Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories. (NCT05953363), a registered phase not stated study. The primary outcome is Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location.

2. Clinical Question

3. Trial Design

This was a multicenter, prospective, open-label, single-arm post-market study sponsored by Becton, Dickinson and Company. The registry describes an evaluation of BD NRFit™ spinal needles, spinal introducer needles and syringes used in an on-market fashion. Participants received the devices as part of routine medical care when they required them for a neuraxial procedure. The record lists anesthesia and analgesia as conditions.

The study began on 2023-07-24, reached primary completion on 2024-05-28, and has a COMPLETED status. Enrollment was 161. The record does not report the number of participating centers, the setting or location of those centers, or further eligibility details.

A single-arm design can describe observed outcomes among participants who received the devices, but it does not create a concurrent comparison group. The registry does not state an allocation method, and the record explicitly does not characterize the study as a randomized comparison. Consequently, the study design alone cannot separate device-related outcomes from other influences on the procedure or its result.

The registry lists 7 outcome measures and 0 analyses. The primary endpoint concerns successful needle placement, while a safety population is used for the adverse-event counts. Details about how participants entered each analysis population, how outcomes were collected across centers, and whether any protocol-defined analyses were planned 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.

Before assignment: In this post-market study, the choice of BD Spinal NRFit™ needle (gauge, length, tip type), BD Syringes NRFit™, BD Spinal NRFit™ needle set, and BD Spinal Introducer NRFit™ needle was at clinician discretion. A total of 161 subjects were enrolled to ensure a minimum of 150 received spinal anesthesia and were observed for 10 days post-procedure for adverse events/complications. A minimum of 50 subjects per tip type (Quincke and Whitacre) were included.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants in whom a spinal anesthesia procedure is attempted, regardless of success.

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 participants in whom a spinal anesthesia procedure is attempted, regardless of success.

6. Primary Endpoint

The registry lists the primary outcome as Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location, measured over During insertion procedure.

The primary endpoint is the rate of participants with successful placement of the BD spinal NRFit™ needle in the subarachnoid location during the insertion procedure. The registry defines success by a procedural observation: cerebrospinal fluid emerging spontaneously from the spinal needle hub. The endpoint population includes participants in whom spinal anesthesia was attempted, regardless of success.

This definition gives the endpoint a direct relationship to the intended placement step. In general, a clearly defined procedural endpoint helps readers understand what counts as an event and which participants belong in the denominator. It also makes the measure more interpretable than a vague judgment of success, although the registry does not report details about outcome adjudication, assessor training or handling of ambiguous observations.

The endpoint is titled as a rate, and its description refers to the percentage of participants meeting the definition. The listed measurement parameter is a count of participants. The registry record does not report the number meeting the definition, the number assessed for the outcome, or the resulting rate. Therefore, the endpoint definition can be described, but the observed placement result and its precision cannot be evaluated from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the single-arm design allow?

In general, a single-arm study observes outcomes in participants who receive the study intervention without assigning a separate concurrent group to another intervention. It can characterize what was recorded in the study population. It cannot, by itself, show how outcomes would have differed under another device or approach. Differences in participant characteristics, clinical circumstances, procedural practice and outcome recording may all affect observed results, and a single-arm design does not control those factors through random allocation.

This study is described as prospective, open label and post-market. Prospective collection means the study followed participants forward for its planned assessment, but the registry does not provide detailed collection procedures. Open-label means the study was not described as blinded. The record does not explain whether outcome assessors were independent or how the procedural endpoint was documented. Those omissions limit assessment of how consistently the outcome may have been observed.

How should the primary endpoint be understood?

The primary endpoint is a binary participant outcome: the participant either met the stated success definition or did not. In general, a binary endpoint can be summarized by a count and a proportion or rate, provided the numerator and denominator are known. Here, the criterion is spontaneous emergence of cerebrospinal fluid from the needle hub, and the target population is participants with an attempted spinal anesthesia procedure, regardless of success. The registry record does not report the observed count or denominator for this endpoint, so no rate can be interpreted.

A confidence interval is a range calculated from data using a statistical method. In general, it represents the precision of an estimate under that method and its assumptions; it does not guarantee that the true value lies in the interval. The registry record does not report a confidence interval for the primary endpoint. With no posted estimate or interval, the degree of uncertainty around placement success cannot be evaluated.

What do the analysis listings mean?

The registry lists 7 outcome measures and 0 analyses. This indicates that outcomes are named in the record, while no statistical analyses are listed there. The record does not report a model, adjustment strategy, hypothesis test, p-value or inferential estimate for the primary outcome. It also does not report whether any analyses were conducted outside the registry record.

