Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis (NCT00939471), a na na study. The primary outcome is Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months.

2. Clinical Question

This question is about safety during and after balloon dilation, as captured by the registry’s device-related adverse-event outcome. The record also lists secondary outcomes concerning access to and dilation of the sinus ostia, medication use through 1 year, post-operative interventions, days out of school during 12 months of follow-up, and revision rate. These outcomes indicate that the study addressed more than the primary safety count, but detailed results for them are not included in the registry information summarized in the record.

The study’s stated purpose was to assess safety and efficacy in pediatric patients with longstanding sinusitis following failed medical management. Its single-group design can describe events observed among participants who received the device, but it does not provide a randomized comparison for estimating how outcomes would differ under another approach. That distinction is central when interpreting both the primary safety count and the broader stated aims.

3. Trial Design

The registry record describes a non-randomized, multi-center, prospective, clinical study. It lists a single-group model and no masking. The intervention is the Relieva™ Balloon Sinuplasty™ System, with the arm description specifying balloon dilation of the sinus ostium. Allocation is listed as NA, consistent with the record not describing a randomized allocation process. There is no like-for-like control arm listed.

The record gives enrollment as 44 and identifies chronic sinusitis as the condition. The brief summary characterizes the participants as pediatric patients with longstanding sinusitis following failed medical management. More detailed eligibility criteria, the number of centers, participant characteristics, and the number included in each outcome analysis are not reported in the registry record. Enrollment should therefore not be treated as proof that every enrolled participant contributed data to every outcome.

The study status is completed. Its listed start date is 2007-04-01, and its primary completion date is 2009-07-01. The phase is listed as NA. The record identifies Integra LifeSciences Corporation as the sponsor. These registry entries describe the study’s administrative and design context; they do not establish how outcomes were analyzed or whether all planned follow-up was completed for each participant.

The primary endpoint concerns device-related adverse events from the procedure through 12 months after the procedure. The registry also lists secondary outcomes related to device success, effectiveness, post-operative interventions, time out of school, and revision. Although 8 outcome measures are recorded, the number of analyses listed is 0. The analysis methods, analysis populations, and outcome-specific denominators are not reported in the registry record. In particular, there is no reported statistical plan that would explain how the secondary outcomes were summarized or how missing follow-up was handled.

Because the study has one group and no stated randomization, observed outcomes are descriptive of participants in that group. The design does not isolate the effect of the device from other influences by comparing participants assigned to different groups. The record’s stated study purpose and its listed outcomes provide useful context, but they do not substitute for a reported comparative analysis.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months, measured over 12 months.

The primary endpoint is the number of device-related adverse events occurring from the time of the procedure through 12 months after the procedure. The unit is number of events, and the endpoint is classified as a count. It is intended to capture safety events associated with the device over the stated follow-up period.

A count is useful for describing how many qualifying events were recorded, but it is not automatically the same as the number of participants who experienced an event. One participant could, in principle, contribute more than one event; whether that happened and how events were counted are not reported in the registry record. The posted figures list 0 serious adverse events and 0 other adverse events for the Balloon Device group, with 44 at risk in each category. Those values describe the registry’s event counts and listed denominators; they do not supply a confidence interval or a detailed event-level account.

For a safety endpoint, the time window matters because events may be counted during the procedure and over later follow-up. Here, the stated window runs from the procedure through 12 months. The record does not report additional detail about event definitions, severity grading rules, attribution procedures, or whether ascertainment was uniform across all participants. These details would help readers understand precisely which events qualify and how the count was assembled.

The endpoint is relevant to the stated safety aim, but it does not by itself establish the overall safety profile of a device. Interpretation also depends on the size and characteristics of the observed population, duration and completeness of follow-up, event definitions, and the uncertainty around a count of zero. Those supporting details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count, so its natural summary is the number of qualifying events observed during the stated period. Count outcomes differ from continuous measurements, such as a score, and from binary outcomes, such as whether each participant experienced at least one event. An event count can include multiple events for one participant, while a participant count ordinarily records each person once. The registry identifies the primary unit as number of events. It does not report whether event counts were also converted into the number or proportion of participants affected.

What does a zero count tell us?

A zero observed count is a direct description of what was recorded, not a complete estimate of all possible event risk. In general, an estimate based on observed data has uncertainty because another sample of participants could yield a different count. A confidence interval is a range calculated using a statistical method to express uncertainty around an estimate. It is not a guarantee that the true value lies in that range. No confidence interval is reported for the primary outcome in the registry record, so the uncertainty around the posted zero cannot be quantified from the record.

For event data, interpretation also depends on how much observation time participants contributed and whether follow-up was complete. A count alone does not distinguish a group followed consistently for the full stated period from one with incomplete follow-up. The registry gives a follow-up window of 12 months, but does not report the number completing that period, person-time, or the method used to handle missing observations. The 44 listed at risk for each adverse-event category are useful denominator information, but do not establish complete follow-up for every participant.

