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 A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors (NCT05130762), a na na study. The primary outcome is Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05130762 |
| Phase | NA |
| Condition | Catheter Related Complication, Vascular Access Site Management, Disinfecting Cap |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 157 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Becton, Dickinson and Company |
| Results posted | Yes |
2. Clinical Question
Population
The study included a general cohort of patients receiving a vascular access device as standard of care in combination with needle-free connectors. The registry reports enrollment of 157. Eligible connectors were followed for up to 45 days after enrollment, with cap attachments, removals, and reasons for changes documented.
Intervention
The device under evaluation was the BD PureHub™ Disinfecting Cap. The study description says a cap was placed on each eligible needle-free connector. The recorded activity included cap attachments and removals, rather than a comparison of alternative treatment strategies.
Comparator
There was no separate comparator group. The study is described as single group, and the allocation entry is NA. The general cohort therefore does not provide a like-for-like control comparison. The registry record does not report a randomized or masked comparison.
Primary question
The primary objective was to assess attachment success and removal success for the caps on swabbable needle-free connectors in a clinical environment. Attachment success is defined as successful attachments divided by total attachments; removal success is defined as successful removals divided by intended removals. The timeframe was up to 45 days after enrollment. Although the registry lists these performance measures, their numerical results are not reported in the registry record.
3. Trial Design
This was a post-market clinical follow-up study of BD PureHub™ Disinfecting Cap use on needle-free connectors attached to vascular access devices. The registry identifies the study model as single group, with one General Cohort and no separate control arm. Allocation is listed as NA and masking as NONE. The study is marked completed, with enrollment of 157. Its recorded start date is 2022-01-31 and its primary completion date is 2023-05-22.
In the cohort description, patients received vascular access devices as standard of care in combination with needle-free connectors. A cap was placed on each eligible connector. Cap attachments and removals, including the reason for a change, were to be documented up to 45 days after enrollment. This design can describe use and performance measures observed during the documented period, but it does not create an untreated or alternative-device group for comparison.
The registry lists the intervention as BD PureHub™ Disinfecting Cap placements, with attachments and removals. It identifies two outcome measures, and the primary outcome concerns attachment and removal success rates. No numerical primary outcome results are reported in the registry record. The record lists zero analyses, so details of an analysis population, model, or statistical procedure for the performance outcomes are not available.
The phase entry is NA. The registry record does not report a sample-size justification, a protocol-level statistical analysis plan, or details about interim analyses. Those omissions mean that the enrollment count should be read as the reported study enrollment, not as evidence about how the study was designed to achieve a particular level of statistical precision.
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 | General Cohort |
|---|---|
| STARTED | 157 |
| COMPLETED | 156 |
| NOT COMPLETED | 1 |
Analysis population for the primary outcome, as defined in the registry: The primary objective was to assess the rate of select performance measures (attachment success rate \& removal success rate) of the BD PureHub™ Disinfecting Caps on swabbable NFC when used in a clinical environment.
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: Enrolled: All participants who signed the ICF Evaluable : All enrolled participants who had at least 1 BD PureHub™ Disinfecting Cap applied.
| Characteristic | Unit | General Cohort |
|---|---|---|
| Participants analysed | 157 | |
| Age, Categorical: <=18 years | Participants | 8 |
| Age, Categorical: Between 18 and 65 years | Participants | 78 |
| Age, Categorical: >=65 years | Participants | 71 |
| Age, Continuous | years | 57.5 (SD 20.74) |
| Sex: Female, Male: Female | Participants | 77 |
| Sex: Female, Male: Male | Participants | 80 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 154 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: Austria | participants | 30 |
| Region of Enrollment: Belgium | participants | 14 |
| Region of Enrollment: Italy | participants | 48 |
| Region of Enrollment: Spain | participants | 65 |
6. Primary Endpoint
The registry lists the primary outcome as Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector, measured over Up to 45 days post-enrollment date.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of attachment success rate |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint covers two device-use performance measures: successful attachment of the BD PureHub™ Disinfecting Cap to a needle-free connector, and successful removal of the cap when removal was intended. The registry defines the attachment rate as successful attachments divided by total attachments. It defines the removal rate as successful removals divided by total intended removals. The intended-removal denominator is important: it describes success among removals that were meant to occur, rather than all observed cap activity.
