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 Collaboration Live (NCT04243369), a na na study. The primary outcome is Rate of Clinically Acceptable Performance of Remote Control Functionality.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04243369 |
| Phase | NA |
| Condition | Pregnancy Related |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Philips Clinical & Medical Affairs Global |
| Results posted | Yes |
2. Clinical Question
Population
Participants with a pregnancy-related condition who provided written consent and underwent scanning. The registry records enrollment of 30 participants. It does not report further eligibility details or the number included in the primary endpoint analysis.
Intervention
Collaboration Live, described as a non-diagnostic software solution, used with a Philips EPIQ 5 or EPIQ 7 Ultrasound System. The study evaluated conferencing, sharing and control capabilities, as well as the utility of remote consultation.
Comparator
There was no separate comparator group. The study is recorded as single-group, with allocation listed as NA and masking as none. It therefore does not provide a like-for-like controlled comparison.
Primary question
What percentage of exams had clinically acceptable performance of the remote-control functionality? Acceptability was defined as the system responding to remote input as intended, without a delay that interfered with the exam, and with no adverse events related to the control feature.
The primary endpoint is framed around performance during an exam, rather than a comparison of clinical outcomes between groups. Its stated timeframe is intra-procedural (1 day). The registry also lists secondary questions concerning technical issues, key-task success, travel reduction, ease of use, user feedback, patient feedback about remote consultation and reimbursement impact. These topics give the study a broader focus on operation and experience, but the registry record does not report results for them.
The question is descriptive: it concerns performance in the enrolled group using the software during the study examinations. Without a comparator group, it does not estimate how performance would differ under another approach. The registry record does not report the primary endpoint value, the number of exams assessed, or its confidence interval. Consequently, the stated question can be described, but its observed answer cannot be read from the registry record.
3. Trial Design
Collaboration Live is recorded as a prospective, single-arm clinical study with a single-group model. Enrollment was 30. Allocation is listed as NA, masking as none, and phase as NA. The status is completed. The recorded study start was 2020-01-09, and primary completion was 2020-02-20. The sponsor is Philips Clinical & Medical Affairs Global.
Participants provided written consent and were scanned using a Philips EPIQ 5 or EPIQ 7 Ultrasound System equipped with Collaboration Live software. The intervention is described in the registry as a non-diagnostic software solution. The study investigator was to evaluate the conferencing, sharing and control capabilities, and the utility of remote consultation. The brief summary also states that adverse events would be reported and assessed for potential relation to the study device or procedure.
The design does not include a separate control arm. The record therefore supports description of experience and performance in this study group, but not a randomized or controlled comparison. The enrollment figure is not necessarily the number of exams or the number of participants contributing to every outcome; those analysis counts are not reported in the registry record.
The brief summary states that no patient follow-up beyond the initial consultation would be conducted with the Collaboration Live software solution. That describes follow-up using the software and should not be expanded into a claim about every form of follow-up. The registry record does not report additional protocol details, such as the sample-size justification, eligibility criteria beyond written consent and the pregnancy-related condition category, or the statistical analysis plan.
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 | Experimental - Collaboration Live Software |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| 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 | Experimental - Collaboration Live Software |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 28.6 (SD 7.0) |
| Sex: Female, Male: Female | Participants | 30 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 18 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 12 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 30 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 30 |
| Gestational age | weeks | 27.8 (SD 6.6) |
| Body Mass Index | kg/m^2 | 34.0 (SD 7.0) |
6. Primary Endpoint
The registry lists the primary outcome as Rate of Clinically Acceptable Performance of Remote Control Functionality, measured over Intra-procedural (1 day).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of total exams |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the rate of clinically acceptable performance of remote-control functionality, expressed as a percentage of total exams. The registry defines acceptable performance as the system responding to remote input as intended, without a delay that interferes with conducting the exam, and with no adverse events related to the control feature. The timeframe is intra-procedural (1 day).
This endpoint focuses on whether remote control operates adequately during the examination itself. It combines a technical criterion—intended response without interfering delay—with a safety-related condition concerning adverse events attributed to the control feature. It is therefore a measure of performance under the study’s stated definition, not a direct measure of comparative clinical benefit.
