Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP (NCT06119568), a na na study. The primary outcome is Lack of Occurrence of a SAE Related to the Use of the Medical Devices Under Investigation During the Intervention.

2. Clinical Question

The investigation asked whether the Bitrack System, together with its compatible ElectroSurgical Endoscopic and Non-ElectroSurgical Endoscopic instruments and accessories, could assist surgeons during robot-assisted laparoscopic radical nephrectomy, partial nephrectomy, or radical prostatectomy without a serious adverse event related to use of the devices during the intervention.

This is a device-safety and performance question, rather than a comparison of surgical approaches. The registry summary describes the study as a confirmatory investigation of whether the devices performed as intended by the surgeon. Its primary endpoint is specifically framed around the absence of a device-related serious adverse event during the intervention. The record also says that study data were collected up to 30 days after surgery, while the primary endpoint’s stated timeframe is during the procedure. The registry does not report a control group or a comparative treatment-effect question.

3. Trial Design

HYROS-PRnP (NCT06119568) is a completed, single-group clinical investigation of the Bitrack System and compatible instruments and accessories. The registry lists 15 participants as enrolled. The intervention was robot-assisted laparoscopic radical or simple nephrectomy, partial nephrectomy, or radical prostatectomy, as applicable. Participants were surgically treated with the Bitrack System and ESE/NESE instruments and accessories.

The registry records allocation as NA and masking as none. It therefore does not describe random assignment or blinded assessment. There is no separate comparator arm in the record, so the study is not a like-for-like comparison of the device with another system or with surgery performed without it. Its results are descriptive for the treated group and do not, by themselves, estimate a comparative effect.

The study began on 2023-11-01, reached primary completion on 2024-04-01, and is listed as completed. The phase is recorded as NA. The registry summary says the investigation collected data up to 30 days post-surgery and was intended to provide evidence that the tested devices fulfilled the GSPR. That summary does not specify how each outcome was assessed across that period.

The primary outcome is a count of serious adverse events related to use of the devices during the procedure. The registry lists two outcome measures and one analysis, but the other outcome’s details and the analysis methods are not reported in the registry record. The protocol’s sample-size justification, any interim analyses, and the full statistical analysis plan are also not reported in the registry record. The enrollment figure describes the study group; it does not establish how many participants contributed data to each outcome.

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

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: Adult subjects between 18 and 90 years old who have provided written informed consent prior to be treated with a robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP). During each of these procedures removal of regional lymph nodes (lymphadenectomy) and/or lysis of abdominal lesions could be performed according to patient medical condition and/or surgeon criteria.

6. Primary Endpoint

The registry lists the primary outcome as Lack of Occurrence of a SAE Related to the Use of the Medical Devices Under Investigation During the Intervention, measured over During the procedure.

The primary endpoint is the number of serious adverse events related to use of the medical devices under investigation during the procedure. Its description frames the intended assessment as whether the Bitrack System could assist with accurate control of its compatible ESE/NESE instruments without causing a particular device-related serious adverse event. The specified timeframe is during the procedure.

This endpoint is used to assess a safety concern tied to the devices and their use in surgery. A serious adverse event is a clinically important safety outcome, while the attribution requirement narrows the endpoint to events considered related to the devices. The endpoint therefore does not capture every possible surgical complication, nor does it measure comparative performance against another system. The registry does not report how relatedness or seriousness was determined, who made those judgments, or whether an independent review was used.

The measure is recorded as a number of serious adverse events, but the registry’s safety figures separately report the number affected. Those figures list 0 participants affected by serious adverse events in the treated group. They do not, on their own, document the event-attribution process for the primary endpoint. The primary endpoint’s event count and its complete analysis details are not reported in the registry record. The study summary notes data collection through 30 days after surgery, but this is distinct from the primary endpoint’s procedure-only timeframe.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical interpretation depends first on the structure of the study. The registry describes a single group, with allocation recorded as NA and masking recorded as none. In general, a single-group study can describe what happened among participants who received the intervention, but it does not directly estimate how outcomes would differ under a comparator. Without a control group, observed events cannot be attributed to the device by comparison alone.

What does a count endpoint represent?

The primary endpoint is recorded as a number of serious adverse events related to use of the devices during the procedure. A count endpoint concerns the number of events, which is not necessarily the same as the number of participants who experience at least one event: a participant could, in principle, experience more than one event. The registry safety figures also include an affected-participant count, listing 0 participants affected by serious adverse events. The endpoint’s full numerical result and the relationship between the endpoint count and the affected-participant figure are not reported in the registry record.

