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 Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation (NCT05135754), a na na study. The primary outcome is Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05135754 |
| Phase | NA |
| Condition | Stoma Ileostomy, Stoma Colostomy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 100 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Coloplast A/S |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with a newly formed intestinal stoma. The registry record identifies stoma ileostomy and stoma colostomy as conditions. It does not report further eligibility details or a more detailed description of the participants. The intended measure asks about leakage during the last 2 weeks, with assessments at Baseline (Day 0) and Final Evaluation (Week 12).
Intervention
Participants received Heylo, a supporting ostomy product, together with a support service. The registry describes an adhesive sensor layer placed underneath the baseplate. A connected transmitter evaluates information from the sensor and sends a status to smartphone software. The software uses a predefined flow to determine what information to deliver about baseplate status.
Comparator
The record describes a single-group study and does not identify a separate control group or comparator intervention. Allocation is recorded as NA. The intervention is therefore not evaluated against a like-for-like control group in this study record; the outcomes are framed around the participating group and the stated assessment timepoints.
Primary question
The primary endpoint asks how many times participants experienced stoma effluent leakage outside the baseplate, such as onto clothes or bedsheets, during the last 2 weeks. It is measured at baseline and at the final evaluation at Week 12. The record specifies a least-squares mean and a 95% confidence interval, but does not report the resulting estimates. The registered question is about reported leakage frequency; it does not, by itself, establish what caused any change or how Heylo compares with another product.
3. Trial Design
The registry describes a completed, single-group study of the Heylo supporting ostomy product and support service. The intended population is people with a newly formed stoma, including the listed conditions of stoma ileostomy and stoma colostomy. The study is recorded as having an enrollment of 100. Its phase is NA, allocation is NA, and masking is NONE. The record identifies Coloplast A/S as sponsor.
The intervention combines the Heylo device with a support service. The device is described as a sensor system placed underneath the baseplate. It continuously detects moisture and output leakage underneath the baseplate; a transmitter evaluates information and sends a status to smartphone software, which determines what information to deliver to the user. The registry does not provide further detail about the support service or the way participants used it.
The primary assessment is specified at Baseline (Day 0) and Final Evaluation (Week 12). The primary question asks participants to recall leakage events during the last 2 weeks. The record gives no separate comparator arm, and its single-group designation means the study does not offer a like-for-like control comparison. Allocation is not described beyond NA; the study is not recorded as randomized. No masking is recorded.
The study start date is 2021-11-25, the primary completion date is 2022-08-22, and the status is COMPLETED. The record does not report the recruitment process, detailed eligibility criteria, protocol deviations, or additional design details. These omissions limit the extent to which the conduct of the study can be reconstructed from the registry record alone.
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 | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| STARTED | 100 |
| Baseline (Intention to Treat Population) | 92 |
| COMPLETED | 80 |
| NOT COMPLETED | 20 |
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 | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|---|
| Participants analysed | 92 | |
| Age, Continuous | years | 49.4 (18 to 81) |
| Sex: Female, Male: Female | Participants | 49 |
| Sex: Female, Male: Male | Participants | 43 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United Kingdom | participants | 92 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks, measured over Baseline (Day 0) and Final Evaluation (Week 12).
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Number of leakages per two weeks |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the number of times with stoma effluent leakage outside the baseplate, for example onto clothes or bedsheets, within the last 2 weeks. The survey question asks participants to think back over that recall period and report how many such events they experienced. The measure is specified in units of number of leakages per two weeks and is assessed at Baseline (Day 0) and Final Evaluation (Week 12).
Leakage frequency is a direct measure of an outcome the study description identifies as a concern for people living with intestinal stomas. It records reported events rather than a general impression of product performance. The recall question gives the measure a defined subject and period, which helps clarify what participants are being asked to report. However, it remains a participant-reported count, and the registry does not report how the survey was administered or how missing responses were handled.
The registry specifies a least-squares mean and a 95% confidence interval for this continuous measure. The numerical estimates, the baseline and final values, and any estimated change are not reported in the registry record. Thus, the endpoint definition is available, but its observed results and precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives a clear description of the primary outcome question and its assessment timepoints, but it does not report numerical results for that endpoint. There is no posted least-squares mean, confidence interval, or estimated change for leakage frequency at Baseline (Day 0) and Final Evaluation (Week 12). Without those estimates, the magnitude and precision of the primary outcome cannot be described. This absence does not establish that leakage frequency stayed the same or changed; the result is not reported in the registry record.
The outcome is based on participants recalling the number of leakage events during the last 2 weeks. That is a measure of reported experience over a defined period. It is not, on its own, a direct measure of all leakage events or an explanation for why leakage occurred. The record does not say whether reported events were verified by another method, nor does it give details about survey administration.