A percentage of exams is the stated unit, so the relevant denominator is exams rather than necessarily enrolled participants. The registry record does not report the number of exams assessed, the number meeting the acceptability definition, the resulting percentage, or the planned 95% confidence interval. It is therefore not possible to interpret the observed rate or its precision from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the study was completed and enrolled 30 participants, but it does not report the numerical result for the primary endpoint. Although the endpoint specifies a percentage of total exams and a 95% confidence interval, neither the percentage nor its interval is reported in the registry record. The number of exams contributing to the endpoint and the number meeting its definition are also not reported. Completion status alone does not supply an outcome estimate.
The endpoint’s definition is important when interpreting any eventual estimate. It requires an intended remote response, no delay that interferes with the exam, and no adverse events related to the control feature. A reported percentage would describe the proportion of assessed exams meeting that composite operational definition. It would not, by itself, establish comparative performance against another technology or approach, because this was a single-group study without a comparator arm.
A confidence interval would indicate the statistical uncertainty around an estimated rate. In general, a narrower interval indicates greater precision, while a wider interval indicates more uncertainty. The registry record names a 95% confidence interval as the dispersion measure, but does not state the interval’s endpoints or the method used to calculate it. No precision judgment about the observed primary endpoint can therefore be made from this record.
The registry lists 30 participants enrolled, but enrollment should not be treated as the endpoint denominator. The endpoint is defined per exam, and the number of exams may differ from the number of participants. The analyzed population and endpoint-specific denominator are not reported. The registry also does not state whether any exams or participants were excluded from an analysis or how missing endpoint information was handled.
There is one analysis listed in the record, but its details and numerical findings are not reported. The record lists secondary topics including technical issues, key-task success, travel reduction, ease of use, feedback and reimbursement impact. It does not report their results. These outcome labels describe what the study set out to evaluate, not evidence that a particular result was observed.
The serious adverse event figures record zero affected participants among 30 at risk, and the record also reports zero other affected participants and zero deaths. These are descriptive counts for the recorded group. They do not replace the primary performance endpoint, nor do they establish that an event could not occur outside the study observations. The limited follow-up described for use of the software also matters when considering what the event counts cover.
Overall, the registry record gives the study question, design and several outcome definitions, alongside enrollment and safety counts. It does not provide the primary estimate or the secondary outcome results. Interpretation should remain limited to those recorded design features and counts rather than treating the planned evaluations as demonstrated findings.
9. Statistical Methods Explained
The registry describes a single-group study, so its primary endpoint is intended to summarize performance in the enrolled study group rather than estimate a difference between randomized groups. The endpoint is a percentage of total exams meeting a defined criterion. To interpret such a percentage, readers need both the number of qualifying exams and the total number assessed. Neither count is reported in the registry record, and the participant enrollment figure cannot be substituted for the exam denominator without evidence that they are the same.
What does a confidence interval convey?
In general, a confidence interval expresses uncertainty around an estimated quantity. It helps show how precisely the data estimate the underlying rate under the statistical method used. The registry names a 95% confidence interval for the primary endpoint, but does not report its bounds or the calculation method. Without the estimate, denominator and interval, the precision of the primary result cannot be assessed.
A confidence interval is not a guarantee that the true value lies within a particular range, and it does not determine whether a result is clinically important. General interpretation depends on the estimate, the interval, the endpoint definition and the study context. Here, the record contains the endpoint definition but not the estimate or interval, so those interpretations cannot be made.
Why does the study design matter?
General statistical interpretation distinguishes within-group description from comparative inference. This study is listed as single-group, with no allocation to a comparison arm. A measured rate could describe performance in the observed exams, but the design does not provide a direct estimate of a difference versus a control group. Other influences on performance cannot be separated through a randomized between-group comparison in this design.
The record lists no masking. That is a design characteristic, not a finding about whether judgments were biased. The investigator evaluated performance, but the record does not report further procedures for outcome assessment, adjudication or blinding. Those details are not reported in the registry record and should not be assumed.
How should the planning assumptions be read?
The stated sample-size planning illustration is described as computed from the observed effect and not as part of the trial’s own design. Its assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is defined as a stated fraction of the observed effect. These are planning assumptions for an illustration, not evidence that the trial used a two-arm design. The registry identifies the actual study as single-group.