Why does the study design matter?

A single-group study describes outcomes within one group. It can report the number of events observed after the procedure, but lacks a concurrent comparison group. Random allocation, when used, is intended to make groups comparable on average with respect to both measured and unmeasured factors. This study is described as non-randomized, and no comparator is listed. A difference from an external expectation or from an unobserved alternative cannot be attributed to the device using these data alone.

Masking is listed as none. In general, masking means keeping participants, clinicians, assessors, or analysts unaware of assigned treatment when that is feasible. The record does not specify which roles, if any, were unmasked beyond the entry of none. For a safety endpoint, awareness may matter to how events are noticed, reported, classified, or attributed. The record does not report procedures that would allow those possibilities to be assessed.

What can a confidence interval add?

In general, an interval estimate can communicate the range of values reasonably compatible with the observed data under a stated statistical model. Its width depends on factors such as the amount of information and the variability of the outcome. For counts, methods may need to account for the fact that counts are nonnegative and can be more variable than a simple model assumes. Over-dispersion is the general condition in which count variation exceeds what a chosen model expects; ignoring it can make uncertainty appear too small. There is no reported model, interval, or over-dispersion assessment for this endpoint in the registry record, so no such analysis should be inferred.

With no reported comparison, there is also no basis for interpreting a p-value as evidence of a treatment difference. A p-value, in general, measures how compatible data are with a specified null model under its assumptions; it is not the probability that a treatment works or that the null hypothesis is true. No primary analysis or p-value is listed in the registry record. The absence of a reported analysis is not itself evidence for or against an effect.

How should planning illustrations be read?

Sample-size calculations are design tools, not results from participants. The planning assumptions associated with the record describe an illustration based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They do not establish that the study was designed with those assumptions. The actual trial is recorded as a single-group study, and its own sample-size justification is not reported in the registry record.

A planning illustration estimates how many participants might be needed under chosen assumptions; it is not observed power and does not show that an effect was detected. Its interpretation depends on the assumed effect, variability, analysis, and design. The registry record does not state the trial’s sample-size justification, and the planning assumptions should not be mistaken for a protocol analysis or for a randomized comparison conducted in this study.

More broadly, analysis methods should be selected in advance and matched to the outcome, design, and follow-up structure. The registry does not report the statistical analysis plan, the method for dealing with repeated events, adjustment for other variables, uncertainty estimates, or the rules for including participants in analyses. Without those details, the posted values can be described, but their full statistical analysis cannot be reconstructed from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 8 outcome measures, including the primary safety outcome and secondary outcomes addressing device success, medication through 1 year, post-operative interventions, days out of school during 12 months of follow-up, and revision rate. It lists 0 analyses. The record therefore does not report how these outcomes were analyzed, which outcomes had formal hypotheses, or whether any multiplicity procedure was planned or used.

Multiplicity is a general concern when several outcomes or statistical tests are considered. The more opportunities there are to identify an apparently unusual result, the more important it is to distinguish prespecified primary questions from secondary or exploratory analyses. Methods for controlling multiplicity may adjust the interpretation or threshold for evidence. No such method is reported in the registry record, so it is not possible to determine how multiple outcome questions were handled. The list of outcomes alone does not show that each was analyzed or that a statistically significant result was found.

Missing-data handling is also not reported. In general, incomplete follow-up can affect an estimate if the availability of observations is related to participants’ outcomes or characteristics. Different approaches make different assumptions; simply using the available observations does not necessarily remove bias. The registry does not state the number of participants with complete follow-up, reasons for missingness, imputation methods, or sensitivity analyses.

The analysis population is not reported in the registry record. It is therefore unclear whether the primary endpoint was evaluated among all enrolled participants, those who underwent the procedure, those with available follow-up, or another defined group. The listed 44 at risk for each adverse-event category should be read as the recorded denominator for those figures, not as a description of the rules used for all analyses. Interim analyses and any stopping rules are not reported in the registry record.

11. Safety Results

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

Other (non-serious) adverse events

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

The adverse-event figures list the Balloon Device group with 44 at risk for serious adverse events and 44 at risk for other adverse events. The corresponding event counts are 0 serious adverse events and 0 other adverse events. These are counts in the registry’s listed categories; they should not be read as a rate or as a count of participants affected unless the registry defines them that way. The deaths value is not reported in the registry record.

The primary endpoint specifies device-related adverse events from the procedure through 12 months after the procedure. The record does not provide further detail about event definitions, attribution, severity assessment, or completeness of follow-up. Accordingly, the figures support the limited statement that no events are recorded in the listed categories for the stated group. They do not show that the underlying risk is zero or that every possible adverse event was captured.

These figures are not a comparison against another group. The study is recorded as single-group and non-randomized, with no concurrent control. No comparative safety estimate or statistical uncertainty interval is reported in the registry record.

