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 Heylo, a Novel App Driven Digital Supporting Ostomy Product (NCT05200416), a randomized na study. The primary outcome is Emotional Impact Score (Scale From 0-100).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05200416 |
| Phase | NA |
| Condition | Ileostomy - Stoma, Colostomy Stoma |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 144 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Coloplast A/S |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with intestinal stomas, including ileostomy and colostomy stomas. The registry describes the primary analysis population as randomized participants with valid informed consent who had used at least one product and had information on at least one endpoint.
Intervention
The test product was Heylo, an app-driven supporting ostomy product. Its sensor layer is placed underneath the baseplate and detects moisture and output leakage; a connected transmitter sends information to a smartphone application, which delivers status information according to a predefined flow.
Comparator
The comparator was Standard of Care. The investigation used a randomized crossover design, so the comparison concerned the products within the trial’s crossover framework. Details of the period sequence beyond the reported Heylo-to-Standard-of-Care sequence are not reported in the registry record.
Primary question
The primary question was whether Emotional Impact Score, measured using the OLI scale at the end of each test period, differed between Heylo and Standard of Care over the stated timeframe of 8 weeks. The score ranges from 0-100; higher scores represent less emotional impact. The registry reports a mixed-model comparison of final values.
The clinical context described in the registry is that leakage can affect quality of life for people living with intestinal stomas. Heylo is intended to provide information about moisture and output leakage underneath the baseplate. The endpoint therefore addresses emotional impact rather than directly reporting leakage frequency or another measure of product performance. Whether the reported score difference corresponds to a meaningful change for participants is not established by the numerical comparison alone; a threshold for clinical importance is not reported in the registry record.
3. Trial Design
This was a randomized, unmasked crossover trial comparing Heylo with Standard of Care. The registry lists the study as completed, with enrollment of 144. The study began on 2022-01-13 and primary completion was recorded on 2022-11-04. The registry lists the phase as NA.
In a crossover study, participants receive more than one intervention during the investigation, allowing outcomes under different products to be compared within the trial’s design. General explanation: within-participant comparisons can account for stable characteristics shared across a participant’s treatment periods, but interpretation can also depend on period effects, treatment sequence, and whether effects carry over between periods. The registry record does not report details of any washout, the sequence allocation procedures, or how period and carryover effects were handled.
Randomization was used, but masking was listed as none. Participants and study personnel therefore were not described as masked in the registry. Lack of masking can matter for questionnaire-based outcomes because participants know which product they are using; the direction or size of any resulting influence cannot be determined from the registry results.
The primary outcome was Emotional Impact Score on the OLI scale, evaluated at the end of each test period. The stated timeframe was 8 weeks. The primary analysis population was described as an intention-to-treat population, also called the full analysis set, comprising randomized participants with valid informed consent who had been exposed to at least one product and had information on at least one endpoint. For the reported Heylo-to-Standard-of-Care sequence, the record states that 68 were analyzed and 4 were excluded from analysis.
The registry lists Participation in Society Domain Score as a secondary outcome. Details of the statistical analysis plan, including how the crossover structure was represented in the model, are not reported in the registry record. The available description identifies the sponsor’s method as a mixed models analysis, but does not provide model specifications.
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.
First Intervention (8 Weeks ± 3 Days)
| Stage | Test Product - Heylo First, Then Standard of Care | Standard of Care First, Then Test Product - Heylo |
|---|---|---|
| STARTED | 72 | 72 |
| Received Allocated Intervention | 71 | 72 |
| COMPLETED | 68 | 66 |
| NOT COMPLETED | 4 | 6 |
Second Intervention (8 Weeks ± 3 Days)
| Stage | Test Product - Heylo First, Then Standard of Care | Standard of Care First, Then Test Product - Heylo |
|---|---|---|
| STARTED | 68 | 66 |
| COMPLETED | 66 | 58 |
| NOT COMPLETED | 2 | 8 |
Analysis population for the primary outcome, as defined in the registry: The intention-to-treat (ITT) population (full analysis set) was constituted of all randomized subjects with valid informed consent who had been exposed to at least one product, and with information on at least one endpoint. Heylo --\> Standard of Care: Analyzed (n=68) / Excluded from analysis (n=4) (Reasons: Only baseline data (n=4)). Standard of Care --\> Heylo: Analyzed (n=71) / Excluded from analysis (n=1) (Reason: Only baseline data (n=1)).
