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 SmartHMD for Improved Mobility (NCT03781583), a non-randomized na study. The primary outcome is Time-to-Complete.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03781583 |
| Phase | NA |
| Condition | Low Vision, Orientation, Mobility Limitation |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 21 |
| Arms in the primary outcome | n/a |
| Lead sponsor | James Weiland |
| Results posted | Yes |
2. Clinical Question
Population
People with low vision or visual impairment undertaking orientation and mobility tasks. The registry describes tasks involving indoor navigation and crossing an outdoor crosswalk; it does not give further eligibility details in the record.
Intervention
SmartHMD, a head-mounted display system developed in successive versions. Device configurations used smart glasses, custom software, audio equipment, and, in later versions, a Jetson mobile computer.
Comparator
No randomized or like-for-like control group is described. The study is registered as non-randomized and single-group, with participants using different SmartHMD versions and undertaking different tasks.
Primary question
How long did participants take to complete their assigned mobility task while using the relevant SmartHMD configuration? The primary endpoint is time-to-complete, measured in seconds.
The practical focus is mobility in settings where navigation can be challenging for people with low vision. The registry describes a signaled-crosswalk task as a specific problem of interest, alongside indoor tasks such as locating a door and navigating an indoor course. Its stated central hypothesis is that an electronic navigation system incorporating computer vision could enhance orientation and mobility.
The primary outcome addresses task duration, not whether participants navigated safely, independently, or with greater confidence. The registry also lists secondary outcomes concerning preferred walking speed, unintended contacts with obstacles and walls, incorrect turns, and interventions. Those measures concern aspects of task performance distinct from completion time, but numerical findings for them are not reported in the registry record.
Because the study is single-group and non-randomized, its record does not establish a comparative treatment effect against an untreated group or another navigation aid. The clinical question is therefore best read as an evaluation of task performance while using the studied device configurations, rather than a controlled test of whether SmartHMD improves mobility relative to an alternative.
3. Trial Design
The registry identifies SmartHMD for Improved Mobility as a completed study with non-randomized allocation, no masking, and a single-group model. Enrollment is listed as 21. The study is described as having four device configurations, associated with outdoor-crosswalk and indoor-course tasks. This structure reflects successive SmartHMD versions and settings, not a randomized comparison between equivalent groups.
The first configuration used commercially available ODG R7 smart glasses, custom software, and accompanying earbuds for an outdoor crosswalk task. The second used RGB-D smart glasses, a laptop running custom software, and bone-conducting earphones to locate a door within an indoor course. Another configuration paired RGB-D smart glasses and bone-conducting earphones with a Jetson mobile computer for an indoor course. The final listed configuration used RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and a specific custom-software version for an outdoor crosswalk task.
The primary endpoint was time-to-complete, measured in seconds, with a stated timeframe of 2 hours. The record describes it as the duration from the start of a trial until the subject completed the assigned task. The population description excludes data for participants who did not show up, experienced equipment malfunctions, or could not complete the task. The record does not explain how many observations were excluded for each reason.
Non-random allocation and the lack of masking limit interpretation of differences across configurations. The device versions were paired with different tasks or settings, and the record does not describe a common control condition. Differences between cohorts could therefore reflect the device, the task, the setting, participant characteristics, or other factors. The registry record does not report a protocol-level statistical plan or the details of any comparisons across configurations.
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: Of 21 people consented, 2 individuals failed post start-up screening, and 1 never came in for any assignment. That brings the 21 consented to 18. Participants could consent and enroll in multiple cohorts, reconsenting for each cohort in which they participated. The numbers shown in each arm represent each individual who initially enrolled in that cohort. Some continued on to participate in further tests, but no participant appears in more than one arm in Participant Flow.
