handle outcomes that were not observed. They are distinct issues. In this record, the listed outcomes and lack of reported analyses identify the relevant reporting gaps, but they do not establish that any particular adjustment or missing-data approach was used.
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 |
|---|---|---|---|
| Subjects With Ileostomy or Colostomy | 0 | 3 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Subjects With Ileostomy or Colostomy | 0 of 3 |
The safety group is titled Subjects With Ileostomy or Colostomy. The registry record lists 3 participants at risk for serious adverse events and 0 affected. It also lists 3 at risk for other adverse events and 0 affected. These figures are counts as posted in the registry; they do not represent a comparison with another group because the study is single-group.
The deaths field is not populated with a count, so deaths are not reported in the registry record. A blank or unreported value should not be converted into a zero. The record also does not provide further details about the definitions of serious and other adverse events, the method of collection, the observation period for safety, or the completeness of event reporting. Those details are not reported in the registry record.
In general, a count of zero affected participants means that no affected participants are listed for that category in the posted record. It does not, by itself, establish that an event cannot occur or precisely quantify the safety profile of an intervention. Here, the small enrolled group and the absence of outcome data limit what can be inferred from the safety counts. These figures should be read as registry-reported observations only, not as a definitive estimate of risk.
12. What the Result Does, and Does Not, Mean
The registry record documents an intended preliminary evaluation of the CASTLE barrier in people with irritated peristomal skin. It describes a primary skin-condition measure and provides limited safety counts. It also records that the study was terminated after difficulty enrolling participants. The record’s most important result is that no data are available for any outcome measures.
That absence means there is no reported primary endpoint score and no estimate of how skin condition changed during the stated timeframe of 1 - 30 days. There is no reported uncertainty interval, variability estimate, or statistical comparison. The record therefore does not show a direction or magnitude of effect. It cannot support a conclusion that the barrier improved or worsened skin condition, or that it had no effect.
The study is single-group, with allocation listed as NA. It does not include a randomized control group in the registry record. Even in a study with collected outcomes, the lack of a concurrent comparator would limit the ability to distinguish an intervention-associated pattern from other influences. In this case, no outcome observations are reported, so there is no pattern to describe in the first place.
The safety record lists 0 participants affected by serious adverse events and 0 affected by other adverse events among 3 at risk in each category. These counts describe the posted record, but they do not establish a complete or precise safety profile. Deaths are not reported in the registry record, and further safety-collection details are also not reported.
Accordingly, the study record is informative about the intended question, the registered design, the enrollment outcome, and the lack of posted outcome data. It does not provide an estimate of treatment effect or an evidential basis for a claim about performance. The distinction matters: a study with no reported outcome data is not the same as a study whose results demonstrate no effect. The posted results leave the primary question unanswered.
13. Why This Trial Matters Statistically
This study illustrates why a registry entry’s design and outcome availability must be considered alongside its stated objective. A clear endpoint description can identify what investigators intended to measure, but it cannot substitute for participant-level observations or a reported summary. Here, the record defines peristomal skin condition as the primary endpoint and states a scale and timeframe, yet reports no outcome data for any measure.
The record also makes enrollment and study status central to interpretation. It reports 3 participants enrolled, a TERMINATED status, and stopping due to inability to enroll. These details explain why the intended performance question remains unanswered in the posted results. They do not reveal whether the barrier had a particular effect, and they do not provide a basis for judging precision.
Statistically, the single-group design is another important feature. A single-group evaluation can be useful for preliminary description when observations are collected, but it does not provide a randomized comparison. This record has neither a separate comparator nor reported primary outcome observations. Those limitations are complementary: the lack of a comparator constrains causal interpretation, while the lack of outcome data prevents even a descriptive estimate of the primary measure.
The safety counts also show why numbers need their context. The record lists no participants affected in the serious or other adverse-event categories among those at risk, but the small enrolled group and absent outcome reporting leave substantial limits on interpretation. The registry does not report deaths as a count or describe further event ascertainment.
For clinical researchers and biostatisticians, the record is a useful example of separating a planned endpoint from a result, and a reported count from a precise risk estimate. The appropriate statistical reading is not to infer an effect from the study’s purpose or design, but to recognize the limits imposed by termination and absent outcomes.
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 limitation is explicit: the registry says the study stopped because of inability to enroll and that no data are available for any outcome measures. As a result, the primary endpoint cannot be summarized, and the secondary outcome, Security, has no reported result. The record does not report a mean, variability, change score, confidence interval, or analysis for either outcome.
Enrollment was 3, but the registry does not report a recruitment target or sample-size justification. It is therefore not possible to compare enrollment with a documented target or determine what precision the investigators intended. The reason for inability to enroll is not described beyond that statement, and the registry record does not provide additional recruitment details.
The single-group design has no separate comparator, and allocation is listed as NA. There is no randomized between-group estimate in the record. Masking is listed as NONE. The registry does not report whether skin scoring was performed by a blinded assessor or give other details about measurement procedures. Details of the protocol, outcome-assessment schedule, analysis plan, analysis populations, and missing-data approach are not reported in the registry record.
The primary endpoint uses a categorical scale and is described through a mean irritation score. The record does not explain how category scores would be interpreted as a mean, whether the outcome was intended to be a change from baseline, or how repeated measurements within the 1 - 30 days timeframe would be summarized. These details are not reported in the registry record.
Safety interpretation is also limited. The registry lists 0 affected for serious and other adverse events among 3 at risk in each category, but does not provide further details about event definitions, collection, or observation time. Deaths are not reported in the registry record. Taken together, the study record documents the intended evaluation and its termination, but it does not furnish evaluable results for performance or a comprehensive statistical assessment of safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Preliminary Evaluation of CASTLE Barrier Prototype UK — NCT01530087.
- Registry record last updated 2016-03-22; status last verified 2015-09.
- Results first posted 2016-03-22.
- 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
NCT01530087 is a single-group, preliminary evaluation of the CASTLE barrier prototype for people with intestinal stomas and irritated peristomal skin. Hollister Incorporated is listed as the sponsor. The intervention is classified as a device; allocation is listed as NA, masking as NONE, and phase as NA. Enrollment was 3. The study start is recorded as 2012-01, primary completion as 2012-02, and status as TERMINATED.
The primary outcome was peristomal skin condition, described as a mean irritation score on a categorical scale ranging from 1 (normal) to 5 (eroded or heaemorrhagic dermatitis), with a timeframe of 1 - 30 days. Security is listed as a secondary outcome. The record says the study stopped due to inability to enroll and that no data are available for any outcome measures. It reports 0 participants affected by serious and other adverse events among 3 at risk in each category; deaths are not reported in the registry record. No outcome effect estimate can be drawn from these results.