In general, an analysis plan specifies how outcomes will be summarized or compared, how missing observations will be handled, and which assumptions will guide statistical inference. Such details help distinguish planned analyses from exploratory ones and clarify how reported results were obtained. The study’s statistical plan, including any prespecified hypotheses or interim analyses, is not reported in the registry record. No assumptions should be inferred from the design or from the absence of listed analyses.

How should the planning illustrations be read?

The planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These assumptions describe a hypothetical planning exercise, not the design of this single-arm study. The record does not report a randomized two-arm comparison, and the planning assumptions should not be mistaken for the trial’s own allocation or analysis plan.

For non-time-to-event outcomes, planning estimates are expressed as participants per arm for 80% power or another stated power target. Time-to-event calculations instead concern a total number of events. In general, these are sample-size planning quantities conditional on assumed effects and methods. They are not observed results and do not establish the power of a completed study. The planning illustrations are not evidence that the enrolled study had a particular probability of detecting an effect.

The illustrations are described as based on the observed effect, but the primary observed effect is not reported in the registry record. No numeric planning estimate should therefore be inferred from the registry entries. More generally, a sample-size calculation depends on the chosen effect size, significance level, power target, allocation, and statistical assumptions. Changing those inputs can change the required sample size; a planning calculation cannot substitute for outcome results.

Why does over-dispersion matter in general?

Over-dispersion occurs when observed variation is greater than a statistical model expects. For count outcomes, failing to allow for over-dispersion can make uncertainty appear too small and can lead to overly narrow intervals or misleading tests. This is a general consideration, not a reported feature of this study. The primary endpoint is a participant-level binary outcome, and the registry record does not report a model for it or identify over-dispersion as an issue.

For any analysis, interpretation depends on the population analyzed, outcome definition, missing-data approach and statistical method. The record provides the primary population definition and selected safety counts, but does not report the primary outcome result, inferential analysis, missing-data method or detailed analysis populations. Those missing details prevent a fuller assessment of precision and robustness.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures, but it does not report a multiplicity strategy. In general, when several outcomes or hypotheses are tested, the chance of at least one chance finding can increase if each is assessed without adjustment. Methods that control multiplicity can address this issue, but the appropriate approach depends on the planned hypotheses and their ordering. No such strategy, testing hierarchy or adjusted analysis is reported in the registry record. The record also lists 0 analyses, so there are no posted inferential results from which to assess how multiple outcomes were handled.

The primary endpoint population is defined as all participants in whom spinal anesthesia is attempted, regardless of success. However, the primary outcome denominator, missing observations and any exclusions are not reported. The registry does not describe an imputation method, a complete-case approach, or a sensitivity analysis for missing endpoint data. It is therefore not possible to assess whether missingness could have affected the placement result.

The safety counts are reported for a safety population of 153 at risk. The record does not explain how this population was defined or how it relates to enrollment of 161. The primary endpoint population and safety population have separate descriptions, but details on their membership and analysis rules are not reported. The registry also does not state whether the same population definitions were applied across all 7 outcomes.

In general, analysis-population definitions and missing-data rules are important because they determine which observations contribute to each estimate. Without the outcome denominator and handling rules, readers cannot reconstruct the primary rate or evaluate the potential effect of missing data. No assumptions about these methods are warranted from the registry record.

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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hypoaesthesia (0.7%).

The registry reports safety counts for a population of 153 at risk. It lists 1 serious adverse event and 14 other adverse events for that population, and reports 0 deaths. Hypoaesthesia is listed among the leading serious terms at 0.7%. These figures should be read as the counts and term information recorded in the registry, not as a comparison with another group.

The record does not provide event-level descriptions, timing, duration, severity grading beyond the serious classification, or an assessment of whether events were related to the devices or procedure. It also does not explain whether the other-event count represents participants or event occurrences, or whether an individual could contribute more than one event. Accordingly, the counts should not be interpreted as a complete account of each participant’s experience.

The safety denominator is not the enrollment figure, and the registry record does not explain the relationship between those populations. No rate calculations or comparisons are added to the posted counts. The figures describe the safety information recorded, but do not by themselves establish causation or support a comparative safety conclusion.

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

The study addresses a specific procedural question: how often participants had successful BD spinal NRFit™ needle placement according to the registry’s criterion of spontaneous cerebrospinal fluid emerging from the needle hub. It also records selected safety information. These features make the study relevant to describing post-market use in its study population, but the registry record does not include the primary success count or rate.

Without the primary result and its denominator, the central performance outcome cannot be quantified. Without an uncertainty interval or inferential analysis, its precision cannot be judged. The endpoint definition explains what would count as success; it does not show how often the criterion was met. The posted safety counts provide additional descriptive information, but they do not establish whether events were caused by the devices or procedure.