Overall Study
| Stage | Cohort A: Outdoor and ODG | Cohort B: Indoor and Laptop | Cohort C: RGBD & Jetson - Indoor Course | Cohort D: RGBD & Jetson - Outdoor Crosswalk |
|---|---|---|---|---|
| STARTED | 4 | 5 | 8 | 1 |
| Participated and Completed Indoor Doorfinding Test | 1 | 3 | 0 | 0 |
| RGBD & Jetson Test | 0 | 2 | 8 | 0 |
| RGBD Outdoor Crosswalk Test | 0 | 1 | 1 | 1 |
| COMPLETED | 2 | 3 | 8 | 1 |
| NOT COMPLETED | 2 | 2 | 0 | 0 |
Reasons for not completing this period:
| Reason | Cohort A: Outdoor and ODG | Cohort B: Indoor and Laptop | Cohort C: RGBD & Jetson - Indoor Course | Cohort D: RGBD & Jetson - Outdoor Crosswalk |
|---|---|---|---|---|
| Technical issue prevents the device from starting properly | 1 | 0 | 0 | 0 |
| Technology did not work for that person in that environment | 1 | 0 | 0 | 0 |
| Participant was not sufficiently visually impaired | 0 | 1 | 0 | 0 |
| Pilot test of course took place in different location, data not comparable to other participant data | 0 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Data are not included for those participants who did not show up, equipment malfunctions or persons unable to complete the task.
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: The numbers shown in each arm below represent one person beginning in that cohort.
| Characteristic | Unit | Cohort A: Outdoor and ODG | Cohort B: Indoor and Laptop | Cohort C: RBDG & Jetson -Indoor | Cohort D: RGBD & Jetson - Outdoor Crosswalk | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 4 | 5 | 8 | 1 | 18 | |
| Age, Customized: Age | Participants | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 0 | 5 | 4 | 1 | 10 |
| Sex: Female, Male: Male | Participants | 4 | 0 | 4 | 0 | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 4 | 5 | 8 | 1 | 18 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 | 5 | 8 | 1 | 18 |
| Region of Enrollment: United States | Participants | 4 | 5 | 8 | 1 | 18 |
| Preferred Walking Speed: Preferred walking speed of those testing the indoor course (Test C) | meters/second | — | .622 (.427 to .817) | .968 (.76 to 1.156) | — | .899 (.427 to 1.156) |
| Preferred Walking Speed: Preferred walking speed of those testing the outdoor course (Test D) | meters/second | — | .817 (.817 to .817) | 0.76 (.76 to 0.76) | 1.15 (1.15 to 1.15) | .909 (.76 to 1.15) |
6. Primary Endpoint
The registry lists the primary outcome as Time-to-Complete, measured over 2 hours.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | Seconds |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint, time-to-complete, measures the elapsed time from the start of a trial until a participant finishes the assigned task. It is expressed in seconds, and the registry gives a timeframe of 2 hours. In this study, the assigned task could involve navigation through an indoor course or across an outdoor crosswalk, depending on the device configuration and cohort.
Completion time is a direct, observable measure of task duration. It can help describe how quickly a task was completed, but it does not by itself capture all dimensions of mobility performance. A shorter duration, considered alone, would not establish that a task was completed safely, accurately, or with less assistance. The registry lists secondary measures related to walking speed, unintended contacts, incorrect turns, and interventions, which address other facets of performance. Their numerical results are not reported in the registry record.
The planned summary is a mean with full-range dispersion. In general, a mean describes the arithmetic average of observed values, while the full range gives the lowest and highest values. A range can indicate how widely completion times varied, but it can also be strongly affected by extreme observations. The record does not provide the primary endpoint mean or range, or the number of endpoint observations contributing to those summaries.
The endpoint population excludes people who did not attend, encountered equipment malfunctions, or were unable to complete the task. This makes the measure specifically about recorded completion times among eligible completed trials, rather than a summary that necessarily includes everyone enrolled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the study design and the intended mobility tasks, but it does not report numerical results for time-to-complete. It gives no primary endpoint mean, full range, or outcome analysis. Consequently, the record does not support a quantitative statement about how long participants took, how variable completion times were, or how performance differed across SmartHMD configurations.
The record lists secondary outcomes, but it does not report numerical results for preferred walking speed, unintended contacts with obstacles and walls, incorrect turns, or interventions. Those outcomes cannot be used to fill in the absent primary result, and their absence means that performance cannot be characterized across these other dimensions from the registry record.
The study is identified as non-randomized and single-group, with no masking. The configurations also differ in equipment and assigned task or setting. Any descriptive differences between cohorts, if reported elsewhere, would not automatically isolate an effect of a device version. The registry record does not describe a randomized allocation process, a like-for-like control group, or an analysis that adjusts for differences between cohorts. In general, when treatment and task conditions are not assigned in a way that balances relevant factors, observed differences can have several explanations.
Enrollment is listed as 21, but the record does not provide the number of participants contributing to each primary endpoint summary. It specifically states that data are not included for people who did not show up, had equipment malfunctions, or could not complete the task. The number excluded for each reason and the number with an observed completion time are not reported in the registry record. As a result, the relation between enrollment and the endpoint analysis population cannot be assessed from this record.