In general, power is a design-stage probability relating to a specified effect and analysis plan. It is not a measure of how likely a completed study’s conclusion is to be correct. Sample-size illustrations are hypothetical planning aids, not observed power. The registry record does not report a trial-specific sample-size justification or the assumptions used to choose enrollment of 30. Because the primary endpoint estimate is not reported in the registry record, the observed effect itself cannot be assessed from this record.
The description of the planning illustration also refers to participants per arm for outcomes other than time-to-event outcomes, and total events for time-to-event outcomes. The primary endpoint is a percentage of exams, and the registry record does not provide an endpoint-specific planning calculation. The stated illustrative two-arm assumptions should not be mistaken for the actual single-group allocation.
What can be inferred from the listed analysis count?
The registry lists one analysis, but does not identify the statistical test, model, estimation procedure, analysis population or treatment of repeated exams. The endpoint is a count-derived rate, but its label alone does not specify the method. General methods for proportions may use different interval calculations or modeling assumptions; the record does not identify which approach was used. No calculation method should be inferred from the endpoint’s unit or confidence-interval label.
Over-dispersion is a general concern when count data vary more than an assumed model allows. It can make uncertainty estimates too narrow if the model does not account for that extra variation. The primary outcome is specified as a percentage of exams, not as an explicitly named count model, and no model assumptions or over-dispersion assessment are reported. This general concept therefore does not establish that over-dispersion was present in this study.
The registry record reports no p-value for the primary endpoint and no inferential comparison. The study’s descriptive aim, as written, centers on performance characteristics and participant and user feedback. Any stronger conclusion would require the actual endpoint results and methods, which are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures and one analysis. The primary outcome concerns clinically acceptable remote-control performance. Listed secondary outcomes address technical issues, key-task success, travel reduction, ease of use, user feedback about streaming, image quality and overall experience, patient feedback about remote consultation, and the impact of remote consultation on reimbursement.
Multiplicity is a general issue when several outcomes are examined: the more statistical questions considered, the greater the chance that some findings may appear notable by chance if no adjustment or prespecified hierarchy is used. The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or which outcomes were considered confirmatory. It also does not report results for the listed secondary outcomes. Their inclusion in the record should not be read as evidence that each was analyzed or achieved a particular result.
The record does not report how missing data were handled, whether all enrolled participants contributed to each outcome, or the analysis population used for the primary endpoint. The number of participants enrolled is stated, but the number of exams assessed and the endpoint-specific denominator are not. No exclusions, imputation method, or sensitivity analysis are reported in the registry record.
These omissions limit assessment of how complete the analyzed data were and whether the analysis matched the intended population. They do not establish that data were missing or that any particular analysis choice was made. The relevant analysis and missing-data procedures are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Experimental - Collaboration Live Software | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Experimental - Collaboration Live Software | 0 of 30 |
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 |
|---|---|
| Experimental - Collaboration Live Software | 0 of 30 |
The registry records 30 participants at risk in the experimental group. It reports zero participants with serious adverse events, zero participants with other adverse events, and zero deaths. No serious adverse event terms are listed. These figures are the safety counts recorded for the group, not a comparison with another group.
A count of zero means that no affected participants are recorded for that category in the registry entry. It does not show that the risk is absent, and it does not establish what might occur in a larger group or under different observation conditions. The record does not report additional detail about event definitions, the method for attributing events, or the duration of safety observation beyond the brief summary’s description of no follow-up beyond the initial consultation using the Collaboration Live software solution.
The brief summary states that adverse events would be reported and that the investigator would assess potential relationships to the study device or procedure. The registry’s zero counts should be read alongside that stated process, while recognizing that the registry record does not provide event narratives or further assessment details. They do not indicate the primary endpoint result, which is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record describes an evaluation of Collaboration Live software used with Philips ultrasound systems, with a primary focus on the proportion of exams meeting the study’s definition of clinically acceptable remote-control performance. The definition includes intended system response, no interfering delay and no adverse events related to the control feature. It also lists secondary evaluations concerning technical performance, remote consultation and user or patient feedback.
The record does not report the observed primary endpoint percentage or its stated 95% confidence interval. It also does not report results for the secondary outcomes. Thus, the outcome definitions establish what the study intended to assess, but they do not reveal the observed performance or feedback. The recorded completion status and enrollment do not fill that gap.