These measures are used to describe whether the cap could be attached and removed as intended in the clinical environment. Reporting a numerator alongside its denominator would show how many recorded actions met the success definition and how many actions contributed to the rate. The registry lists the unit as a percentage and specifies a 95% confidence interval as the dispersion measure. However, the observed rates, counts, and confidence intervals are not reported in the registry record, so the precision of either estimate cannot be assessed from this record.
The endpoint timeframe is up to 45 days after enrollment. The registry describes use on swabbable needle-free connectors, but does not report further details about how success was adjudicated or how repeated actions were handled in the analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the study as completed and reports enrollment of 157 in a single General Cohort. It describes a follow-up period of up to 45 days after enrollment, during which cap attachments and removals were to be documented. The primary performance outcomes are attachment success and removal success. Their numerical results are not reported in the registry record. In particular, no observed rate, numerator, denominator, or confidence interval is available for either performance measure.
That absence limits what can be concluded about device-use performance from the posted record. A rate alone would describe the proportion of recorded actions meeting the endpoint definition, while its denominator would show the amount of recorded experience supporting that estimate. A confidence interval would communicate statistical uncertainty around the estimate. Because none of these primary outcome values is reported, the magnitude and precision of the performance measures cannot be characterized. The registry entry for zero analyses also does not supply an analysis method or explain how the performance data were processed.
There is no separate comparator cohort. The allocation entry is NA, and the study model is single group. Consequently, the study design as registered is descriptive rather than a controlled comparison of the cap with another device or practice. The record cannot establish a comparative effect or distinguish a change associated with cap use from other influences on observed use.
The safety information is distinct from the missing performance results. In the General Cohort, 157 were listed as at risk for serious adverse events, and 2 were affected. The record lists 0 other adverse events and 2 deaths. The serious event terms listed are Lung neoplasm malignant at 0.6% and Respiratory insufficiency at 0.6%. These figures should be read as reported safety counts and terms, not as evidence of a causal relationship to the device. The registry record does not report the relationship assessment or the causes of the deaths.
Accordingly, the posted record describes the study population, device-use objective, follow-up timeframe, and some safety counts, but does not provide the primary performance results needed to judge the observed attachment and removal rates. The absence of those values is not evidence that the rates were either high or low; it leaves their results unavailable in the registry record.
9. Statistical Methods Explained
Statistical methods that were used to analyze the primary performance outcomes are not reported in the registry record. The registry names attachment and removal success rates and specifies a 95% confidence interval, but does not give the estimates, confidence limits, analysis population, or details of the calculations. The following concepts explain how such measures are generally interpreted; they are not claims about additional methods used in this study.
What does a success rate describe?
General statistical explanation: a rate is a numerator divided by a denominator. For attachment success, the numerator is the number of successful attachments and the denominator is the total number of attachments. For removal success, the numerator is the number of successful removals and the denominator is the total number of intended removals. The two measures answer related but distinct questions, and their denominators need not be the same. The record does not report either numerator or denominator, so neither rate can be reconstructed.
Denominator definition matters because it defines which actions contribute to the estimate. For removals, the stated denominator is intended removals. It would not be appropriate to assume that this includes every cap removal, or that unrecorded or unintended removals were handled in any particular way. The registry does not describe such data-handling decisions. It also does not report whether each patient contributed one action or multiple actions, or how dependence among multiple observations from the same patient was addressed.
How should a confidence interval be understood?
General statistical explanation: a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the statistical method used. A narrower interval indicates greater precision under those assumptions; a wider interval indicates less precision. The registry specifies a 95% confidence interval for the primary measure, but provides no interval limits or method. Therefore, neither the estimated precision nor whether the interval accounted for the structure of the observations can be assessed from the record.
A confidence interval is not a guarantee that the true value lies within a particular interval, and it does not by itself establish practical importance. Interpretation also depends on the endpoint definition, the number of observations, the method used, and the population to which the estimate is intended to apply. The registry record does not report enough performance data to evaluate these elements in this study.
What does the study design allow?
General statistical explanation: a single-group study can describe outcomes observed among participants who receive the intervention, but it does not directly estimate a difference against a concurrent control group. Here, the registry lists a single group and allocation as NA. It does not report a comparator. A descriptive rate from this design, even if available, would not by itself establish how the rate compares with another device, technique, or usual practice.
