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 Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly (NCT06831513), a na na study. The primary outcome is Change in Cranial Measurements as Measured by CVA.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06831513 |
| Phase | NA |
| Condition | Plagiocephaly, Nonsynostotic |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Infants with plagiocephaly, nonsynostotic. The registry record lists 18 participants enrolled; further eligibility details are not reported in the registry record.
Intervention
The Serkel 3D cranial remolding orthosis, a custom-made helmet. The record describes scanning an infant’s head, fabricating the orthosis, and fitting it two weeks later. It characterizes the device as nearly identical to existing FDA-approved devices.
Comparator
There is no comparison group. The study is listed as a single-group study, with no randomized allocation. Its results therefore cannot provide a like-for-like comparison against another treatment or a control group.
Primary question
How does cranial vault asymmetry (CVA), measured in millimeters, change from baseline to the end of treatment, described as approximately 4-6 months? The registry record gives the measurement plan but does not report the observed change.
The study is titled as an observation of the effects of the Serkel cranial remolding orthosis in infants with deformational plagiocephaly. Its stated purpose is to assess the safety and effectiveness of a particular orthosis that is new to the United States market. The primary outcome is a change in a skull-shape measurement, rather than a comparison between assigned treatment groups.
That distinction matters for the question the study can answer. A before-and-after measurement can describe how CVA changes among enrolled infants who are measured over treatment. Without a comparator group, however, the study design cannot separate changes occurring during treatment from changes that might occur over time for other reasons. The registry record does not report the outcome values needed to describe the observed change, and it does not report a statistical analysis of that outcome.
3. Trial Design
This is a completed, single-group pilot study sponsored by the University of Texas Southwestern Medical Center. The registry record lists 18 participants enrolled and the Serkel 3D CRO as the device intervention. The study began on 2022-05-24, reached primary completion on 2024-04-05, and is listed as completed. Its phase is recorded as not applicable.
The design has no randomized allocation and no masking. A single group receives the device; there is no control arm described. The record’s description says parents or caregivers decide whether to consent for their child to participate and be treated. It then describes scanning the infant’s head, fabricating the orthosis, and fitting it two weeks later. This is not a randomized comparison, and there is no like-for-like control group against which to estimate a treatment contrast.
The primary measurement is planned at baseline and at the end of treatment, described as approximately 4-6 months. The description also says measurements are taken at each appointment. It allows measurement by hand with a tape measure and calipers or by an FDA-approved scanner, naming the OMEGA Scanner 3D and Orthomerica STARscanner. Which method was used for each participant, and how measurement methods were selected or harmonized, are not reported in the registry record.
The registry record lists two outcome measures and zero analyses. It does not report a protocol, a sample-size justification for the enrolled group, or a statistical analysis plan. The enrollment count is a description of study size, not evidence that the study had adequate precision to detect a particular change.
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: 19 subjects consented but 1 screen failed and did not start treatment with the device. Therefore, only 18 considered enrolled and started treatment.
Overall Study
| Stage | Serkel 3D CRO Arm |
|---|---|
| STARTED | 18 |
| COMPLETED | 18 |
| NOT COMPLETED | 0 |
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 | Serkel 3D CRO Arm |
|---|---|---|
| Participants analysed | 18 | |
| Age, Categorical: <=18 years | Participants | 18 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | weeks | 30.4 (16 to 54) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 14 |
| Race/Ethnicity, Customized: Hispanic | Participants | 10 |
| Race/Ethnicity, Customized: Asian | Participants | 1 |
| Race/Ethnicity, Customized: Caucasian | Participants | 6 |
| Race/Ethnicity, Customized: African American | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Cranial Measurements as Measured by CVA, measured over Baseline, approximately 4-6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | mm |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in cranial vault asymmetry (CVA), measured in millimeters. CVA is defined as the difference between the lengths of two diagonals across the top of the skull. The diagonals are measured at a 30-degree angle from the midline; the longer diagonal is labeled A and the shorter diagonal B, and CVA is calculated as A minus B. The registry record describes measurements at baseline and at the end of treatment, approximately 4-6 months.
