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 HYbrid RObotic Surgery in Urology (NCT05864040), a na na study. The primary outcome is Safety of the Bitrack System.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05864040 |
| Phase | NA |
| Condition | Nephrectomy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rob Surgical Systems S.L. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients scheduled for laparoscopic radical or simple nephrectomy. The eligibility description specifies adults between 18 and 90 years old who provided informed consent before study-related procedures and were able and willing to comply with study requirements. The registry does not report the enrolled participants' ages or other baseline characteristics, so the eligibility description should not be read as a description of the observed group.
Intervention
The intervention was a laparoscopic radical or simple nephrectomy assisted by the Bitrack System. The registry describes the system as a surgical robot for urological procedures and notes that it requires single-use Electro-Surgical Endoscopic and Non-Electro Surgical Endoscopic instruments. The investigation concerned the device and its corresponding instruments in this surgical setting.
Comparator
There was no separate comparator group in this single-group study. The allocation field is recorded as not applicable, and the registry does not describe a randomized or controlled comparison. The results therefore describe the participants treated with the system; they do not estimate a difference between Bitrack-assisted surgery and another surgical approach.
Primary question
The primary question was whether procedure-related adverse events and serious adverse events occurred during the procedure and through 30 days post-procedure. This is an early feasibility and safety question about use of the system in the specified nephrectomy procedures. It is not a comparative effectiveness question, and the registry does not report a planned statistical test comparing treatments.
The registry identifies nephrectomy as the condition and describes the study as an early feasibility clinical investigation of a new medical device. Its primary outcome is a count of adverse events, rather than a measure of comparative benefit. For interpretation, the key distinction is between the stated safety question and conclusions the single-group design cannot answer: the record can describe whether events were recorded in this group, but it cannot establish how event frequency compares with another technique or device.
3. Trial Design
NCT05864040, titled HYbrid RObotic Surgery in Urology, is registered as a completed, single-group study sponsored by Rob Surgical Systems S.L. The registry gives a start date of 2023-04-11 and a primary completion date of 2023-05-30. Phase and allocation are recorded as not applicable, and masking is listed as none. These entries describe a non-masked, non-comparative investigation rather than a randomized trial.
The brief description characterizes the study as an early feasibility clinical investigation of the Bitrack System and its corresponding Electro-Surgical Endoscopic and Non-Electro Surgical Endoscopic instruments. The procedure under study is robot-assisted laparoscopic radical or simple nephrectomy. The listed intervention is the Bitrack System-assisted procedure, and the arm description concerns subjects undergoing that surgery. The eligibility description refers to adults between 18 and 90 years old who consented and could comply with study requirements; it does not give observed demographic characteristics.
Enrollment is recorded as 3. The adverse-event results list 3 participants at risk for serious events and 3 at risk for other adverse events. These figures describe the recorded safety group; they do not create a comparison group. Because the design has one group, any observed event count is descriptive. It cannot by itself separate outcomes associated with the device from outcomes associated with surgery, underlying health, or other factors.
The registry lists 14 outcome measures and 0 analyses. It does not report a detailed statistical analysis plan, a sample-size justification, interim analyses, or a protocol-based account of the analysis population. Such information should not be inferred from the study's completed status or from the small enrollment. The design is best understood as an early feasibility investigation with a short, specified safety observation period, not as a trial designed to support a controlled estimate of treatment effect.
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 | Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy |
|---|---|
| STARTED | 3 |
| COMPLETED | 3 |
| 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 | Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy |
|---|---|---|
| Participants analysed | 3 | |
| Age, Customized: Subject 01 | years | 53 |
| Age, Customized: Subject 02 | years | 49 |
| Age, Customized: Subject 03 | years | 37 |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 2 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Safety of the Bitrack System, measured over 30 days post-procedure.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | adverse events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of adverse events relevant to safety of the Bitrack System. The description specifies procedure-related adverse events, defined as adverse events related to the investigational procedure, and serious adverse events. Events were to be assessed during the procedure and through 30 days post-procedure for enrolled patients undergoing robot-assisted laparoscopic radical or simple nephrectomy.
A count endpoint records how many participants experienced an event, rather than measuring the size of a continuous change such as a laboratory value. Such outcomes are useful in early feasibility work because they make observed safety events a central focus. A count alone, however, does not explain the event's severity, timing, duration, or relationship to the device unless those details are separately reported. The registry's listed primary description does not give event-level narratives.