The outcome involves attachments and removals documented during follow-up, while enrollment is reported at the participant level. These are different units of observation. General statistical explanation: when a participant can contribute multiple actions, observations from one participant may be related to each other. Statistical procedures sometimes account for such clustering, but the registry record does not describe the number of actions or the analysis approach. No specific handling should be inferred.
What planning information is available?
The registry does not report the study's own sample-size justification. A planning illustration associated with the posted results is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect defined as a stated fraction of the observed effect. It is explicitly a planning illustration computed from the observed effect, not the trial's own design. For time-to-event calculations, the description refers to total events; other calculations are described in participants per arm. Such illustrations are planning quantities, not observed enrollment or observed power.
Those assumptions do not change the registered design: this study is single group and has no reported two-arm comparison. Moreover, the numerical primary performance results are not reported in the registry record, so a reader cannot use this record to examine an observed effect for these endpoints. The planning assumptions should not be mistaken for evidence that the study actually used equal allocation, a two-arm design, or a particular test. The registry also does not report an interim-analysis plan, adjustment for repeated actions, or a detailed statistical analysis plan.
What can be concluded from the available methods record?
The endpoint definitions and confidence-interval level are identifiable, but the analytic details and numerical performance findings are not. There is no basis in the registry record to assess the statistical model, missing-data strategy, treatment of multiple observations, or robustness checks for the primary endpoints. The appropriate interpretation is therefore limited to the stated outcome definitions and study structure. General statistical concepts can explain what rates and intervals would mean, but cannot fill in unreported results or analytic choices.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and identifies attachment and removal success as the primary performance measures. It does not report a multiplicity strategy, such as whether the two measures were treated as co-primary outcomes, whether one was prioritized, or whether any adjustment was made for examining more than one outcome. The record also lists zero analyses and gives no numerical results for the primary performance measures. A statistical analysis plan or interim-analysis procedure is not reported in the registry record.
Missing-data details are also not reported in the registry record. The study description says attachments, removals, and reasons for changes would be documented up to 45 days after enrollment, but it does not describe how incomplete follow-up, missing action records, or missing reasons were handled. It is not possible to tell whether missing information was excluded, treated as unsuccessful, imputed, or handled by another method. No such approach should be assumed.
The analysis population is not reported in the registry record. The enrollment count is 157, but the record does not specify how many participants contributed to each performance analysis or whether the analyses used participant-level or action-level observations. It also does not state how repeated attachments or removals from the same participant, if present, were accounted for. These omissions prevent evaluation of the denominator and analysis population behind the intended rates. They also limit assessment of possible bias from incomplete records or differing observation counts.
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 |
|---|---|---|---|
| General Cohort | 2 | 157 | 1.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| General Cohort | 2 of 157 |
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 |
|---|---|
| General Cohort | 0 of 157 |
Most frequent serious adverse event terms
| Event term | Organ system | General Cohort |
|---|---|---|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 157 |
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | 1 of 157 |
Serious events with the highest arm-level rate: lung neoplasm malignant (0.6%), respiratory insufficiency (0.6%).
The General Cohort safety figures list 157 as at risk for serious adverse events and 2 as affected. The registry also lists 157 at risk for other adverse events and 0 affected, along with 2 deaths. The serious adverse event terms shown are Lung neoplasm malignant and Respiratory insufficiency, each reported as 0.6%. These are registry counts and percentages; they do not provide a comparison with another group.
The record does not report whether the serious events or deaths were considered related to the cap, nor does it report the causes of death. The serious event terms should not be interpreted as establishing that the device caused those conditions. The available safety figures also do not describe event timing, duration, severity beyond the serious classification, or participant-level overlap between event categories. Those details are not reported in the registry record.
Safety counts require their context: the cohort size, the observation period, and the definitions and reporting rules used. The record gives enrollment and a follow-up timeframe for cap-use documentation, but does not clarify whether every safety outcome was monitored for exactly the same period. These limitations make the figures descriptive rather than a basis for causal conclusions.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, single-group post-market study enrolled 157 and set out to document BD PureHub™ Disinfecting Cap attachments and removals on eligible needle-free connectors for up to 45 days after enrollment. It defines attachment and removal success as primary performance measures and specifies a 95% confidence interval. These details clarify what the study intended to measure and the setting in which use was observed.