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: Due to the cross-over study design, all participants were randomized to receive all interventions. Baseline data has therefore been reported for all 'All Study Participants' (Intention-to-Treat Population). Intention-to-Treat Population included randomized participants who had been exposed to at least 1 product and with information on at least 1 endpoint (n=139). n=5 randomized participants only reported baseline data, and were not included in the ITT-Population.
| Characteristic | Unit | All Study Participants |
|---|---|---|
| Participants analysed | 139 | |
| Age, Continuous | years | 50.7 (SD 13.5) |
| Sex: Female, Male: Female | Participants | 71 |
| Sex: Female, Male: Male | Participants | 68 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Germany | participants | 139 |
6. Primary Endpoint
The registry lists the primary outcome as Emotional Impact Score (Scale From 0-100), measured over 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was Emotional Impact Score, measured with the validated OLI scale at the end of each test period. The questionnaire contains 10 questions, with response options of All of the time, Often, Sometimes, and Rarely or never. Responses can be converted into a combined numerical score ranging from 0-100. A score of 100 represents no impact, while a score of 0 represents full impact.
This endpoint captures the emotional impact associated with living with a stoma, rather than directly counting leakage events or measuring the sensor’s detection accuracy. It is relevant to the investigation’s stated concern that leakage can negatively influence quality of life. Its scale direction is important: a higher value indicates less emotional impact, so interpretation of a difference must take that direction into account.
The registry reports least-squares means for the product groups and a mixed-model mean difference in final values. Least-squares means are model-based estimates rather than necessarily raw arithmetic averages. The model specification and the clinical threshold for an important difference are not reported in the registry record. Although the scale is identified as validated, details about validation in this particular study population are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The reported least-squares mean for Heylo was 73.4, with a 95% confidence interval from 68.9 to 77.9. For Standard of Care, the reported least-squares mean was 62.0, with a 95% confidence interval from 57.6 to 66.4. Because higher Emotional Impact Scores indicate less impact, the direction of the posted estimates favors a higher score under Heylo. These are model-based endpoint estimates, not a direct summary of every participant’s experience.
The sponsor’s mixed models analysis reported a mean difference in final values of 11.42, with a 95% confidence interval from 7.83 to 15.01 and p < 0.001. The interval is entirely above zero and the reported p-value indicates evidence against a zero difference under the analysis used. Statistical evidence of a difference does not by itself establish its clinical importance. A threshold for interpreting the size of a meaningful change is not reported in the registry record.
General explanation: a confidence interval describes the uncertainty around an estimate under the statistical model and its assumptions. A narrower interval indicates more precision than a wider interval, but an interval does not show the range of individual participant outcomes. The reported intervals concern estimated group scores and the model-based contrast, not a guarantee that the true effect lies within a fixed range.
The record lists 139 participants for each product estimate. It also records enrollment of 144 and, for the stated Heylo-to-Standard-of-Care sequence, 68 analyzed and 4 excluded from analysis. These figures refer to different registry entries and analysis descriptions; the record does not explain all differences between them. In a crossover trial, the product estimates should not be interpreted as independent parallel groups without considering the model and the trial structure.
The result concerns the Emotional Impact Score at the stated endpoint and timeframe. It does not establish how the score changed over time, whether a participant-level improvement occurred, or whether the difference was caused solely by the product. The registry record does not report detailed period effects, sequence effects, carryover assessment, or the model’s covariates. Those omissions limit independent assessment of how the crossover features were handled. The result should therefore be read as the sponsor’s reported model-based comparison, with its stated precision, rather than as a complete account of every outcome or mechanism.
9. Statistical Methods Explained
What does the mixed-model result describe?
The registry identifies the primary endpoint estimates as least-squares means and the sponsor’s analysis as a Mixed Models Analysis. It reports a mean difference in final values of 11.42, with a 95% confidence interval from 7.83 to 15.01 and p < 0.001. The estimate is expressed on the Emotional Impact Score scale, where higher scores represent less impact. The reported comparison is model-based; it should not automatically be treated as a simple subtraction of the displayed least-squares means.
General explanation: mixed models can represent relationships among observations that are not independent, such as repeated measurements from the same participant. Depending on their specification, they can also include explanatory terms for features of the study design. The registry record does not report the fitted model formula, covariance structure, covariates, or details of how the crossover periods were represented. It is therefore not possible to assess those choices from the record alone.
