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 superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology (NCT03585959), a na na study. The primary outcome is Confirm the Location Accuracy of the Local Registration Feature.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03585959 |
| Phase | NA |
| Condition | Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medtronic - MITG |
| Results posted | Yes |
2. Clinical Question
Population
Subjects undergoing lung lesion biopsy were included in a post-market feasibility study. The registry lists lung cancer as the condition and records enrollment of 50. The primary-endpoint description focuses on technically successful cases and notes that some cases could not be analyzed or had data from only one of the specified imaging assessments. The full population description is not reported in the registry record.
Intervention
The study evaluated the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology. The registry describes an electromagnetic navigation bronchoscopy system with enhanced three-dimensional fluoroscopy and an integrated real-time local registration feature. The stated purpose was to confirm clinical accuracy.
Comparator
There was no separate comparator group: the study is listed as single-group, with allocation recorded as NA. It therefore does not provide a like-for-like comparison between the device and another device, procedure, or control group.
Primary question
Could the system place the center of its virtual navigation target over the intended target lesion, as confirmed by cone-beam computed tomography? A case counted as a primary-endpoint success when the virtual target had more than 0% overlap with the lesion in the three-dimensional assessment. The registry describes the endpoint but does not report the resulting success count or percentage.
Statistically, this is a feasibility and location-accuracy question rather than a comparative treatment-effect question. The primary endpoint is based on a binary classification of overlap: any overlap above the stated threshold is success, while no overlap is not. The registry’s endpoint unit is participants, and its endpoint description also refers to a percentage of cases. Without a reported numerator and denominator for the analyzed endpoint, the observed accuracy cannot be quantified from the record.
3. Trial Design
The registry describes a completed post-market feasibility study of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology. Its listed design is single-group, with no masking and allocation recorded as NA. Enrollment is recorded as 50. The study start date is 2018-08-03, and primary completion is recorded as 2019-02-13. The phase is listed as NA.
The intervention was a device. The arm description identifies an electromagnetic navigation bronchoscopy system with enhanced three-dimensional fluoroscopy, intended to improve lesion visibility and compensate for CT-to-body divergence. It also describes real-time local registration that allows the operator to update catheter position. The arm-description text in the registry record is incomplete, so further operational details are not reported in the registry record.
The primary endpoint was evaluated on the day of the procedure. The registry states that the location-accuracy assessment was performed in technically successful cases, defined as cases with local registration complete. The described confirmation method was cone-beam computed tomography (CBCT), with overlap assessed in three dimensions. The study also lists secondary measures covering technical success, catheter location, procedure and fluoroscopy times, tissue-sample adequacy, and a histopathological call based on ROSE when applicable. Numerical results for these measures are not reported in the registry record.
A single-group design can describe outcomes observed while using the device, but it cannot separate the device’s contribution from other influences through a concurrent randomized comparison. This distinction matters when interpreting accuracy and feasibility results: they describe the recorded experience in the assessed cases, not a comparative estimate against an alternative. The registry lists 17 outcome measures and 0 analyses. A statistical analysis plan, formal hypothesis-testing strategy, and details of any planned interim analyses are not reported in the registry record.
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 | Fluoroscopic Navigation Arm |
|---|---|
| STARTED | 50 |
| COMPLETED | 47 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Fluoroscopic Navigation Arm |
|---|---|
| Physician Decision | 1 |
| Unsuccessful Procedure | 2 |
Analysis population for the primary outcome, as defined in the registry: 47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group.
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: All enrolled subjects were underwent baseline analysis.
| Characteristic | Unit | Fluoroscopic Navigation Arm |
|---|---|---|
| Participants analysed | 50 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 12 |
| Age, Categorical: >=65 years | Participants | 38 |
| Age, Continuous | years | 69.8 (SD 7.7) |
| Sex: Female, Male: Female | Participants | 35 |
| Sex: Female, Male: Male | Participants | 15 |
| Race/Ethnicity, Customized: Caucasian | Participants | 43 |
| Race/Ethnicity, Customized: Black of African American | Participants | 5 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 2 |
| Region of Enrollment: United States | participants | 50 |
| Medical History: Chronic Obstructive Pulmonary Disease (COPD) | participants | 31 |
| Medical History: Tobacco Use | participants | 44 |
| Lesion Characteristics: Lesion < 20 mm | lesion | 30 |
| Lesion Characteristics: Upper Lobe Location | lesion | 32 |
| Lesion Characteristics: Pure to mostly solid (Suzuki Class 5 or 6) | lesion | 49 |
| Lesion Characteristics: Bronchus Sign Present on CT | lesion | 26 |
6. Primary Endpoint
The registry lists the primary outcome as Confirm the Location Accuracy of the Local Registration Feature, measured over day of procedure.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint concerns whether the system’s virtual navigation target was positioned over the intended lung lesion. The registry defines the target as the center of the virtual navigation target, described as a green ball, and identifies CBCT as the confirmation method. Overlap was assessed in three dimensions using X, Y, and Z coordinates. Any case with more than 0% overlap was classified as a primary-endpoint success.