The design is single-group, with no separate control comparison identified. Any comparison between baseline and final evaluation would describe what was observed over time among participants in this study. Without a control group, such a change could not be separated from other influences using this study design alone. The record does not provide an estimate of change in any case, and it does not report an analysis plan that would clarify how baseline and final measurements were compared.
The registry specifies a least-squares mean and a 95% confidence interval, but does not report the model used to obtain them, the covariates included, or the actual interval limits. A confidence interval is a way of expressing uncertainty around an estimate; its width helps readers judge how precisely the estimate is determined under the analysis assumptions. Since neither estimate nor interval is reported, readers cannot assess that precision. A p-value or test of the primary endpoint is also not reported in the registry record.
Safety information is recorded for the safety population. The record reports 5 participants affected by serious adverse events among 100 at risk, 20 affected by other adverse events among 100 at risk, and 0 deaths. These figures describe the recorded safety counts; they do not establish whether events were caused by the device, the support service, underlying conditions, or other factors. The registry does not provide comparative safety data from a control group.
The study status is COMPLETED, but completion status is not a substitute for outcome reporting. The registry also lists secondary outcome domains, including self-management, aspects of leakage impact, health-related quality of life, and an EQ-5D-5L visual analogue scale. Numerical findings for those outcomes are not reported in the registry record. Consequently, the available record supports a description of the intended questions and design, not a conclusion about the observed outcome pattern.
9. Statistical Methods Explained
The registry identifies the primary measure as a least-squares mean with a 95% confidence interval. It does not give the model specification, analysis population for the primary endpoint, covariates, handling of missing measurements, or numerical results. The statistical concepts below are general explanations; they should not be taken as a description of analyses that the registry record does not document.
What does a least-squares mean represent?
In general, a least-squares mean is a model-based estimate of an outcome mean. Depending on the model, it can represent a mean adjusted for included terms, rather than a simple arithmetic average of the observed values. The model and its included terms matter: they define how the estimate is calculated and what comparisons it supports. Here, the record names a least-squares mean but does not describe the model, its assumptions, or any adjustment variables. It is therefore not possible to determine from the registry record whether the reported label reflects adjustment for particular characteristics or how the estimate would be reproduced.
The measured outcome is a count of reported leakage episodes during the last 2 weeks, while the registry classifies the measure as continuous and specifies a least-squares mean. Count outcomes can have distributions that differ from the assumptions of common continuous-outcome models. In general, analysts consider whether the selected model suits the outcome and whether its assumptions are reasonable. The registry record does not explain the model choice or report diagnostic checks, so no conclusion can be drawn about those aspects of the analysis.
What does a confidence interval communicate?
In general, a confidence interval expresses uncertainty around an estimated quantity under the analysis method. A narrower interval indicates greater precision than a wider interval, while the interval's location indicates which values are compatible with the data and method. A confidence interval is not a guarantee that the true value lies within its limits, and its interpretation depends on the analysis assumptions. The registry specifies a 95% confidence interval for the primary endpoint but does not report its endpoints. Readers therefore cannot judge the estimated leakage frequency or its precision from the registry record.
A confidence interval for a mean is also not automatically an interval for individual participants' outcomes. It describes uncertainty about an estimated group quantity, not the range of responses across participants. The record does not provide the underlying distribution of reported leakage counts, so individual variation cannot be assessed.
What can be inferred from a baseline and final assessment?
The primary endpoint is assessed at Baseline (Day 0) and Final Evaluation (Week 12). In general, measurements at multiple timepoints can be used to describe change over time. The appropriate analysis depends on the design, the relationship between measurements, the distribution of the outcome, and the handling of missing observations. Although the single-group design and assessment timepoints are described, the registry record does not specify whether the primary analysis compares endpoint values directly, models within-participant change, or uses another approach. It does not report a change estimate. No paired analysis or change calculation should be assumed from the timepoints alone.
The question uses recall over the last 2 weeks at each assessment. In general, recall measures may be affected by how participants remember and interpret events. A defined recall period helps specify the question, but does not remove possible reporting error. The record does not report validation procedures or any additional method for confirming leakage events.
Why can over-dispersion matter for count outcomes?
General statistical context: over-dispersion occurs when the observed variability in count data is greater than a selected model expects. If it is not addressed where relevant, uncertainty estimates and tests can be poorly calibrated. Models for count outcomes may make different assumptions about the relationship between the mean and variability. This matters as a general consideration for a leakage count, but the registry does not report which model was used or whether over-dispersion was assessed. No statement about the suitability of the actual analysis can be made from the available description.
What do the planning assumptions mean?