The recorded adverse-event figures list 0 participants affected by serious adverse events and 0 affected by other adverse events among 3 participants at risk in each category. No deaths are recorded. These are descriptive results for the registered group and observation period. The record does not report an interval estimate for the primary endpoint or a comparative analysis. With a small group, a zero count is compatible with substantial uncertainty about the event frequency that might be seen in a broader population. It should not be interpreted as proof that the risk is absent.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports enrollment of 3 and a single study group receiving Bitrack System-assisted laparoscopic radical or simple nephrectomy. For the adverse-event results, 3 participants were listed as at risk for serious events and 3 for other events. The figures record 0 participants affected in each category and 0 deaths. These are the central observed safety counts in the registry record.
Those observations are descriptive, not comparative. There is no separate control group, and the registry does not report random allocation. Consequently, there is no within-record estimate of how outcomes might differ under another device, surgical technique, or usual care. A single-group result can describe what was observed during use in the enrolled participants, but it cannot establish that the device caused or prevented an outcome. Nor can a lack of recorded events establish that a procedure is risk-free.
General statistical interpretation: an event count from a small group has limited precision, especially when the observed count is zero. A confidence interval, when reported, expresses uncertainty around an estimated quantity under specified statistical assumptions. No confidence interval for the primary safety outcome is reported in the registry record. Without an interval or a larger comparative dataset, the observed zero counts leave a wide range of plausible event frequencies unresolved. The absence of an interval is not evidence that the estimate is precise.
The study's stated purpose is to evaluate safety and feasibility. The results described in the registry speak most directly to the recorded adverse-event categories, not to every aspect of feasibility. Secondary outcomes include tissue damage, instrument performance, blood loss, transfusion rates, use of hemostatic agents, operative time, and post-operative pain. Results for these secondary outcomes are not reported in the registry record. Their inclusion as outcome measures does not show what was observed.
The registry lists 14 outcome measures and 0 analyses. That combination does not provide enough detail to reconstruct an inferential analysis or identify which outcomes were analyzed together. A p-value, adjusted estimate, or prespecified model is not reported in the registry record. There is therefore no basis for characterizing the results as statistically significant or nonsignificant. The completed status indicates the registered study is marked completed; it does not supply missing outcome details or alter the limits of the design.
Planning calculations associated with a small observed effect should also be read cautiously. The registry's stated assumptions describe illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are planning illustrations, not observed power and not evidence of a comparison performed in this single-group study. The posted information does not provide a controlled treatment-effect estimate from which to draw comparative conclusions. Overall, the safety counts document no recorded affected participants in the listed categories, while the small, uncontrolled study and absent precision estimates leave uncertainty about broader safety and comparative performance.
9. Statistical Methods Explained
What does a single-group design estimate?
General explanation: a single-group study describes outcomes among participants exposed to the intervention under study. It can document observed events and may help identify practical issues during early use. Without a comparator, it does not directly estimate a treatment contrast. In a controlled study, the contrast is the difference between outcomes under alternative groups or strategies. Here, allocation is recorded as not applicable and the model as single group, so no such contrast is reported.
That distinction matters even when event counts are easy to understand. If no event is recorded, the observation is that no event was recorded in the observed group during the recorded period. The observation does not reveal what would have happened to those same participants under a different procedure. It also does not rule out uncommon events that might arise in a larger group or with longer follow-up. The registry's primary observation period ends 30 days post-procedure.
Why is the primary endpoint a count?
General explanation: count-based safety outcomes describe whether events occurred and how many participants were affected. They can be appropriate when the question is focused on harms rather than on an average change in a measurement. The registry describes an adverse-event count and distinguishes procedure-related adverse events and serious adverse events in the endpoint description. The posted adverse-event results separately list serious and other adverse-event categories. Counts do not automatically describe event seriousness, duration, or attribution; those aspects require definitions and event-level reporting.
Participant counts and event counts are not always interchangeable. A participant could in principle experience more than one event, whereas a count of participants affected records whether a participant had at least one event in a category. The registry's adverse-event result is expressed as participants affected and participants at risk. It does not provide event narratives or a fuller account of repeated events. The reported zero affected participants should therefore be read according to the displayed participant-level categories rather than as a comprehensive account of all possible clinical experiences.
What does uncertainty mean when the count is zero?
General explanation: an estimate based on a small sample is imprecise because each observation carries substantial influence. When an event is not observed, the data do not demonstrate that the underlying event probability is zero. A confidence interval is a range of values compatible with the data under a chosen method and its assumptions. It communicates uncertainty; it is not a guarantee that the true value lies within the interval. The registry record does not report a confidence interval for the safety outcome, so a numerical precision estimate cannot be attributed to this result.
A zero count is also not a test result. Statistical significance requires a defined inferential question, a model or test, and a comparison or reference value. The registry does not report a primary-outcome analysis or a p-value. It would be inappropriate to label the result significant, nonsignificant, or conclusive on the basis of the count alone. The listed 0 analyses reinforces that inferential results are not reported in the record.