This endpoint converts a spatial assessment into a binary outcome: a case either crosses the specified overlap threshold or does not. Such a classification can make a technical result easier to summarize as a count or proportion. It also makes the threshold important to interpretation. A success under this definition indicates some overlap, not a particular degree of overlap or a measure of how close the target center was to the lesion center. The registry does not report additional thresholds or a graded accuracy measure.
The endpoint is described as being evaluated among technically successful cases, meaning cases with local registration complete. The registry reports 47 technically successful cases, then notes that 4 could not be analyzed because of inadequate video recording. It further states that, from 43 cases, 2 had data only from FNAV/CBCT 1 before correction of catheter location and 2 had data only from FNAV/CBCT 2 after correction. The continuation of this population description is incomplete in the registry record. The number of cases included in the final primary-endpoint calculation and the number meeting the success definition are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry record explains how the primary endpoint was defined but does not report its numerical result. It therefore does not establish, from the available record, how many assessed cases met the overlap criterion or what proportion did so. A description of an endpoint is not evidence of the observed endpoint value. Any interpretation of the study’s location accuracy must remain at the level of the measurement method and the case flow information that is recorded.
The recorded case flow also matters. The endpoint was intended for technically successful cases, and the registry reports 47 such cases. It then records 4 cases that could not be analyzed because of inadequate video recording. Among 43 cases, 2 had data only from the assessment before catheter-location correction and 2 had data only from the assessment after correction. The remaining details of the analysis population are cut off. Because the record does not fully state which cases contributed to the endpoint, the applicable denominator cannot be reconstructed from the text.
That missing denominator is important for a binary endpoint. A count of successes alone would not fully characterize accuracy without knowing how many cases were evaluated; a proportion likewise needs both a numerator and denominator. Precision would ordinarily be conveyed with an uncertainty interval around the estimated proportion. Such an interval indicates the range of values reasonably compatible with the observed data under the chosen method. Neither the primary result nor its uncertainty interval is reported in the registry record.
The design also sets limits on what can be inferred. This is a single-group study, not a randomized comparison. Even if the primary endpoint result were available, it would describe the observed classification under the study’s assessment process; it would not by itself estimate a difference from another navigation system or procedure. There is no concurrent control group described, and no allocation comparison is available.
The registry lists 17 outcome measures and 0 analyses. This does not supply a basis for judging how outcomes were prioritized, whether statistical testing was performed, or how any multiplicity was handled. The statistical analysis plan is not reported in the registry record. Accordingly, the record supports a description of the intended accuracy measure and selected case-flow details, but not a numerical conclusion about the endpoint’s observed accuracy, precision, or comparative performance.
9. Statistical Methods Explained
What does the primary endpoint classify?
The primary endpoint is a binary case-level measure. The registry defines success as any overlap greater than 0% between the virtual navigation target and the lesion, assessed in three dimensions and confirmed by CBCT. In general, a binary endpoint reduces each assessed case to one of two categories. This can make an outcome straightforward to count, but it also discards detail: cases with small and larger amounts of overlap can both meet the same success definition. The registry does not report a more graded measure alongside this threshold.
Why does the denominator matter?
A binary outcome is commonly summarized by reporting both the number of cases meeting the definition and the number assessed. The resulting proportion conveys the observed frequency in that analysis population. These quantities must refer to the same population and endpoint definition. Here, the registry describes 47 technically successful cases, 4 that could not be analyzed because of inadequate video recording, and partial data availability for some cases among 43. It does not report the final analyzed denominator or the endpoint success count. Those missing details prevent a reader from recovering the primary result from the registry text.
How should uncertainty be understood?
In general, a confidence interval expresses sampling uncertainty around an estimate, such as an observed proportion. It is not a guarantee that the true value lies within the interval, and its interpretation depends on the statistical method and assumptions. For a binary endpoint, the interval’s width is influenced by the number of observations and by the observed proportion. No primary-endpoint estimate or confidence interval is reported in the registry record, so the precision of the location-accuracy estimate cannot be assessed from the record.
What does a single-group design allow?
In general, a single-group study can describe what was observed among participants assessed while using an intervention. Without a concurrent comparison group, it does not provide a randomized estimate of how outcomes differ from those under an alternative. Differences across settings or populations cannot be attributed to the intervention by design when there is no such comparator. For this study, the record identifies a single group and allocation as NA; it does not describe a control arm.
Why distinguish technical success from endpoint success?