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

The primary safety result is a description of the recorded event counts for the Balloon Device group: 0 serious adverse events and 0 other adverse events, with 44 at risk in each category. This tells readers what the registry lists for those categories during the specified study follow-up. It is a limited observation from one study group, not a complete estimate of every possible safety outcome.

The result does not establish that the device has no risk. A study can record zero events while uncertainty remains about how often events might occur in a larger group, a different population, or a different setting. The registry does not report a confidence interval, event-level descriptions, or full information on follow-up completeness. Those omissions limit how precisely the zero counts can be interpreted.

The result also does not establish comparative safety. Because no concurrent control group is listed and the study is non-randomized, there is no within-study estimate of how the observed counts compare with outcomes under another treatment or no procedure. The posted counts cannot isolate the effect of the device from other influences.

Nor do the primary figures answer the study’s stated efficacy aim. The registry names secondary outcomes concerning device success, medication use, post-operative interventions, days out of school, and revision, but the corresponding results are not reported in the record details. The safety count should not be extended to conclusions about those outcomes.

In general, evidence is most informative when the outcome definition, denominator, follow-up completeness, analysis method, and uncertainty are all clear. Here, the record identifies the count and follow-up window, but several of those supporting details are not reported in the registry record. A careful reading therefore keeps the conclusion close to the observed data: no events are listed in the specified adverse-event categories among the stated group at risk.

13. Why This Trial Matters Statistically

This study illustrates the difference between documenting an outcome and estimating a comparative effect. A prospective study can record events over a defined follow-up window, and the registry does specify a primary count of device-related adverse events through 12 months. The posted count is informative as a description of what was recorded, while the single-group design limits conclusions that depend on a comparison.

It also highlights why zero events require careful interpretation. Zero is a valid observed count, but it does not mean uncertainty has disappeared. Without an interval estimate, event definitions, and information about completeness of follow-up, readers cannot assess the precision of the safety description in detail. In safety research, these contextual details are part of interpreting a count, not optional decoration.

The record lists a range of secondary outcome topics in addition to its primary safety question. This makes clear why prespecification and multiplicity matter in clinical research: several outcomes can address different aspects of a study’s aims, and readers need to know which analyses were planned and how they were interpreted. The registry lists 8 outcome measures and 0 analyses, while detailed analysis methods are not reported.

Finally, the record provides an example of the distinction between the study’s stated purpose and the evidence available for interpretation. The brief summary says the study was intended to evaluate safety and efficacy, but the posted primary figures address only adverse-event counts. The record’s design, endpoint, and analysis reporting determine what can be concluded from those figures. Keeping those elements separate helps avoid treating an observed count as a controlled treatment effect or as a complete assessment of all stated aims.

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 main limitation for interpretation is the single-group, non-randomized design. No concurrent comparator is listed, so the record cannot support a randomized treatment contrast or establish how outcomes would have differed under another approach. This is especially important when interpreting the primary safety counts: there is no within-study reference group.

The primary endpoint is defined as a count of device-related adverse events through 12 months, but further details about the event definitions, event attribution, and adjudication are not reported in the registry record. The record also does not clarify whether the adverse-event figures count events, affected participants, or both beyond the stated endpoint unit. The listed denominators do not, by themselves, describe how much follow-up each participant contributed.

Outcome-level follow-up completeness, analysis populations, missing-data methods, confidence intervals, and statistical tests are not reported in the registry record. The number of analyses listed is 0, and no statistical analysis plan is reported. As a result, the precision and robustness of the primary count cannot be evaluated from the posted information. Interim analyses and stopping rules are also not reported in the registry record.

The registry lists several secondary outcomes, but their results are not included in the record details. Their definitions, denominators, and analysis methods are not reported. The record also does not report detailed participant characteristics, eligibility criteria, or the number of centers. These gaps restrict assessment of how broadly the observed data might apply and whether follow-up and outcome ascertainment were consistent across participants.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis — NCT00939471.
• Registry record last updated 2024-07-12; status last verified 2024-07.
• Results first posted 2012-08-17.
• 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

The registry record describes a completed, prospective, multi-center, non-randomized, single-group clinical study of the Relieva™ Balloon Sinuplasty™ System in pediatric patients with longstanding sinusitis following failed medical management. Chronic sinusitis is the listed condition, and enrollment is 44. The study’s primary outcome is the number of device-related adverse events from the procedure through 12 months after the procedure.

The adverse-event figures list 44 at risk, 0 serious adverse events, and 0 other adverse events in the Balloon Device group. The record lists 8 outcome measures and 0 analyses. It does not list a concurrent comparator, and detailed analysis methods, uncertainty estimates, analysis populations, and missing-data handling are not reported in the registry record.

The study’s stated purpose included evaluating safety and efficacy. Its posted primary figures describe the recorded safety counts; they do not provide a controlled comparison or results for the listed secondary outcomes.