The record includes sample-size assumptions for planning illustrations, not as a report of the trial's design justification. Those illustrations are described as based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For time-to-event outcomes, the stated convention is total events; for other outcomes, it is participants per arm. The study itself is recorded as single-group, so the assumed equal allocation between two arms is part of the planning illustration rather than a description of the observed design.
Such illustrations are hypothetical planning calculations. They are not observed power, do not show that a planned comparison occurred, and do not provide missing primary endpoint estimates. The actual numerical planning outputs are not stated in the registry record. The record does not report the trial's own sample-size justification, or establish that those planning assumptions were used to design the study. Any interpretation of a calculated planning scenario must be kept separate from what was observed in this completed single-group study.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies 7 outcome measures and 7 analyses. It names secondary outcomes covering patient self-management, domains of the Ostomy Leakage Impact Tool, health-related quality of life, and the EQ-5D-5L visual analogue scale. Numerical results for those outcomes are not reported in the registry record. The record does not describe a hierarchy among outcomes, identify which secondary analyses were confirmatory, or explain whether any adjustment was made for multiple testing.
In general, examining multiple outcomes can increase the chance that at least one result appears notable by chance when each is assessed separately. Statistical approaches to multiplicity can control that risk, but the choice depends on the analysis plan and the role of each outcome. The registry record does not report a multiplicity strategy, so it is not possible to determine whether results were adjusted or how findings across the outcome set should be interpreted together.
The record also does not report how missing data were handled, whether all enrolled participants contributed primary endpoint measurements, or which analysis population was used for the primary result. The safety information identifies a safety population, but the record does not describe the analysis population for efficacy outcomes. Baseline characteristics, participant flow, withdrawals, and reasons for missing observations are not reported in the material available in the registry record.
These details matter because missingness and analysis-set definitions can affect which observations contribute to an estimate and how representative that estimate is of the enrolled group. Without a stated method, readers should not assume that missing outcomes were excluded, imputed, or handled in any particular way. Nor should the listed number of analyses be taken as evidence that a particular statistical plan was prespecified. The registry record does not report such a plan.
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 |
|---|---|---|---|
| Safety Population | 5 | 100 | 5.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Safety Population | 0 of 100 |
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 |
|---|---|
| Safety Population | 20 of 100 |
Most frequent serious adverse event terms
| Event term | Organ system | Safety Population |
|---|---|---|
| Patient was admitted into the hospital for subarachnoid hemorrhage and encephalitis | Nervous system disorders | 1 of 100 |
| Low Neutrophils | Blood and lymphatic system disorders | 1 of 100 |
| Bleeding Stoma | Gastrointestinal disorders | 1 of 100 |
| Dehydration | Metabolism and nutrition disorders | 1 of 100 |
| Diarrhoea | Gastrointestinal disorders | 1 of 100 |
| Vomiting | Gastrointestinal disorders | 1 of 100 |
| Admitted to hospital as a result for producing high output black stoma contents | Gastrointestinal disorders | 1 of 100 |
| Abdominal pain | Gastrointestinal disorders | 1 of 100 |
| Intestinal Blockage | Gastrointestinal disorders | 1 of 100 |
| Intestinal infection | Gastrointestinal disorders | 1 of 100 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Safety Population |
|---|---|---|
| Skin redness and irritation | Skin and subcutaneous tissue disorders | 18 of 100 |
| Headache | Nervous system disorders | 6 of 100 |
Serious events with the highest arm-level rate: patient was admitted into the hospital for subarachnoid hemorrhage and encephalitis (1.0%), low neutrophils (1.0%), bleeding stoma (1.0%), dehydration (1.0%), diarrhoea (1.0%).
The registry reports safety information for a safety population. Serious adverse events affected 5 among 100 at risk. Other adverse events affected 20 among 100 at risk. The reported number of deaths is 0. These are recorded counts in the study population, not comparisons between treatment groups; the study is described as single-group and no separate control group is identified.
The listed serious-event terms are patient was admitted into the hospital for subarachnoid hemorrhage and encephalitis, low neutrophils, bleeding stoma, dehydration, diarrhoea, and vomiting. Each term is listed at 1.0%. The record does not provide further detail about severity, timing, duration, outcome, or relatedness to Heylo or the support service. The terms and percentages should not be treated as evidence of causation. The registry record does not report an assessment attributing the events to the intervention.
Counts at risk describe the denominator recorded for these safety outcomes; they do not establish how long each participant was observed or whether follow-up was complete. The record does not give comparative safety data, and the counts alone cannot distinguish events associated with the device or service from those arising for other reasons. Safety results should therefore be read as descriptive registry counts within the recorded safety population, rather than as estimates of relative risk or evidence of a causal relationship.