The registry lists zero serious adverse events, zero other adverse events, and zero deaths for each of the four named groups. These are event counts as recorded for those groups; they do not substitute for mobility-performance results. The record does not give further detail about adverse-event collection or specify how the safety observation period relates to each task.
In general, a numerical outcome estimate is most informative when read alongside its uncertainty and the number of observations behind it. Neither an endpoint estimate nor an uncertainty interval is reported. The appropriate conclusion is therefore limited: the registry documents a completed, early-stage device study with several configurations and task settings, but the posted record does not provide the results needed to quantify task performance or its precision.
9. Statistical Methods Explained
The registry classifies the allocation as non-randomized and the model as single-group. These labels matter because they describe what kinds of statistical comparisons the design can support. Random assignment is one way to make groups comparable with respect to both measured and unmeasured characteristics, on average. This study does not report random assignment, and it does not describe a separate control group. In general, results from such a design can describe observed task performance, but they do not by themselves establish that the device caused a difference relative to another approach.
The study includes multiple SmartHMD versions and task settings. The listed configurations range from ODG R7 smart glasses and earbuds for an outdoor-crosswalk task to RGB-D glasses paired with a laptop or Jetson mobile computer for indoor or outdoor navigation. This is not simply a comparison of versions under one shared task: the task and setting vary as well. In general, when groups differ in more than the device configuration, a contrast between their outcomes can combine effects of the device with effects of the task, setting, participant mix, or other differences. The registry record does not report a statistical strategy for separating those influences.
The primary endpoint is a continuous measure: elapsed time in seconds. The planned descriptive statistic is the mean, accompanied by the full range. A mean uses every recorded value and provides a measure of average completion time. The range describes the endpoints of the observed values, rather than the uncertainty of the mean. In general, the range can be sensitive to an unusually small or large observation, and it tends to widen as more observations are included. A confidence interval, by contrast, is a measure of uncertainty around an estimated quantity under a statistical model. No confidence interval for the primary endpoint is reported in the registry record.
The endpoint population excludes people who did not show up, experienced equipment malfunctions, or could not complete the task. This definition has a statistical consequence: the endpoint summary describes the subset with an eligible recorded completion time, not necessarily every enrolled participant. In general, excluding observations can lead to a biased summary if the probability of exclusion is related to task performance. For example, people unable to complete a task do not have a completion time of the same kind as those who finish, so excluding them changes the question being answered. The registry record does not report the number excluded, reasons by participant, or a sensitivity analysis addressing these exclusions.
The registry lists four secondary outcomes: percentage of preferred walking speed, number of unintended contacts with obstacles and walls, number of incorrect turns, and number of interventions. These outcomes have different statistical properties. Walking-speed measures are quantitative, whereas counts of contacts, turns, and interventions are count outcomes. In general, count data can be skewed, include many zeros, or show greater variability than a simple model assumes. Over-dispersion means the observed variation is greater than the model's expected variation; accounting for it can affect standard errors and confidence intervals. The registry record does not report a model for these outcomes or provide numerical analyses.
The record lists no analyses. It does not report a hypothesis test, adjusted or unadjusted estimates, confidence intervals, or an approach to comparing the versions. A p-value, when reported, summarizes how compatible observed data are with a specified null model; it is not a measure of effect size or the probability that a hypothesis is true. No p-value is reported for the primary endpoint in this record, so statistical significance cannot be assessed. More importantly, without an effect estimate and its precision, the magnitude of any observed task-performance pattern cannot be evaluated.
The sample-size assumptions described in the record refer to a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such assumptions are not a description of the actual study design: the registered study is non-randomized and single-group. In general, sample-size calculations are planning tools that indicate the amount of information a hypothetical design might require under specified assumptions. They do not demonstrate that a study had a particular probability of detecting an effect, and they do not replace a reported analysis. The registry record does not report a protocol-based sample-size justification or any outcome-specific planning details beyond that illustration.
The central statistical limitation is therefore not a particular model choice but the lack of posted outcome analyses. Without estimates, observation counts, and uncertainty measures, readers cannot assess the size or precision of task completion times or the secondary outcomes. The design also limits causal interpretation even if descriptive differences were available. Further statistical detail, including any methods used outside the registry, is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists one primary outcome and four secondary outcomes. It does not describe how the primary endpoint was to be analyzed, whether secondary outcomes were considered confirmatory or exploratory, or whether any adjustment for multiple testing was planned. The multiplicity strategy is not reported in the registry record.