Why can over-dispersion matter?
General explanation: some count outcomes vary more than a simple statistical model expects. This is called over-dispersion. It can arise when participants differ in underlying risk or when events cluster, for example, and it can make uncertainty larger than a basic model suggests. Models for event counts may need to account for that extra variability. This general issue does not establish that over-dispersion occurred in this study. The registry does not report a count model, distributional assessment, or analysis plan that would show how count variability was handled.
There is also a distinction between a count of affected participants and a rate. A rate requires a time-at-risk denominator or another exposure measure, together with a clearly defined event count. The registry gives a follow-up window and participants at risk, but does not report a rate analysis. The observed participant counts should not be recast as a rate or extrapolated beyond the stated follow-up period.
How should planning illustrations be read?
The planning assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. General explanation: a sample-size calculation asks how many participants a future study might require to detect a specified effect under assumptions about the design and variability. The answer depends on the effect size, significance threshold, desired power, outcome type, allocation, and analysis method. Changing those assumptions can change the resulting planning estimate.
These calculations are planning illustrations, not observed power. Observed power is not a substitute for interpreting an estimate and its uncertainty after a study is complete. The trial itself is listed as single group, so a two-arm planning scenario must not be mistaken for a randomized comparison conducted in this study. For non-time-to-event outcomes, the stated convention is participants per arm; time-to-event planning uses a total number of events. No numerical planning row or effect fraction is reported in the registry record described by the results, so no specific sample-size value or assumed effect should be inferred.
What can be concluded from the registered methods?
The registry identifies a safety-focused endpoint, a 30-day post-procedure observation period, and a single-group model. It does not report an inferential model, confidence interval, missing-data method, or detailed statistical analysis plan. General statistical concepts can explain why those details matter, but they cannot fill gaps in the registered methods. Interpretation should remain anchored to the descriptive participant counts and the limited scope of the recorded design.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures, including the primary safety outcome and secondary outcomes covering adverse events, tissue damage, instrument performance, blood loss, transfusion rates, hemostatic-agent use, operative time, and post-operative pain. Considering multiple outcomes can raise a multiplicity issue: when many statistical tests are conducted, the chance of at least one apparently unusual result can increase. General statistical approaches may control that risk or distinguish confirmatory outcomes from exploratory ones. The registry does not report a multiplicity strategy, and it lists 0 analyses, so no adjustment or hierarchy should be assumed.
Outcome measures are not the same as analysis results. The presence of a measure in the registry does not show that complete data were collected or analyzed, and the stated count of measures does not reveal which outcomes have posted findings. Results for the listed secondary outcomes are not reported in the registry record. No interpretation of their direction, magnitude, or precision is possible from their names alone.
Missing-data handling is not reported in the registry record. The record does not describe how missing observations were defined, whether any outcomes were unavailable, or whether an imputation or sensitivity analysis was planned. It also does not report a detailed analysis population, such as how participants would be included if they did not complete follow-up. These details matter because exclusions and missing observations can affect estimates and their uncertainty.
The registered status is completed, but that status does not establish that all outcome data are complete or that a particular analysis population was used. The record does not report interim analyses, a sample-size justification, or a detailed analysis plan. Statistical conclusions should therefore be restricted to the descriptive adverse-event figures that are recorded, without assuming unreported methods for multiplicity or missing data.
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 |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | 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 |
|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | 0 of 3 |
The registry reports 0 participants affected by serious adverse events among 3 at risk and 0 participants affected by other adverse events among 3 at risk. Deaths are recorded as 0. These figures describe the registered safety categories for the study group; they are not evidence from a comparison with another surgical approach.
A zero observed count means no affected participants were recorded in that category during the stated observation context. It does not prove that the underlying risk is zero. General statistical explanation: with a small group, uncommon events may not appear in the observed sample, and the resulting uncertainty can remain substantial. A confidence interval can make that uncertainty more explicit, but no interval for these figures is reported in the registry record.
The primary endpoint description focuses on procedure-related adverse events and serious adverse events during the procedure and through 30 days post-procedure. The adverse-event results give serious and other categories, but the record does not provide event-level descriptions or a more detailed breakdown of procedure-relatedness. The figures should be read as a concise record of reported participant-level counts, not as a complete account of event severity, timing, or causality.
12. What the Result Does, and Does Not, Mean
The result establishes a limited descriptive fact: the registry records no participants affected by serious adverse events and no participants affected by other adverse events in the reported safety group, with no deaths recorded. The observation period specified for the primary safety outcome extends through 30 days post-procedure. The enrollment is recorded as 3, and the adverse-event results list 3 at risk for each category.