CVA is used as a measure of asymmetry in skull shape: it expresses the difference between the two diagonal lengths as a single measurement. Repeating the measurement over time allows a within-participant description of how that difference changes. The registry record says measurements may be made by hand with a tape measure and calipers or with one of two named scanners, and that measurements are taken at each attended appointment.
The endpoint is listed with a mean parameter and full-range dispersion. The record does not provide the baseline or follow-up values, the observed mean change, the range, or a confidence interval. It also does not specify the exact endpoint analysis or how measurements from different methods or visits would be handled. Thus the outcome definition is described, but the amount and precision of any observed change are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the study as completed and lists 18 participants enrolled, but it does not report numerical results for the primary CVA outcome. In particular, it does not give baseline measurements, end-of-treatment measurements, a mean change, the full range, or an estimate of uncertainty. It also lists zero analyses. Consequently, the posted information does not establish the direction, size, or precision of the observed CVA change.
The endpoint description is useful for understanding what investigators intended to measure: the difference between two diagonal skull lengths, in millimeters, at baseline and around the end of treatment. But a measurement definition is not an outcome result. Without the actual measurements or a reported summary, readers cannot tell how much CVA changed in this group or whether participants had similar or widely varying changes.
The study’s single-group design also limits interpretation even if before-and-after results were available. A change observed within one group would describe what happened over time among participants in that group; it would not, by itself, show what would have happened over the same period without the device or under another approach. There is no randomized comparator, and no allocation-based treatment contrast is reported.
The registry lists 18 participants enrolled, but that number alone does not establish how many contributed paired endpoint measurements. The number with baseline and end-of-treatment measurements, any exclusions from outcome analyses, and the handling of incomplete follow-up are not reported in the registry record. Therefore, the enrollment figure should not be treated as the denominator for the primary outcome without additional reporting.
The record’s safety counts list 18 participants at risk and zero affected by serious adverse events, zero affected by other adverse events, and zero deaths. These are the posted counts; they do not establish that no unrecorded or unreported events occurred. The record does not provide event terms, follow-up-specific safety denominators, or further detail on ascertainment.
A planning illustration based on an observed effect is described in the study information, but no numerical planning results are present in the record summarized for this analysis. Such an illustration would not be observed power and would not substitute for reported endpoint estimates. No conclusion about statistical significance, clinical importance, or comparative effectiveness can be drawn from the outcome information listed in the registry record.
9. Statistical Methods Explained
The registry record describes a continuous measurement collected over time in one group. It lists the primary outcome parameter as a mean and its dispersion as a full range. However, it reports no outcome analysis results and identifies zero analyses. The methods below explain how such data are generally interpreted; they should not be read as a description of analyses actually performed in this study.
What does a before-and-after endpoint estimate?
General statistical context: In a repeated-measure design, each participant can have a baseline value and a later value. A within-participant change is the later measurement compared with that same participant’s baseline. Summarizing these changes can describe the average change in the group, while also showing how much individual changes vary. The registry record names baseline and end-of-treatment measurements but does not state the exact calculation or analysis used for change. It does not report the paired measurements or a group estimate.
A single-group change is not the same quantity as a difference between treatment groups. It captures change over time among those observed in the group, which may reflect treatment as well as other influences on measurements or participants over time. Without a control group, the design does not provide a direct estimate of what the outcome would have been in a comparable group without the device.
What do the mean and full range describe?
General statistical context: A mean is an average that gives a concise summary of a set of measurements. A range describes the lowest and highest observed values, and therefore gives a sense of the spread from one extreme to the other. Neither summary alone shows the full shape of the data. A range can be especially sensitive to extreme observations, while a mean can be influenced by unusually high or low values. The registry record lists mean and full-range summaries, but gives no values for either.
Dispersion and uncertainty are related but distinct. A range describes observed variability in the data; a confidence interval describes uncertainty around an estimated quantity under a specified statistical method. General statistical context: a confidence interval gives a range of estimates compatible with the data and model at a stated confidence level. Its width depends on the information in the data and the analysis assumptions. No confidence interval or confidence level for the primary outcome is reported in the registry record.
How should measurement methods be considered?