In general, testing multiple outcomes or making repeated comparisons increases the chance of finding an apparently unusual result by chance if each test is interpreted separately. Statistical plans may address this through prespecified outcome hierarchies, adjustments to significance thresholds, or by describing secondary analyses as exploratory. The registry record does not say whether any such approach was used. Since no outcome analyses or p-values are reported, there is no posted set of tests from which to judge how multiplicity was handled.
Missing endpoint data are relevant because the primary outcome excludes people who did not attend, experienced equipment malfunctions, or were unable to complete the task. The number of participants omitted for each reason, the amount of missing data by configuration, and any imputation or sensitivity analysis are not reported in the registry record. In general, an analysis of completers can describe those with observed completion times, but may not represent everyone enrolled if exclusions are related to performance.
The record also does not report a detailed analysis population definition beyond the stated exclusions, or provide the number of participants included in each endpoint summary. Enrollment is listed as 21, but the endpoint denominator cannot be determined from the record. No information is reported about protocol deviations or how they were handled in the analysis.
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 |
|---|---|---|---|
| Outdoor and ODG Test Participants | 0 | 4 | 0.0% |
| Cohort B: Indoor and Laptop Test Participants | 0 | 6 | 0.0% |
| Cohort C: RGBD & Jetson - Indoor Test Participants | 0 | 10 | 0.0% |
| Cohort D: RGBD & Jetson - Outdoor Crosswalk Test Participants | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Outdoor and ODG Test Participants | 0 of 4 |
| Cohort B: Indoor and Laptop Test Participants | 0 of 6 |
| Cohort C: RGBD & Jetson - Indoor Test Participants | 0 of 10 |
| Cohort D: RGBD & Jetson - Outdoor Crosswalk Test Participants | 0 of 3 |
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 |
|---|---|
| Outdoor and ODG Test Participants | 0 of 4 |
| Cohort B: Indoor and Laptop Test Participants | 0 of 6 |
| Cohort C: RGBD & Jetson - Indoor Test Participants | 0 of 10 |
| Cohort D: RGBD & Jetson - Outdoor Crosswalk Test Participants | 0 of 3 |
The registry lists serious adverse events, other adverse events, and deaths separately for each named cohort. For Outdoor and ODG Test Participants, 0 serious events and 0 other events are reported among 4 participants at risk, with 0 deaths. For Cohort B: Indoor and Laptop Test Participants, 0 serious events and 0 other events are reported among 6 participants at risk, with 0 deaths. For Cohort C: RGBD & Jetson - Indoor Test Participants, the posted figures are 0 serious events and 0 other events among 10 participants at risk, with 0 deaths. For Cohort D: RGBD & Jetson - Outdoor Crosswalk Test Participants, the figures are 0 serious events and 0 other events among 3 participants at risk, with 0 deaths.
These entries describe what was recorded in the registry for the listed groups. They do not establish that an event was impossible or that the device has no risks. In general, zero observed events in a limited group do not rule out events that were not observed, and interpretation depends on how events were defined, collected, and monitored. Further details about safety monitoring and the observation period are not reported in the registry record.
The registry lists no serious adverse-event terms. The safety entries should be read separately from the mobility outcomes: they do not report completion times, navigation accuracy, or the frequency of contacts or interventions.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed study evaluated successive SmartHMD configurations in mobility tasks involving indoor navigation and outdoor crosswalks. It specifies a primary measure of task duration, along with secondary measures concerning walking speed, contacts, incorrect turns, and interventions. It also lists adverse-event counts for each cohort.
What the record does not establish is the observed performance on these measures. Numerical primary and secondary outcome results are not reported in the registry record. There is no reported mean or full range for completion time, no endpoint observation count, and no uncertainty estimate. The registry record therefore does not show how long tasks took or how much performance varied.
The study design also constrains what can be concluded. It is registered as non-randomized, single-group, and unmasked, with different configurations tied to different tasks or settings. This does not provide a like-for-like control comparison. Even if results were available, observed contrasts among the configurations would not necessarily isolate the effect of the device version from differences in task, setting, or participant characteristics.