The registry makes technical success a condition for primary-endpoint evaluation: cases were considered technically successful when local registration was complete. That is distinct from the primary success definition, which requires overlap between the virtual target and lesion. These are different stages of outcome assessment. A case may be eligible for the location-accuracy assessment because local registration was complete, while the overlap classification is separately determined using CBCT. The record does not report the complete counts at each stage or the final endpoint result.
How should missing assessment data be considered?
In general, missing outcome information can affect interpretation when cases without usable measurements differ from those with complete measurements. Excluding cases with unavailable measurements may change the group represented by the calculated result. A clear report ordinarily identifies how many cases were eligible, how many were analyzed, why observations were unavailable, and how missing outcomes were handled. Here, inadequate video recording is identified for 4 cases, and the record describes partial assessment availability for additional cases. The remaining population-description text is incomplete, and a missing-data method is not reported in the registry record.
What can be inferred from the listed analysis count?
The registry lists 17 outcome measures and 0 analyses. This is a record of listed outcomes and analyses, not a substitute for a statistical analysis plan. In general, a prespecified analysis plan can clarify the analysis population, endpoint derivation, treatment of missing data, and planned uncertainty or hypothesis-testing procedures. Those details are not reported in the registry record. The record therefore does not establish whether the displayed outcome definitions were accompanied by a prespecified analysis strategy.
What is the role of planning illustrations?
In general, sample-size calculations describe how much information a future study might need under stated assumptions. The registry record’s stated illustration assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a fraction of an observed effect. For time-to-event outcomes, the description refers to total events; for other outcomes, it refers to participants per arm. These are planning concepts, not observed study results or evidence of the design used for this single-group study. The record does not report a sample-size justification for the trial itself.
Over-dispersion is a general issue for count outcomes when variation exceeds what a simple model assumes; accounting for it can affect uncertainty estimates. The primary endpoint is described as a binary classification, not a count rate, and no model-based analysis details are reported. A reader should not infer a particular statistical model, adjustment, or inferential procedure from the endpoint description alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures, including technical success and failure, investigator confirmation of catheter location, procedure and fluoroscopy times, tissue-sample adequacy, and a histopathological call based on ROSE when applicable. It lists 0 analyses. The record does not report how these measures were prioritized for statistical testing, whether formal hypothesis tests were conducted, or whether any adjustment for multiple comparisons was planned or used. Without an analysis plan and numerical outcome results, the impact of multiplicity cannot be assessed.
Missing assessment information is relevant to the primary endpoint. The registry reports 47 technically successful cases and says 4 could not be analyzed because of inadequate video recording. It then describes 43 cases, with 2 having data only from FNAV/CBCT 1 before catheter-location correction and 2 having data only from FNAV/CBCT 2 after correction. The population description is incomplete after that point. The final number included in the endpoint analysis and the handling of partial or unavailable assessments are not reported in the registry record.
In general, a complete analysis description identifies the population used for each outcome and explains how missing observations were treated. This matters because an estimate based only on cases with usable data describes those assessed cases; it may not represent cases with unavailable data if the groups differ. The record does not report whether missing outcomes were imputed, excluded, or handled using another method. It also does not report sensitivity analyses that might examine the effect of missing information.
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 |
|---|---|---|---|
| Fluoroscopic Navigation Arm | 1 | 50 | 2.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Fluoroscopic Navigation Arm | 0 of 50 |
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 |
|---|---|
| Fluoroscopic Navigation Arm | 7 of 50 |
Most frequent serious adverse event terms
| Event term | Organ system | Fluoroscopic Navigation Arm |
|---|---|---|
| Infection | Infections and infestations | 1 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fluoroscopic Navigation Arm |
|---|---|---|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 3 of 50 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 50 |
| Dizziness | Nervous system disorders | 1 of 50 |
| Urinary Retention | Renal and urinary disorders | 1 of 50 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 1 of 50 |
Serious events with the highest arm-level rate: infection (2.0%).
The registry reports safety figures for the Fluoroscopic Navigation Arm, with 50 at risk for serious adverse events and 1 affected. It records 50 at risk for other adverse events and 7 affected, and reports 0 deaths. The most frequently listed serious adverse-event term is Infection, at 2.0%.
These figures are descriptive counts from the registry record. The record does not provide further detail about event severity, timing, relationship to the device or procedure, or how events were classified. The listed serious-event term should not be interpreted as evidence of causation. The record also does not explain whether individual participants could contribute to more than one event category, so the categories should not be combined or treated as mutually exclusive.
Safety counts describe events recorded in this study group; they do not establish a comparison with another intervention or the frequency expected in a different population. The registry does not report a comparator group. The adverse-event figures should therefore be read as descriptive information in the context of this single-group study, not as a comparative estimate.