The single-arm, open-label design has no concurrent control group. It therefore cannot provide a controlled estimate of how results compare with another device or clinical approach. No randomized allocation is described, and the record does not report an allocation method. Results from this design should not be interpreted as a comparative effect.

In general, a study’s findings apply most directly to the participants and procedures represented in that study. The registry describes people receiving the devices as part of routine medical care, but does not report enough detail about centers, eligibility, or participant characteristics to assess how closely the study population resembles other settings. No broader generalization can be established from the registry information alone.

The record reports a COMPLETED study with enrollment of 161 and lists the study’s endpoint and safety information. Completion status does not mean that every outcome result or analysis is posted. The record’s 0 analyses and absence of a primary outcome estimate leave the main performance question unanswered in the posted results. Thus, the available information supports a description of design and selected safety counts, not a conclusion about comparative effects or the magnitude and precision of placement success.

13. Why This Trial Matters Statistically

This study raises a useful statistical distinction between having a clearly defined endpoint and having a reported result for that endpoint. The registry defines successful placement through an observable procedural sign and specifies the population in which the endpoint is intended to be assessed. Those definitions are essential for interpreting an outcome, but they do not replace the numerator, denominator and uncertainty estimate needed to understand the observed rate.

The single-arm, post-market design also illustrates the limits of descriptive evidence. Observed outcomes can provide information about device use in the enrolled population, but without a concurrent comparator they cannot establish how those outcomes differ from another approach. Open-label collection may also make consistent outcome assessment an important consideration; the record does not describe assessor procedures or blinding.

Reporting the analysis population is another key statistical issue. Enrollment is 161, while safety counts use a denominator of 153, and the relationship between those figures is not reported. The primary endpoint population is defined by attempted procedures, but its actual denominator is missing. Transparent population flow and missing-data information would help readers understand which observations inform each outcome.

Finally, the record lists 7 outcome measures and 0 analyses. This makes the distinction between outcomes named in a registry and analyses reported in a registry especially important. Without posted estimates, intervals or methods, readers cannot assess statistical precision, multiplicity handling or robustness. The study is statistically informative as an example of why endpoint definitions, analysis populations and complete results reporting must be considered together.

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 for interpreting performance is that the registry record does not report the primary outcome count, denominator, rate or precision estimate. The stated endpoint definition is clear, but no observed success result is available for quantitative interpretation. The record lists 0 analyses and does not provide a statistical model, p-value or confidence interval.

The single-arm design has no described comparator, and the allocation method is not stated. This limits interpretation to descriptive observations and prevents a controlled assessment against another device or procedure. The open-label design is reported, but outcome-assessment procedures, assessor independence and any safeguards against inconsistent classification are not described.

Although the study is multicenter, the number and characteristics of centers are not reported. Participant eligibility details and baseline characteristics are also not reported in the registry record. These omissions make it difficult to assess the range of clinical circumstances represented or how applicable the observed data may be elsewhere.

The primary endpoint population is defined by attempted spinal anesthesia, but its denominator and missing-data handling are not reported. The safety population is described as 153 at risk, while enrollment is 161; the relationship between the two is not explained. The registry also does not report detailed event-level information, event relatedness, or methods for collecting and classifying adverse events.

Finally, the record lists 7 outcome measures but does not report a multiplicity plan or analysis hierarchy. The protocol’s statistical plan, sample-size justification, interim analyses and any sensitivity analyses are not reported in the registry record. These limits constrain interpretation of both performance and safety information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories. — NCT05953363.
• Registry record last updated 2025-12-19; status last verified 2025-12.
• Results first posted 2025-12-19.
• 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

NCT05953363 is a completed, multicenter, prospective, open-label, single-arm post-market study sponsored by Becton, Dickinson and Company. It evaluated BD NRFit™ spinal needles, spinal introducer needles and syringes used in routine neuraxial procedures. Enrollment was 161. The study began on 2023-07-24 and reached primary completion on 2024-05-28.

The primary endpoint was successful subarachnoid placement, defined by spontaneous cerebrospinal fluid emerging from the needle hub during insertion. The primary outcome result is not reported in the registry record. The registry lists 7 outcome measures and 0 analyses. For the safety population of 153 at risk, it reports 1 serious adverse event, 14 other adverse events and 0 deaths; hypoaesthesia is listed among the leading serious terms at 0.7%.

The single-arm design provides no concurrent comparator. The posted information supports a description of the design and selected safety counts, but not a quantitative or comparative interpretation of primary performance.