In general, a count can be interpreted in relation to the observation period and the population at risk. A rate would additionally require a clearly specified exposure denominator, such as time at risk, and an analysis method appropriate to that denominator. The registry record does not report such a rate for the primary outcome. It describes the endpoint as a number and gives the timeframe as during the procedure.

Why does event rarity matter?

In general, uncommon adverse events are difficult to characterize precisely in a small study. When no events are observed, that result is compatible with a low underlying risk, but it does not prove the risk is absent. A confidence interval expresses the range of values compatible with the observed data under a statistical model; it helps communicate uncertainty rather than just the observed count. No confidence interval for the primary endpoint is reported in the registry record.

Counts can also vary more than a simple model assumes, a property often called over-dispersion. In general, over-dispersion matters because an analysis that assumes less variability than the data have can produce confidence intervals that are too narrow and tests that appear more conclusive than warranted. Whether over-dispersion was assessed, and what model was used for the primary endpoint, are not reported in the registry record. Since the posted serious-event figure is zero, the record does not provide event variation from which to evaluate a count model’s fit.

What can the study design support?

For a single group, the direct statistical description is the observed safety experience in that group. In general, a comparative estimate requires outcomes in a comparator group and a defined contrast between groups. The registry lists no comparator arm, so a relative risk, risk difference, or other treatment contrast is not reported. No adjusted analysis, stratification, or covariate model is described in the registry record.

The registry records one analysis and two outcome measures, but the analysis method, outcome hierarchy, and detailed specifications for the other outcome are not reported in the registry record. It is not possible to determine from the record whether the analysis was prespecified, how any deviations were handled, or whether additional analyses were conducted outside the registry entry. A p-value is also not reported. In general, a p-value does not measure clinical importance or prove that an effect is real; it quantifies compatibility with a specified null model under stated assumptions. Without the model and analysis details, it would be inappropriate to infer one.

How should planning illustrations be read?

The sample-size planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are described as planning illustrations based on a fraction of an observed effect, not as the original design calculation. For time-to-event outcomes, the stated convention is a total number of events; for other outcomes, the convention is participants per arm. These planning assumptions do not describe this study’s single-group design, and the illustrations are not observed power. The protocol’s own sample-size justification is not reported in the registry record.

In general, a planning calculation asks what sample size might be needed to detect a specified effect under specified assumptions. It does not show the probability that a completed study detected an effect, and it cannot turn a single-group result into a comparative finding. Here, no observed effect estimate for a two-arm contrast is reported in the registry record. The illustrations therefore should not be read as evidence about the study’s success or the precision of its safety result.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and one analysis. It does not report the details of the other outcome measure, how outcomes were prioritized beyond identifying a primary endpoint, or whether any multiplicity adjustment was planned or applied. When several outcomes or statistical tests are considered, the chance of obtaining at least one apparently notable result can increase. In general, multiplicity procedures can address that issue, but their relevance depends on the analysis plan and the claims being made. The record does not provide enough detail to determine how multiplicity was handled.

Missing-data methods and analysis populations are not reported in the registry record. The enrollment figure is 15, but the record does not state whether all enrolled participants were included in each outcome analysis, whether any participants were excluded, or whether outcome data were incomplete. It also does not describe how missing observations, withdrawals, or protocol deviations were handled.

The registry summary says data were collected up to 30 days post-surgery, while the primary endpoint timeframe is during the procedure. It does not explain the follow-up schedule for other outcomes or whether the safety figures refer to the full stated collection period. The protocol’s interim-analysis plan, if any, is not reported in the registry record. These omissions limit assessment of analysis completeness, outcome ascertainment, and the risk that selective reporting affected the posted results.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The safety figures list 15 participants at risk for serious adverse events and 0 affected. They also list 15 at risk for other adverse events and 11 affected, with 0 deaths. These figures describe the treated group; they do not provide a comparator-based estimate.

The primary endpoint concerns serious adverse events related to device use during the procedure. The adverse-event summary does not state how relatedness was assessed or whether its serious-event figure is restricted to events meeting that primary endpoint definition. The summary’s timeframe is not specified for all safety figures. Accordingly, the posted count of 0 affected should be read as a descriptive registry result, not as proof that serious device-related events are impossible.

The record does not report the types or clinical details of the 11 other adverse events, their timing, severity, or relationship to the devices. It also does not give a confidence interval for the serious adverse event result. In general, a zero observed count can still be statistically uncertain, especially when the study group is limited and rare events are of interest. The safety figures do not establish how outcomes would compare with another system or surgical approach.

12. What the Result Does, and Does Not, Mean

The registry describes a completed investigation of the Bitrack System and compatible ESE/NESE instruments and accessories in robot-assisted nephrectomy and prostatectomy procedures. The group included 15 enrolled participants. The posted safety figures list 0 participants affected by serious adverse events and 11 affected by other adverse events; the record also lists 0 deaths. These are observations from the treated group.