Because the study is single-group and has no comparator, any reported performance rate would describe the examined study experience rather than a controlled estimate of how one approach compares with another. The enrollment figure is 30 participants, but the primary outcome is expressed per exam, and the number of exams assessed is not reported. The analysis denominator and population are also not reported.
The safety entry records zero serious adverse events, zero other adverse events and zero deaths among 30 at risk. These are the recorded counts, not proof that an event is impossible or that every potential safety concern has been resolved. The stated lack of follow-up beyond the initial consultation using the software further limits what can be inferred about observations outside that period.
In general, a study’s result must be interpreted with its design, endpoint definition, denominator, uncertainty and follow-up in view. Here, the registry record supports a description of the intended evaluation and the recorded safety counts, but does not contain the primary or secondary outcome estimates needed to characterize observed performance.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary question is framed as a performance rate within a single group rather than as a treatment contrast. That distinction determines what the design can describe. A percentage of exams meeting a specific operational definition can summarize observed performance, but a single-group study does not provide a randomized comparison against another approach.
The endpoint also illustrates why the unit of analysis matters. Enrollment is stated as 30 participants, while the primary endpoint is defined as a percentage of total exams. Those quantities are not interchangeable unless the relationship between participants and exams is known. The registry record does not report the exam denominator, the qualifying count or the endpoint estimate.
The endpoint combines technical and safety-related criteria. Clear definitions matter because a reported rate would depend on how the intended response, interfering delay and relationship of adverse events to the control feature were assessed. The registry supplies the definition, but does not report assessment procedures or the result. That gap prevents evaluation of both the rate and its statistical precision.
The study also lists several secondary questions spanning technical issues, task success, travel, usability, feedback and reimbursement. Such breadth can be informative, while making clear reporting of outcome-specific results and analysis procedures important. The registry record lists eight outcomes and one analysis but does not report the results or a multiplicity approach.
Finally, the record distinguishes enrollment and safety counts from outcome evidence. The zero recorded adverse-event counts are relevant descriptions, but they do not provide the missing performance estimate. Keeping those different statistical quantities separate is essential to a careful reading of this completed 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 main limitation for interpreting the registry record is that it does not report the primary endpoint result. Although it defines the endpoint as a percentage of total exams and names a 95% confidence interval, neither the estimate nor the interval is recorded. The number of exams and number meeting the acceptability definition are also absent, so the rate and its precision cannot be evaluated.
The study is single-group, with allocation listed as NA and masking as none. There is no separate comparator group for a like-for-like comparison. The registry record does not report the primary analysis method, analysis population, handling of missing data, outcome assessment procedures or a sample-size justification. It lists secondary outcome topics but does not report their results.
Enrollment of 30 participants does not establish that 30 participants contributed to the primary endpoint, and it does not establish the number of exams assessed. The primary outcome’s exam-based denominator is not reported. The registry describes no follow-up beyond the initial consultation using the Collaboration Live software solution, limiting interpretation of observations made outside that stated period.
The record’s completed status does not resolve these reporting gaps. Nor do the recorded zero adverse-event counts supply the missing endpoint estimate or establish the absence of risk beyond the recorded observations. These limitations are specific to the information recorded for this study and restrict interpretation of its observed performance.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Collaboration Live — NCT04243369.
- Registry record last updated 2020-12-04; status last verified 2020-11.
- Results first posted 2020-12-04.
- 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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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 identifies Collaboration Live as a prospective, single-arm study of a non-diagnostic software solution used with a Philips EPIQ 5 or EPIQ 7 Ultrasound System. It records enrollment of 30 participants, a pregnancy-related condition category, no masking, and completed status. The recorded study start was 2020-01-09 and primary completion was 2020-02-20.
The primary outcome is the percentage of exams with clinically acceptable remote-control performance during the intra-procedural timeframe (1 day), with a stated 95% confidence interval. The registry record does not report the endpoint result or its confidence interval. It lists seven secondary outcome topics and one analysis but does not report their results or analysis details.
The safety entry records zero serious adverse events, zero other adverse events and zero deaths among 30 at risk. The record does not report further details about the analysis population, exam denominator, missing data or sample-size justification.