How should the confidence interval and p-value be read?
The 95% confidence interval for the reported contrast ranges from 7.83 to 15.01. General explanation: a confidence interval communicates the uncertainty associated with an estimate under the model and assumptions used. It is not an interval containing 95% of individual participants’ scores, and it does not describe the spread of participant-level responses. The registry also reports p < 0.001. General explanation: a p-value describes how compatible the observed data are with a specified null hypothesis under the analysis assumptions; it is not the probability that the null hypothesis is true, nor a measure of clinical importance.
The interval is entirely on the positive side of zero, consistent with the reported positive mean difference. Since the score is oriented so that higher values represent no impact, this direction corresponds to a higher estimated score for Heylo than for Standard of Care. The result does not, by itself, say how many participants had a better score or how large individual changes were.
Why does the crossover structure matter?
General explanation: crossover designs collect outcomes under multiple interventions within the same trial participant. This can make within-participant information useful, but outcomes can also depend on the period in which a product is used, the order in which products are received, or lingering effects from an earlier period. Sound analysis generally needs to address the design features relevant to the study. The registry identifies a crossover model and reports a mixed-model analysis, but period, sequence, and carryover handling are not reported in the registry record. No assumptions about those methods can be verified from the posted description.
The record is unmasked. General explanation: knowledge of the intervention can influence questionnaire responses or other behaviors, especially for subjective outcomes. This is a potential source of bias, not proof that bias occurred. The registry does not report procedures that would quantify or rule out such influence.
What do the analysis population entries mean?
The primary population is described as an intention-to-treat population or full analysis set, defined as randomized participants with valid informed consent who were exposed to at least one product and had information on at least one endpoint. This definition includes exposure and endpoint-information conditions, so it is not simply a statement that every randomized participant was included in every analysis. For the Heylo-to-Standard-of-Care sequence, 68 were analyzed and 4 were excluded from analysis. Reasons for those exclusions and the handling of missing endpoint values are not reported in the registry record.
General explanation: missing-data methods can affect estimates when participants do not provide all planned observations. The registry does not specify whether missing values were imputed, how incomplete crossover observations were handled, or whether sensitivity analyses assessed the impact of missingness. The reported estimates should be understood with that uncertainty in mind.
What does the planning illustration represent?
General explanation: sample-size planning translates an assumed effect and statistical model into an illustrative amount of information needed for a future study. The planning assumptions described for this investigation use a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such illustrations are planning scenarios, not observed power, and do not establish the design rationale for the completed trial. The trial’s own sample-size justification and design calculations are not reported in the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Mixed Models Analysis | Mean Difference (Final Values) 11.42 | 7.83 to 15.01 | < 0.001 |
The registry reports the sponsor’s primary comparison as a Mixed Models Analysis of final values. The reported mean difference was 11.42, with a 95% confidence interval from 7.83 to 15.01 and p < 0.001. The registry does not flag a discrepancy between the sponsor result and a recalculated result. No separate recalculated contrast is reported in the registry record for this endpoint.
The model-based result should therefore be read as the posted sponsor analysis, rather than replaced by a calculation from the displayed group estimates. The record also gives least-squares means of 73.4 for Heylo and 62.0 for Standard of Care, with corresponding 95% confidence intervals from 68.9 to 77.9 and from 57.6 to 66.4. These estimates help describe the endpoint scale, but do not disclose the model details needed to reproduce the contrast independently.
The analysis is identified as a mixed-model comparison, but the registry does not report its full specification, including how the crossover periods and any within-participant correlation were handled. The result can be interpreted in the direction of higher Emotional Impact Score under Heylo, with higher scores indicating less impact, while recognizing that the clinical importance of the difference and the adequacy of unreported modeling choices cannot be established from the registry record.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists the Emotional Impact Score as the primary outcome and Participation in Society Domain Score (Scale From 0-100) as a secondary outcome. It reports 2 outcome measures and 2 analyses. The secondary outcome’s result is not reported in the registry record. The record does not describe a multiplicity adjustment, a hierarchy for testing outcomes, or whether the primary comparison was the only confirmatory hypothesis. As a result, the reported p-value should be understood as the value attached to the stated sponsor analysis; the record does not establish how it should be interpreted across a family of outcomes or analyses.