The primary question concerns serious adverse events related to device use during the procedure. The registry does not provide the full endpoint analysis, including an estimate of uncertainty or the method used to establish device relatedness. The summary says data were collected up to 30 days post-surgery, but the primary endpoint timeframe is during the procedure. The record does not give enough detail to reconcile those timeframes for the broader safety figures.

The findings do not establish that the device is free of risk. A lack of observed serious events in a study group does not show that the underlying event probability is zero. The registry also has no comparator arm, so it cannot show whether safety or performance differs from another device, surgical technique, or standard of care. No comparative effect estimate is reported.

The investigation’s stated purpose included evaluating device performance as intended by the surgeon and providing evidence that the devices fulfilled the GSPR. The registry summary characterizes the study as confirmatory, but the detailed performance outcomes and analysis methods are not reported in the registry record. The posted information therefore supports a limited descriptive reading of the recorded safety counts, not a broad conclusion about comparative effectiveness, generalizability, or the absence of uncommon harms.

13. Why This Trial Matters Statistically

This study illustrates a central issue in clinical-device research: a safety endpoint can be important even when the observed count is zero, but the interpretation depends on study size, follow-up, event definitions, and uncertainty. A zero count is an observation, not a demonstration that an event cannot occur. Without a confidence interval or fuller endpoint analysis, the precision of the result is not available from the registry record.

The design also matters. A single-group investigation can document the experience of patients treated with a device in a particular setting, but it cannot provide a like-for-like comparison. For researchers reading registry results, distinguishing descriptive safety evidence from comparative evidence prevents an observed outcome from being overstated.

The endpoint’s attribution requirement raises a further statistical and clinical question: whether an event was related to the device. The registry gives the endpoint wording but does not report how attribution was determined. Definitions and adjudication procedures can affect which observations count toward a device-related endpoint, so their absence limits independent interpretation.

Finally, this record shows why outcome timing and analysis details matter. The primary endpoint is during the procedure, while the study summary describes collection of data up to 30 days after surgery. The registry does not explain the other outcome measure, missing-data handling, or the analysis plan. Those details affect how completely readers can judge the safety record and the scope of the evidence. The trial is statistically informative as a documented single-group device investigation, while its registry record leaves important uncertainty about precision, attribution, and analysis.

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 most important design limitation is the absence of a comparator group. With a single group and no allocation to alternative care, the study cannot estimate a relative safety or performance effect. The results also cannot distinguish outcomes associated with the device from those related to the surgical procedures or other factors.

The registry records enrollment of 15 participants, but does not report the number included in each outcome analysis or whether any observations were missing. It does not provide a confidence interval for the serious adverse event endpoint. This restricts assessment of how precise the observed safety count is, especially for uncommon events.

The endpoint focuses on serious adverse events related to device use during the procedure. The registry does not describe the criteria for seriousness or relatedness, who assessed them, or whether assessment was independent. The summary states that data were collected up to 30 days post-surgery, but the adverse-event figures do not have a clearly stated timeframe, and the relationship between that collection period and the procedure-only endpoint is not explained.

The record lists 11 participants affected by other adverse events but does not report their terms, severity, timing, or device relationship. It gives limited information about the second outcome measure and the single recorded analysis. The statistical analysis plan, protocol sample-size justification, interim-analysis plan, missing-data methods, and analysis populations are not reported in the registry record. These limitations mean that the posted results are best interpreted as a narrow descriptive account rather than a complete evaluation of safety or performance.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP — NCT06119568.
• Registry record last updated 2026-07-20; status last verified 2026-07.
• Results first posted 2026-07-20.
• 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.

18. Record Summary

NCT06119568, HYROS-PRnP, is a completed single-group investigation of the Bitrack System and its compatible ESE/NESE instruments and accessories in robot-assisted radical or simple nephrectomy, partial nephrectomy, or radical prostatectomy. The registry lists 15 participants enrolled, allocation as NA, and no masking. The study began on 2023-11-01 and reached primary completion on 2024-04-01.

The primary endpoint is the number of serious adverse events related to device use during the procedure. The posted safety figures list 0 participants affected by serious adverse events, 11 affected by other adverse events, and 0 deaths. The registry summary describes data collection up to 30 days after surgery, but does not detail the timeframe for all safety figures or the endpoint adjudication methods.

No comparator-based estimate, confidence interval, or detailed analysis plan is reported in the registry record. The findings are descriptive and should not be read as proof of zero risk or as a comparison with another surgical approach.