The outcome description permits either hand measurement with a tape measure and calipers or measurement with an FDA-approved scanner. It names the OMEGA Scanner 3D and Orthomerica STARscanner. General statistical context: measurements can vary because of the instrument, the person measuring, participant positioning, or ordinary measurement error. If measurement methods differ across participants or visits, a clear analysis plan can help distinguish changes in the underlying measurement from changes associated with measurement procedures. The record does not report which method was used, whether methods changed across visits, or how such differences were handled.
The record says measurements are taken at every appointment, while the primary timeframe identifies baseline and approximately 4-6 months. General statistical context: repeated measurements between these time points can provide more information about the trajectory over time, but an analysis must specify which visits contribute to the primary endpoint and how measurements at different times are compared. The analysis method for intermediate appointments, if any, is not reported in the registry record.
What can be inferred from the planning illustration?
The study information describes a planning illustration based on an observed effect. Its assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it describes the target effect as a stated fraction of the observed effect. Those are assumptions for an illustrative calculation, not a description of this single-group study’s design. The record does not report the numerical illustration, the observed effect used to generate it, or a trial-specific sample-size justification.
General statistical context: planning estimates can show how a hypothetical study’s required size would depend on the effect targeted and the assumed variability. They are not observed power, do not establish that a completed study was adequately sized, and do not recover missing outcome results. Because the registry record does not report the primary outcome estimate or the numerical planning outputs, no sample-size implication can be drawn from the information listed.
The record does not report a statistical test, model, adjustment method, confidence interval, or treatment-effect estimate for the primary outcome. It therefore is not possible to identify a particular inferential method as the study’s method or to assess its assumptions from the registry entry.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures and zero analyses. It identifies change in CVA as the primary outcome, but the second outcome’s details and results are not included in the information available for this analysis. A plan for prioritizing outcomes or controlling the chance of false-positive findings across multiple comparisons is not reported in the registry record.
General statistical context: when several outcomes or analyses are tested, the chance of finding at least one apparently unusual result can increase if each is considered separately without regard to the others. A prespecified hierarchy or an adjustment can address some multiplicity concerns. No such strategy, testing sequence, or adjusted result is reported in the registry record. Because no outcome analyses are listed, there are no posted p-values or estimates to assess for multiplicity.
The record reports 18 enrolled participants, but it does not report how many had outcome measurements at each visit, how many contributed to the primary analysis, or whether participants were excluded. Missing-data rules, imputation methods, and sensitivity analyses are not reported in the registry record. The participant population used for any outcome analysis, including whether it included all enrolled participants or only those with complete measurements, is also not reported.
These omissions matter because the number enrolled does not necessarily equal the number with a usable baseline and follow-up pair. General statistical context: when follow-up measurements are missing, the resulting analysis can be less precise, and its interpretation may depend on why values are missing and how missingness is handled. The record does not provide enough detail to assess these issues or to determine whether the endpoint estimate represents all enrolled participants.
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 |
|---|---|---|---|
| Serkel 3D CRO Arm | 0 | 18 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Serkel 3D CRO Arm | 0 of 18 |
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 |
|---|---|
| Serkel 3D CRO Arm | 0 of 18 |
The adverse-event record lists 18 participants at risk in the Serkel 3D CRO group. It reports zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths. No serious adverse-event terms are listed. These are the safety counts recorded for this group; the registry record does not describe event narratives or further details of safety monitoring.
General statistical context: a count of zero recorded events is a description of what was reported, not proof that an event is impossible or that risk is absent. How informative a zero count is depends on factors such as the number observed, the duration and completeness of observation, and how events were sought and recorded. The registry record does not report a detailed safety follow-up duration, the ascertainment procedures, or additional denominators over time. It also does not state whether all participants completed the same safety observation period.
These figures should be read as registry-reported counts, not as a comparison with another device or with no device. The study has a single group and no control arm. The record therefore does not support a comparative safety estimate, and the posted counts alone do not establish the absence of unreported events.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed pilot study of the Serkel 3D cranial remolding orthosis in infants with nonsynostotic plagiocephaly. It describes the device, the planned baseline and end-of-treatment CVA measurement, and safety counts for the single group. It lists 18 participants enrolled and reports zero affected by serious adverse events, zero affected by other adverse events, and zero deaths.