The primary analysis population is described as the intention-to-treat population, or full analysis set: randomized participants with valid informed consent, exposure to at least one product, and information on at least one endpoint. For the Heylo-to-Standard-of-Care sequence, the record states that 68 were analyzed and 4 were excluded from analysis. The reasons for exclusion, the exact completeness requirements for the primary endpoint, and whether the analysis population differed for other outcomes are not reported in the registry record.
General explanation: missing outcome data can affect both precision and the possibility of bias, depending on why observations are absent and how the analysis handles them. The registry does not report the amount or pattern of missing primary endpoint data beyond the sequence-specific analysis and exclusion figures. Imputation methods, assumptions about missingness, and sensitivity analyses are also not reported in the registry record. It is therefore not possible to assess whether the estimates would change under alternative approaches to incomplete observations.
The distinction between enrollment, analysis entries, and product-specific estimates matters in a crossover study. Enrollment was recorded as 144, while the arm entries list 139 for each product estimate. The registry does not explain the relationship between these figures in detail. Because participants can contribute information under more than one product in a crossover design, the product entries should not be added to infer a count of unique participants. The available record supports describing the entries as posted, but not reconstructing a complete participant flow.
12. 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 |
|---|---|---|---|
| Test Product - Heylo | 3 | 144 | 2.1% |
| Standard of Care | 4 | 144 | 2.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test Product - Heylo | 1 of 144 |
| Standard of Care | 2 of 144 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Test Product - Heylo | 5 of 144 |
| Standard of Care | 0 of 144 |
Most frequent serious adverse event terms
| Event term | Organ system | Test Product - Heylo | Standard of Care |
|---|---|---|---|
| Morbus Crohn boost / new stoma | Surgical and medical procedures | 0 of 144 | 1 of 144 |
| Peritonitis | Surgical and medical procedures | 0 of 144 | 1 of 144 |
| Dysfunction of the gall bladder | Hepatobiliary disorders | 1 of 144 | 0 of 144 |
| Pneumonia | Infections and infestations | 1 of 144 | 0 of 144 |
| Prolapse | Surgical and medical procedures | 0 of 144 | 1 of 144 |
| Thyroid Surgery | Surgical and medical procedures | 1 of 144 | 0 of 144 |
| Early stoma re-operation | Surgical and medical procedures | 1 of 144 | 0 of 144 |
| Morbus Crohn boost | Surgical and medical procedures | 0 of 144 | 1 of 144 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Test Product - Heylo | Standard of Care |
|---|---|---|---|
| Skin redness and irritation | Skin and subcutaneous tissue disorders | 5 of 144 | 0 of 144 |
Serious events with the highest arm-level rate: morbus crohn boost / new stoma (0.7%), peritonitis (0.7%), dysfunction of the gall bladder (0.7%), pneumonia (0.7%), prolapse (0.7%).
The adverse-event entries list serious adverse events for 3 participants in the Heylo group and 4 in the Standard of Care group; each group has 144 at risk. Other adverse events are listed for 5 in the Heylo group and 0 in the Standard of Care group, with 144 at risk in each group. Deaths are recorded as 1 in the Heylo group and 2 in the Standard of Care group.
The registry lists Morbus Crohn boost / new stoma, Peritonitis, Dysfunction of the gall bladder, Pneumonia, Prolapse, and Thyroid Surgery among the top serious-event terms, each with 0.7%. These terms are listed without an event-group attribution in the record, so they should not be assigned to a particular product group based on these entries alone.
General explanation: adverse-event counts describe events recorded under the registry’s reporting definitions; they do not establish that an intervention caused an event. The entries do not provide enough information to assess timing, seriousness criteria, relatedness, or participant-level overlap. In a crossover study, group labels and at-risk entries should not be treated as independent populations without details of the safety reporting approach. Causal interpretation, comparative risk estimates, and a judgment about whether the observed counts indicate a product-related effect are not established by these figures.
13. What the Result Does, and Does Not, Mean
The posted primary result is a positive model-based difference in Emotional Impact Score for Heylo compared with Standard of Care: 11.42, with a 95% confidence interval from 7.83 to 15.01 and p < 0.001. The estimated score for Heylo was 73.4, compared with 62.0 for Standard of Care. The scale runs from 0-100, with higher scores indicating less emotional impact. These statistics describe the registry’s reported endpoint comparison at the end of each test period.
They do not show the distribution of individual participant scores or establish how many participants experienced a change. They also do not determine whether the difference is large enough to be important to participants, because a threshold for clinical importance is not reported in the registry record. The endpoint measures emotional impact; it is not itself a direct measure of leakage frequency, sensor performance, or every aspect of quality of life.