12. What the Result Does, and Does Not, Mean
The study was designed as a post-market feasibility evaluation of location accuracy using a navigation system with fluoroscopic navigation technology during lung lesion biopsy. The primary endpoint definition is explicit about the confirmation method and success threshold: CBCT was used to assess three-dimensional overlap, and any overlap greater than 0% counted as success. The registry also records that technical success required completion of local registration for primary-endpoint evaluation.
However, the registry record does not report the numerical primary-endpoint result. It gives no success count, analyzed denominator, estimated percentage, or uncertainty interval. Consequently, the record cannot establish the observed frequency of successful overlap or how precisely that frequency was estimated. The partial information about technical success and unavailable or incomplete video assessments does not fill in those missing outcome quantities.
Even a fully reported single-group accuracy result would answer a descriptive question about cases assessed under the study conditions. It would not, on its own, demonstrate that the system performs better than another device or procedure. No comparator group is described, and allocation is listed as NA. Nor does the endpoint definition quantify the degree of overlap beyond the threshold classification. A classification just above the threshold and a much larger overlap would both be successes under the stated rule.
The record also lists secondary outcome topics and safety counts, but numerical secondary-outcome results are not reported in the registry record. The safety information is descriptive and does not establish that events were caused by the device. The study’s design and the incomplete outcome reporting therefore support a limited interpretation: the record explains the feasibility and accuracy question, how the primary outcome was defined, and some case-flow and safety information. It does not provide enough primary-outcome information to quantify location accuracy or compare it with an alternative.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between a measurement rule and a measured result. A detailed endpoint definition helps readers understand what success means: the virtual target had to overlap the lesion by more than 0%, with the assessment confirmed by CBCT in three dimensions. But a transparent rule cannot replace the observed count, denominator, and uncertainty. Without those results, the central accuracy question remains numerically unanswered in the registry record.
Case flow is also statistically consequential. The primary endpoint was restricted to technically successful cases, while the record separately notes cases without analyzable video and cases with data from only one of two described assessments. These distinctions affect which cases can contribute to an endpoint estimate. Complete reporting of the analysis population and missing-data handling is therefore essential to understanding what any reported proportion represents.
The single-group design further defines the scope of inference. It can describe outcomes in the study group, but it cannot provide a randomized comparison with another approach. This distinction prevents a feasibility or accuracy measure from being mistaken for comparative evidence. The registry’s list of multiple outcome measures also makes it important to know which analyses were planned and how they were interpreted; those statistical details are not reported.
For clinical researchers and statisticians, the record illustrates why endpoint definitions, denominators, missingness, and design must be read together. They determine not just how an outcome is calculated, but what population and question the result can address. Here, the definition and some case-flow details are available, while the primary numerical outcome and its precision are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation is that the registry record does not report the primary endpoint’s numerical result. The success count, analysis denominator, percentage, and uncertainty interval are all absent. As a result, the stated location-accuracy question cannot be answered quantitatively from the record.
The primary endpoint was evaluated among technically successful cases, rather than being described for all enrolled cases. The registry reports 47 technically successful cases, 4 that could not be analyzed because of inadequate video recording, and partial assessment availability for some of the 43 cases mentioned afterward. The full population description is incomplete. The final analysis population and the treatment of cases with missing or partial data are not reported in the registry record.
The single-group design has no comparator group, so it cannot support a randomized comparison with another system or procedure. The registry lists allocation as NA and masking as NONE. A statistical analysis plan, including any model, uncertainty method, or missing-data procedure, is not reported. The record lists 17 outcome measures and 0 analyses, leaving multiplicity handling and the analysis hierarchy unclear.
The device-arm description is truncated, and the registry’s primary population description is also incomplete. Numerical results for the listed secondary outcomes are not reported in the registry record. The adverse-event figures are descriptive, with no additional information on event timing, attribution, or classification posted in the record. These limitations mean that the available information describes study intent, the endpoint rule, selected case-flow details, and safety counts, but not the complete evidence needed to assess the observed primary outcome.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology — NCT03585959.
- Registry record last updated 2020-04-29; status last verified 2020-04.
- Results first posted 2020-04-07.
- 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
The registry record describes a completed, single-group post-market feasibility study of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy. Enrollment is recorded as 50. The study started on 2018-08-03, with primary completion on 2019-02-13. Phase and allocation are listed as NA, and masking is listed as NONE.
The primary endpoint assessed whether the virtual navigation target overlapped the intended lesion, confirmed by CBCT. Any overlap greater than 0% counted as success, and the endpoint was evaluated in technically successful cases. The registry reports 47 technically successful cases and partial information about cases that could not be analyzed or had incomplete assessment data. The primary success count, final analysis denominator, and uncertainty interval are not reported in the registry record.
The record lists 17 outcome measures and 0 analyses. It also reports 1 affected by a serious adverse event, 7 affected by other adverse events, and 0 deaths. These figures are descriptive; no comparator is reported.