In general, task duration is only one dimension of mobility. A time measure alone does not determine whether navigation was accurate, safe, or independent. The secondary outcomes could provide complementary information, but their numerical findings are not reported. Similarly, the zero adverse-event counts in the registry are descriptive entries for the listed cohorts; they do not provide a comprehensive estimate of risk beyond the recorded observation.
The registry record supports a description of the study's aims, design, endpoint definitions, and posted safety counts. It does not support a quantitative claim about the size, direction, or precision of any mobility-performance result, nor a causal claim that SmartHMD changed performance relative to another approach. Those conclusions would require outcome data and appropriate context that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable because its practical objective is broader than a single endpoint. The registry frames SmartHMD as a system intended for orientation and mobility, while the primary measure captures only elapsed task time. Secondary outcomes concerning walking speed, obstacles, turns, and interventions point to distinct components of performance. Considering more than one dimension is important when a task involves both navigation and completion.
The design also illustrates why the structure of a device study matters for interpretation. SmartHMD versions were used in different settings and tasks, and the registry identifies the study as non-randomized and single-group. Such work can describe feasibility and performance in the tested circumstances, but a comparison across versions would be difficult to interpret if the setting and task also change. Clear reporting of group-specific outcomes, denominators, and uncertainty would help readers distinguish observed patterns from explanations about why those patterns occurred.
Missing outcome reporting has a direct statistical consequence: readers cannot assess either the magnitude or precision of task performance. A stated endpoint and a completed study do not, on their own, provide evidence about the distribution of observed outcomes. Publishing outcome summaries and the number of observations behind them would allow assessment of variability and the extent to which exclusions affected interpretation.
The record also highlights the importance of defining the analysis population. Participants who did not attend, had equipment malfunctions, or could not complete the task are excluded from the primary endpoint description. Reporting how often these circumstances occurred and how they were handled would clarify whether completion-time summaries represent the intended study population or only those with successful, measurable trials.
For clinical researchers, this example emphasizes the need to align a design, endpoint, and analysis with the claim of interest. A single-group evaluation can describe what happened during assigned tasks; a comparative causal question requires a design and analysis that support that comparison. Outcome transparency is necessary in either case.
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 trial-specific limitation in the registry record is the absence of numerical outcome findings. The record defines time-to-complete and names secondary outcomes but does not report their estimates, distributions, or uncertainty. This prevents readers from evaluating task performance, variation across observations, or patterns across device configurations.
The study is non-randomized and single-group, with no masking. The four configurations are associated with differing equipment and tasks, including indoor-course and outdoor-crosswalk activities. Because device, setting, and task are not held constant across all listed groups, comparisons between them would be difficult to attribute to a device change alone. The registry record does not describe a control condition or an adjustment strategy that could address such differences.
The primary endpoint excludes people who did not show up, experienced equipment malfunctions, or could not complete the assigned task. The number excluded for each reason and the number contributing to the reported endpoint are not reported in the registry record. Those omissions matter because completion-time results among task completers may not describe the experience of all enrolled participants.
The record does not provide detailed eligibility criteria, baseline participant characteristics, a statistical analysis plan, or an explanation of how the secondary outcomes were analyzed. The multiplicity approach and missing-data methods are not reported in the registry record. Without these details, it is not possible to assess the planned inferential framework or the potential impact of data exclusions.
Finally, the registry's safety entries are limited to event counts for the listed cohorts. Further information about event definitions, monitoring, and observation duration is not reported in the registry record. These limitations concern what can be concluded from the registry record; they do not establish that additional information was not collected elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: SmartHMD for Improved Mobility — NCT03781583.
- Registry record last updated 2024-12-12; status last verified 2024-12.
- Results first posted 2024-12-12.
- 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
SmartHMD for Improved Mobility is registered as a completed, non-randomized, unmasked, single-group study with enrollment listed as 21. It evaluates four head-mounted display configurations used for indoor navigation or outdoor-crosswalk tasks. The primary endpoint is time-to-complete in seconds, summarized as a mean with full range. Its endpoint population excludes people who did not show up, experienced equipment malfunctions, or could not complete the task.
The registry lists four secondary outcomes: percentage of preferred walking speed, unintended contacts with obstacles and walls, incorrect turns, and interventions. It reports zero serious adverse events, zero other adverse events, and zero deaths for each listed cohort. Numerical results for the primary and secondary outcomes, endpoint denominators, and statistical analyses are not reported in the registry record. The non-randomized, single-group design does not provide a like-for-like control comparison, and differences across configurations would need to be interpreted in light of their different tasks and settings.