The primary outcome result itself is not reported in the registry record. There is no baseline or follow-up mean, no mean change, no range, and no estimate of uncertainty. As a result, the posted information does not indicate the direction or size of CVA change, how consistent any changes were across participants, or how precisely the outcome was estimated.
Even with a reported before-and-after change, the single-group design would describe change over time rather than isolate a causal effect of the device. There is no control group or randomized comparison to help distinguish the device’s contribution from other influences. The record also does not report how many participants contributed endpoint measurements or how missing measurements were handled.
The safety counts are likewise descriptive. They record no affected participants for the listed event categories, but the record does not provide detailed ascertainment or follow-up information, and there is no comparator for a relative safety assessment. The counts should not be extended into claims about unrecorded events or other populations.
In general, a pilot study can contribute descriptive information and help identify questions for further study. The registry information does not include the outcome estimates or analyses needed to judge the magnitude or precision of the primary measurement change. It therefore supports a description of the study design and posted safety counts, not a conclusion about effectiveness or comparative benefit.
13. Why This Trial Matters Statistically
This study is statistically informative in part because its design makes the distinction between observing change and estimating a comparative effect especially important. The primary outcome is a measured change from baseline in one group. That can describe what happened among participants with measurements, but without a comparison group it cannot estimate how the same outcome would have changed under another condition.
The registry record also illustrates why endpoint definitions and results must be considered separately. It gives a specific definition of CVA, the unit of measurement, the planned measurement times, and permitted measurement approaches. Yet it does not report the numerical outcome summaries or analyses. A detailed endpoint description can clarify what investigators intended to assess, but it cannot establish the observed result or its precision.
Measurement procedures are relevant to interpretation because the record permits both hand measurements and scanner-based measurements. General statistical context: when measurement procedures vary, documentation of the methods used and how they are applied over time can help readers assess comparability and measurement error. The registry record does not report those implementation details.
The entry lists 18 participants enrolled and reports safety counts, but the enrollment count does not tell readers how many contributed complete outcome data. The absence of reported analysis populations and missing-data methods limits assessment of whether endpoint summaries, if reported elsewhere, would represent all enrolled infants.
Finally, the described planning illustration uses a hypothetical two-arm allocation despite this being a single-group study. Recognizing that distinction prevents a planning calculation from being mistaken for the study’s design or for observed power. These features make transparent reporting of outcome estimates, uncertainty, measurement procedures, and analysis populations central to interpreting the study.
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 for interpreting this registry entry is that it does not report the primary CVA outcome values or analyses. Although the endpoint and its measurement timeframe are described, there is no observed change, dispersion value, confidence interval, or statistical test. The magnitude and precision of any change therefore cannot be evaluated from the registry record.
The study is a single-group, nonrandomized design with no like-for-like control comparison. Any within-group change cannot, on its own, separate the influence of the device from other influences over time. The entry does not report a comparison against another device or a group receiving no device.
The outcome description allows hand measurement or scanner measurement, but the record does not state which approach was used for participants, whether the same approach was used across visits, or how measurements from different methods were handled. It also does not report the number of participants with paired baseline and end-of-treatment measurements. Missing-data handling and analysis-population definitions are not reported in the registry record.
The registry lists two outcome measures but does not provide the second outcome’s details in the information available for this analysis, a multiplicity plan, or any outcome analyses. A trial-specific sample-size justification and numerical planning results are also not reported in the registry record. The listed enrollment and safety counts do not resolve these reporting gaps or establish precision for the primary endpoint.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly — NCT06831513.
- Registry record last updated 2025-05-16; status last verified 2025-04.
- Results first posted 2025-05-16.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, single-group pilot study sponsored by the University of Texas Southwestern Medical Center. It lists 18 participants enrolled and the Serkel 3D CRO device for infants with plagiocephaly, nonsynostotic. The study dates are 2022-05-24 to primary completion on 2024-04-05.
The primary outcome is change in CVA, measured in millimeters, from baseline to approximately 4-6 months. The record defines CVA and describes possible hand or scanner measurement. It lists two outcome measures and zero analyses, but does not report numerical primary outcome results or the analysis population.
The adverse-event entry lists 18 participants at risk, zero affected by serious adverse events, zero affected by other adverse events, and zero deaths. The study has no randomized allocation or control group; its results are not a like-for-like comparison.