12. What the Result Does, and Does Not, Mean
The study addresses a practical, participant-reported question: how often stoma effluent leakage occurred outside the baseplate during the last 2 weeks. It evaluates Heylo, a sensor-based supporting ostomy product, together with a support service in a population described as having newly formed stomas. The registry specifies baseline and final assessment timepoints and identifies the primary outcome summary as a least-squares mean with a 95% confidence interval.
However, the numerical primary outcome results are not reported in the registry record. The record therefore does not show the observed leakage frequency at either assessment, an estimated change, or the precision of an estimate. It cannot establish from the posted results whether reported leakage became more frequent, less frequent, or remained similar. The absence of a reported estimate is not evidence that there was no change.
The study's single-group design also limits what a change over time could establish. Without a separate control comparison, changes during the study cannot be attributed to the device or service on the basis of this design alone. Other influences could contribute to changes in reported experience, and the registry record does not report an analysis that would separate them. The findings, if reported elsewhere, would need to be interpreted in light of this design and the study's population and measurement approach.
The safety record gives descriptive counts, including serious adverse events, other adverse events, and deaths. It does not establish that events were caused by the intervention, and it offers no comparison with a control group. Secondary outcome domains are named, but their numerical findings are not reported in the registry record. Overall, the registry supports an account of the question, intervention, design, and recorded safety counts, but not a conclusion about the primary outcome's observed effect or comparative benefit.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a clearly specified outcome and a reported outcome result. The registry states what participants were asked about, the recall period, the assessment timepoints, and the summary measure. Yet without the numerical estimates and confidence interval, readers cannot evaluate the magnitude or precision of the primary endpoint. A defined estimand and a reported estimate answer different questions; the registry gives the former more clearly than the latter.
The design is also important to interpretation. The record identifies a single-group study and no like-for-like control comparison. A before-and-after description can characterize outcomes at the specified assessments, but it does not by itself isolate the effect of the product and support service from other influences over time. This distinction is central when translating a change in a participant-reported measure into a causal claim.
The endpoint is a count recalled by participants over the last 2 weeks. That makes the measure directly relevant to the experience being studied, while also making interpretation dependent on the way participants remember and report events. The registry specifies a least-squares mean, but does not document the statistical model or its assumptions. For a count outcome, the model choice and treatment of variability are relevant considerations; the record does not provide enough detail to assess them.
Finally, the registry lists multiple outcome measures and analyses without reporting a multiplicity strategy or detailed missing-data methods. These omissions do not prove that such procedures were absent from the study conduct, but they are not documented in the registry record. Together, missing outcome estimates and limited analysis detail constrain independent statistical interpretation. The record remains useful for identifying the intended question and design, while also illustrating why transparent results and methods are necessary for assessing evidence.
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 interpreting this study record is that numerical results for the primary endpoint are not reported. Although the measure, unit, assessment timepoints, least-squares mean, and 95% confidence interval are specified, the estimates and interval limits are absent. The registry record also does not report numerical findings for the named secondary outcome domains. The completed status therefore does not make the outcome evidence assessable from this record.
The single-group design has no separate control arm, so the study does not supply a like-for-like comparison. Even if baseline and final results were available, a change over time would not by itself isolate an intervention effect. Allocation is recorded as NA, and the record identifies the study as non-randomized. No inference about comparative effectiveness can be drawn from the design described.
The primary measure relies on participant recall of leakage events during the last 2 weeks. The registry does not report details about survey administration, validation, event verification, or how changes in recall might have been considered. These omissions make it difficult to assess measurement quality beyond the wording and timeframe of the question.
Important analysis details are also not reported: the primary endpoint model, covariates, analysis population, missing-data handling, multiplicity approach, and details of the analysis plan. The record does not describe participant flow or explain whether outcome follow-up was complete. These gaps do not establish that the methods were inadequate; they mean the registry record does not permit readers to evaluate those methods. The sample-size assumptions are described as planning illustrations based on an observed effect and do not document the study's own design rationale.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation — NCT05135754.
- Registry record last updated 2024-08-21; status last verified 2024-04.
- Results first posted 2024-08-21.
- 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
The registry record describes a completed, single-group evaluation of Heylo, a supporting ostomy product, used with a support service in people with newly formed stomas. The primary question concerns the number of leakage events outside the baseplate during the last 2 weeks, assessed at Baseline (Day 0) and Final Evaluation (Week 12). The specified summary is a least-squares mean with a 95% confidence interval.
Primary and secondary numerical outcome results are not reported in the registry record. The study has no separate control comparison, and the statistical model, missing-data methods, multiplicity approach, and primary analysis population are not described. Safety information reports serious adverse events affecting 5 among 100 at risk, other adverse events affecting 20 among 100 at risk, and 0 deaths. These are descriptive counts and do not establish causation. The record identifies the study as COMPLETED, with start date 2021-11-25 and primary completion date 2022-08-22.