That observation does not establish that the Bitrack System is free of risk. A small single-group experience cannot precisely characterize uncommon events, and there is no comparator to show whether the recorded outcomes differ from those under another surgical approach. A zero count is an observation, not proof of a zero underlying event probability. The registry does not report a confidence interval or other precision estimate for the primary outcome.
The study description frames the investigation as an early feasibility evaluation of the device and its corresponding instruments in robot-assisted laparoscopic radical or simple nephrectomy. The safety counts address one part of that purpose. They do not, by themselves, demonstrate technical feasibility, operative performance, or comparative clinical benefit. Although the registry lists secondary measures such as blood loss, operative time, instrument performance, tissue damage, transfusion rates, use of hemostatic agents, and post-operative pain, their results are not reported in the registry record.
The completed status and the recorded event counts should not be treated as evidence that all questions have been resolved. The registry does not report a comparative analysis, a statistical test, or a detailed account of missing observations and analysis populations. It also does not report results that would support conclusions about the frequency of events beyond the observed group and follow-up period.
The appropriate reading is therefore narrow: the posted data describe no recorded affected participants in the reported adverse-event categories during this small feasibility study. They do not estimate how outcomes compare with another procedure, establish long-term safety, or show the results of the other listed outcomes. Those broader questions remain unanswered by the information reported in the registry record.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the difference between documenting an early clinical experience and estimating a comparative treatment effect. The registry describes a single group receiving a device-assisted procedure and reports a small enrollment. That design can contribute descriptive safety information, but it cannot distinguish outcomes under the device from outcomes that might have occurred under a different surgical approach.
Zero-event findings are especially easy to overinterpret. A zero count is clear as an observation, yet it can coexist with substantial uncertainty about the event frequency in a broader population. General statistical reasoning therefore calls for attention to sample size, observation time, and interval estimates, not simply the presence or absence of an event. No interval estimate is reported for the primary safety outcome in the registry record.
The registered study also provides a useful example of the difference between an outcome being listed and an outcome having results. The record names several secondary measures, but their findings are not reported. Likewise, the listing of 14 outcome measures alongside 0 analyses does not provide a statistical analysis plan or evidence that multiplicity was addressed. A measure's inclusion does not establish what its data showed.
Finally, the planning assumptions should be kept separate from the completed study's evidence. Illustrations using a two-arm allocation and a normal approximation concern potential future planning, not a comparison conducted in this single-group investigation and not observed power. Keeping these distinctions clear helps readers avoid treating a feasibility record as a definitive assessment of safety or comparative effectiveness.
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 limitation is the single-group design. The registry does not describe a control group or randomized allocation, so the observed counts cannot estimate a difference between the Bitrack System-assisted procedure and another approach. No adjustment for differences between treatment groups is possible because a treatment comparison is not reported.
Enrollment is recorded as 3, and the safety results list 3 participants at risk in each adverse-event category. This small group limits how precisely the study can describe event frequency, particularly for uncommon events. The registry reports no confidence interval or other precision measure for the primary outcome. A lack of recorded events in this group does not exclude events in a larger or different population.
The primary safety observation period is specified through 30 days post-procedure. The record does not report longer-term safety results. It also does not give event-level narratives, detailed event timing, or a fuller breakdown of procedure-relatedness. This limits assessment of the nature of any events beyond the summarized categories.
Several secondary outcomes are listed, but their results are not reported in the registry record. Baseline characteristics of enrolled participants and a detailed analysis population are not reported there either. Missing-data procedures, a detailed statistical analysis plan, interim analyses, and a sample-size justification are also not reported in the registry record. The completed status cannot substitute for those details.
These limitations are specific to the information and design recorded for this investigation. They do not invalidate the reported descriptive counts, but they constrain what those counts can support: a limited account of recorded safety outcomes in the study group, rather than a precise or comparative estimate.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: HYbrid RObotic Surgery in Urology — NCT05864040.
- Registry record last updated 2025-03-21; status last verified 2025-03.
- Results first posted 2025-03-21.
- 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
NCT05864040, HYbrid RObotic Surgery in Urology, is a completed, single-group early feasibility clinical investigation sponsored by Rob Surgical Systems S.L. The registered intervention is Bitrack System-assisted laparoscopic radical or simple nephrectomy. Enrollment is recorded as 3, and the primary safety observation period extends through 30 days post-procedure.
The primary outcome concerns procedure-related adverse events and serious adverse events. The registry reports 0 participants affected by serious adverse events and 0 affected by other adverse events among 3 at risk in each category; deaths are recorded as 0. The study has no reported comparator, and the registry lists 14 outcome measures and 0 analyses. Findings for secondary outcomes and detailed inferential methods are not reported in the registry record.