The result also does not prove that the product alone caused the difference. The study was unmasked, and the registry does not report the full model specification or how period, sequence, and carryover effects were addressed. These considerations are relevant to interpretation, but the registry does not quantify their influence.
The reported safety entries should be read as recorded event counts, not as evidence of causation. The registry does not establish whether events were related to the products, nor does it give enough detail to derive a causal safety comparison. The result is therefore best understood as a specific statistical finding about the primary score, alongside limits in the available design and reporting detail. It does not resolve questions about other outcomes, longer-term effects, or applicability beyond the study population described in the record.
14. Why This Trial Matters Statistically
This trial is statistically interesting because its crossover design compares Heylo with Standard of Care within a randomized investigation, while the primary outcome is a participant-reported score. That combination makes the way repeated observations and treatment periods are handled important. The registry reports a mixed-model analysis, which is appropriate to identify as the sponsor’s stated analytical approach, but does not disclose enough model detail to independently assess how the crossover structure was represented.
The result also illustrates why scale direction matters. Emotional Impact Score ranges from 0-100, with 100 meaning no impact and 0 representing full impact. A higher score therefore indicates less emotional impact. Without understanding this orientation, a positive difference could be misread. The confidence interval and p-value describe statistical uncertainty and evidence under the stated analysis; they do not establish the practical importance of the score difference.
Unmasked assessment is another relevant feature because the primary outcome is a questionnaire score. General explanation: participant knowledge of the intervention can influence subjective reporting, although the registry information does not establish whether that occurred in this trial. The effect of unmasking cannot be quantified from the posted result.
Finally, the record illustrates the distinction between a statistically clear estimate and a fully documented analysis. The sponsor’s comparison is reported with a confidence interval and p-value, but the record does not describe missing-data methods, multiplicity handling, model details, or a clinical-importance threshold. Those omissions do not erase the reported result; they define the boundaries of what can be concluded from the registry record.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry identifies a randomized, unmasked crossover design but does not report the full treatment sequence schedule, whether a washout was used, or how period and carryover effects were assessed. Those details are relevant to interpreting within-participant comparisons. The mixed-model method is named, but its specification, covariates, correlation structure, and handling of period effects are not reported in the registry record.
The posted primary endpoint is a questionnaire-based emotional-impact score. The record gives its scale direction and response options, but does not state a threshold for a clinically important difference or provide participant-level outcome distributions. The reported least-squares means and contrast therefore do not establish the range of individual experiences or the importance of the estimated difference to participants.
The registry says masking was none. It does not describe procedures to assess the possible influence of intervention awareness on questionnaire responses. The analysis population definition includes requirements for exposure and endpoint information, and the Heylo-to-Standard-of-Care sequence entry reports 68 analyzed and 4 excluded. Reasons for exclusion and detailed missing-data methods are not reported in the registry record.
The record lists a secondary outcome, Participation in Society Domain Score, but its result is not reported in the registry record. Multiplicity procedures and the broader statistical analysis plan are also not reported. Enrollment is 144, while the product estimate entries each list 139; the record does not explain this relationship in detail. Finally, adverse-event entries do not provide sufficient information on relatedness, timing, or participant-level overlap to support causal conclusions about safety.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product — NCT05200416.
- Registry record last updated 2025-01-23; status last verified 2024-12.
- Results first posted 2025-01-23.
- 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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19. Record Summary
NCT05200416 is a completed randomized, unmasked crossover investigation of Heylo compared with Standard of Care in people with intestinal stomas. Enrollment was 144. The primary endpoint was Emotional Impact Score on the OLI scale, measured at the end of each test period over the stated timeframe of 8 weeks. Higher scores indicate less emotional impact.
The sponsor’s mixed-model analysis reported a mean difference in final values of 11.42, with a 95% confidence interval from 7.83 to 15.01 and p < 0.001. The registry also reports least-squares means of 73.4 for Heylo and 62.0 for Standard of Care. The record lists Participation in Society Domain Score as a secondary outcome, but its result is not reported in the registry record.
Important interpretation details—including the complete model specification, missing-data methods, multiplicity handling, and assessment of crossover period or carryover effects—are not reported in the registry record. The posted estimates describe the primary score comparison but do not establish clinical importance or causation.