The record does not report the numerical attachment or removal success rates, their numerators or denominators, or the confidence intervals. As a result, it does not allow readers to determine the observed frequency of successful actions or how precise the estimates were. This is an absence of reported results, not a result showing success or failure.
The study has no separate comparator group, with allocation listed as NA and the model listed as single group. It therefore does not supply a direct comparison against another device or practice. Even if the primary rates were reported, they would describe observed performance in the studied cohort and would not alone establish a comparative effect or explain the cause of an outcome.
The safety record lists 2 affected by serious adverse events, 0 affected by other adverse events, and 2 deaths in the General Cohort. It names Lung neoplasm malignant and Respiratory insufficiency, each at 0.6%. The registry does not report whether events were judged related to the device or the causes of death. The counts should be interpreted as descriptive safety reporting, not as evidence of causation.
In sum, the record supports an account of the study design, intended endpoint definitions, follow-up timeframe, and reported safety counts. It does not support a conclusion about the primary performance rates or their precision, and it does not establish a causal or comparative effect.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between an outcome definition and an outcome result. The registry clearly defines attachment success and removal success and identifies a 95% confidence interval as the intended dispersion measure. Yet it does not report the observed rates or intervals. Without those quantities, the endpoint cannot be evaluated for magnitude or precision, regardless of how clearly it was specified.
The design also illustrates why the unit of analysis matters. Enrollment is reported for 157 people, while the primary measures concern attachments and intended removals. Those actions may not correspond one-to-one with participants, but the number and distribution of actions are not reported. Without denominators and analysis details, it is not possible to assess how much recorded information supports the rates or how repeated actions may have been handled.
A single-group post-market study can describe use in a clinical environment, but it does not create a control comparison. This matters when interpreting any observed rate: descriptive performance is not the same as a difference attributable to the device. The registry identifies no comparator and no random allocation. Its findings, as posted, cannot address comparative performance.
The safety counts add a separate descriptive view, but they do not replace missing primary performance results. Counts and listed event terms can inform what was recorded in the cohort, while attribution, timing, and comparison remain unclear or unreported. Taken together, the record underscores that statistical interpretation depends not only on endpoint definitions but also on complete reporting of results, denominators, uncertainty, analysis populations, and design limitations.
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.
A central limitation of the registry record is that it does not report numerical results for the primary attachment and removal success measures. The rates, numerators, denominators, and 95% confidence intervals are unavailable, so the primary performance objectives cannot be evaluated from the posted results. The record lists two outcome measures and zero analyses, but does not supply further analysis detail.
The study is single group, with allocation listed as NA and masking as NONE. No comparator is reported, so the design cannot estimate a direct difference from an alternative device or practice. The General Cohort description concerns patients receiving vascular access devices as standard of care in combination with needle-free connectors; the record does not provide further detail about participant characteristics or how representative the enrolled cohort was.
The observation period for the device-use documentation was up to 45 days after enrollment. The registry does not report how many participants completed that period, whether action records were complete, or how missing data were handled. It also does not report the number of attachment and removal events, whether participants contributed repeated actions, or how such observations were analyzed.
Other important statistical details are not reported in the registry record, including a sample-size justification, analysis population, protocol-level statistical analysis plan, multiplicity handling, and interim-analysis procedures. The safety information lacks reported event attribution, timing, and causes of death. These omissions limit interpretation of both performance and safety; they should not be replaced with assumptions about procedures or findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors — NCT05130762.
- Registry record last updated 2025-01-27; status last verified 2024-03.
- Results first posted 2025-01-27.
- 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
This completed post-market clinical follow-up study evaluated BD PureHub™ Disinfecting Cap use on needle-free connectors attached to vascular access devices. The registry reports a single General Cohort, enrollment of 157, allocation listed as NA, and masking listed as NONE. Cap attachments and removals, including reasons for changes, were to be documented up to 45 days after enrollment.
The primary measures were attachment success and removal success. The registry defines their denominators as total attachments and total intended removals, respectively, and specifies a 95% confidence interval. Numerical performance results are not reported in the registry record.
For the General Cohort, the record lists 2 affected by serious adverse events, 0 affected by other adverse events, and 2 deaths. The listed serious event terms are Lung neoplasm malignant and Respiratory insufficiency, each at 0.6%. The record does not report event attribution or the causes of death. It provides no comparator group or detailed statistical analysis plan.