Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion (NCT02150044), a na na study. The primary outcome is Ear Outcome Success.

2. Clinical Question

3. Trial Design

This was a prospective, multicenter, single-group clinical study of the Acclarent Tympanostomy Tube Delivery System. The registry describes the study as non-significant risk (NSR) and states that it aimed to evaluate safety and performance. It records enrollment of 29 and a completed status. The listed condition is otitis media.

The record gives a start date of 2010-02 and a primary completion date of 2010-10. The sponsor is Integra LifeSciences Corporation. The phase is recorded as NA. Allocation is also recorded as NA, and masking as none. These entries fit the registry’s single-group design description; they do not indicate a randomized comparison or blinded assessment.

The primary outcome is Ear Outcome Success, measured in ears at the procedure visit on Day 0. Its definition concerns successful delivery of the tympanostomy tube across the tympanic membrane. The outcome description says it was evaluated for the 13 study cohort subjects only, not the 16 lead-in subjects. The record also lists Procedure Success and Tube Retention as secondary outcomes. It does not provide results for those outcomes in the registry record for this analysis.

Enrollment and the primary endpoint population are not interchangeable descriptions: the record states that 29 were enrolled, while the primary endpoint description identifies a study cohort and excludes lead-in subjects from that assessment. The registry does not explain the relationship between those groups beyond that distinction. It also does not provide a detailed protocol, a statistical analysis plan, or an account of how participants were selected for each group. Thus, the design can be described, but key operational details and the primary outcome result 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: Each investigator was required to treat a minimum of two (2) subjects as lead-in procedures prior to enrolling subjects to the test cohort. Subjects enrolled to the lead-in cohorts were required to meet the same eligibility criteria and complete the same protocol-required procedures as the study cohort.

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.

Population: Baseline Analysis Population includes 16 lead-in subjects and 13 study cohort subjects

6. Primary Endpoint

The registry lists the primary outcome as Ear Outcome Success, measured over Day 0 (at procedure visit).

The primary endpoint, Ear Outcome Success, measures whether the tympanostomy tube was successfully delivered across the tympanic membrane. It is defined per ear and assessed at the procedure visit on Day 0. This is a procedural performance measure: it addresses whether the intended delivery step was completed, rather than measuring longer-term tube retention or a broader clinical outcome.

A per-ear measure is appropriate to the endpoint’s stated focus because successful delivery is defined for each ear. The unit also matters when interpreting the denominator: the record identifies ears as the unit, rather than describing the endpoint as a participant-level outcome. The endpoint description says the assessment covered the 13 study cohort subjects only and excluded the 16 lead-in subjects.

Procedural success can be useful for evaluating whether a delivery system completes its immediate technical task. It does not by itself establish how long a tube remains in place, whether otitis media changes, or whether performance differs from another approach. Tube Retention is separately listed as a secondary outcome, reinforcing that immediate delivery success and subsequent retention are distinct questions. The registry record does not report the observed count or other result for Ear Outcome Success, so the endpoint’s definition is available but its measured performance cannot be described from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count-type endpoint whose stated unit is ears. The underlying event is successful delivery of the tympanostomy tube across the tympanic membrane. For a count outcome, a useful report ordinarily states how many units met the success definition and the number assessed. Those quantities allow readers to understand the observed frequency and its denominator. The registry describes the endpoint but does not report those outcome values, so an observed rate cannot be reconstructed from the available record.

General statistical explanation: a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the method used. It does not guarantee that the true value lies within the interval, and it does not replace the point estimate or the definition of the analyzed population. For a proportion, interpretation depends on the event count, denominator, and method. Since the registry record does not report the primary outcome count, denominator, or interval, its precision cannot be assessed. No interval should be inferred from the enrollment figure alone.

The endpoint is assessed per ear, while the registry describes study subjects as people. General statistical explanation: when more than one measured unit can come from the same person, measurements may be related rather than statistically independent. Analyses may need to account for such clustering if it is present. The record does not state how many ears were assessed or whether multiple ears from a subject contributed, so the dependence structure and any adjustment cannot be determined. This is a consideration for interpreting per-ear results, not evidence that a particular analysis was used.

The design is single-group. General statistical explanation: a single-group outcome can describe what happened in the observed group, but a comparison with a separate group is needed to estimate a between-group contrast. Without a comparator, differences from an external benchmark may reflect differences in patients, procedures, follow-up, or measurement as well as the device. The registry identifies no randomized control group and no masking. It does not report an adjusted comparative analysis.

The registry records 0 analyses. That entry does not provide a statistical model, estimation method, confidence-interval method, or test for the primary endpoint. None of these methods should be assumed. In particular, the record does not state whether the endpoint was analyzed as a proportion, whether any adjustment was planned, or how incomplete observations would be handled.

The registry also describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. For time-to-event planning, the illustration uses the total number of events under the Schoenfeld approach; other planning rows are expressed as participants per arm. These assumptions describe planning calculations, not the conduct of this single-group trial. They do not establish that the trial was designed with two arms, and they are not observed power. The record does not report the trial’s own sample-size justification or a protocol-based power analysis. Any planning figures should therefore be read as hypothetical illustrations, not as evidence about the study’s actual design or ability to detect an effect.

General statistical explanation: over-dispersion occurs when count variability is greater than expected under a model’s assumptions. It can make standard errors too small if not addressed, reducing the reliability of uncertainty estimates. Whether over-dispersion is relevant depends on the outcome and the chosen model. The registry record does not identify a count model or provide outcome data from which this feature could be evaluated, so no claim about over-dispersion or its handling is warranted.

For the safety outcomes, the registry gives the number at risk and number affected for serious and other adverse events. These are descriptive counts. A formal comparison or modeled risk estimate would require an appropriate comparison and additional analytic detail. The record does not list such analyses. The raw figures should therefore be kept distinct from comparative claims, and the missing primary performance result should not be filled in by calculations from unrelated enrollment or safety information.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome, Ear Outcome Success, and two secondary outcomes, Procedure Success and Tube Retention. It reports three outcome measures in total. Listing outcomes does not establish how statistical testing was organized or whether any adjustment for multiple testing was planned. No multiplicity procedure is reported in the registry record, and the record lists 0 analyses. The endpoint labels alone do not reveal whether outcomes were tested, estimated descriptively, or handled in a prespecified hierarchy.

When several outcomes are examined, the chance of at least one apparently unusual result can increase if each is tested separately without an appropriate plan. General statistical explanation: multiplicity methods can manage that issue, but the right approach depends on the scientific questions and analysis plan. It would be inappropriate to assume a correction or infer that one was unnecessary. The registry does not report a statistical plan that would resolve this question.

Missing-data handling is also not reported in the registry record. The endpoint description specifies that the primary assessment covered the 13 study cohort subjects and excluded the 16 lead-in subjects, but it does not state whether all eligible ears had an assessable result, how missing observations were defined, or how any were treated analytically. The absence of a reported outcome value means that completeness cannot be checked from the record.

The record does not define an intention-to-treat, per-protocol, or other analysis population. The distinction between enrolled subjects and the stated primary endpoint cohort is given, but the reason for that distinction and the analysis rules are not. These omissions limit reproducibility: readers cannot determine which observations were included, whether exclusions occurred, or how the secondary outcomes relate to the primary population.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports 0 serious adverse events among 29 at risk in the Tympanostomy Tube group. It reports 5 affected by other adverse events among 29 at risk. These are separate registry categories; the figure for other adverse events should not be added to the serious-event figure or interpreted as a count of individual event episodes. The record does not list serious adverse-event terms, and deaths are not reported in the registry record.

These figures describe what the registry records for the stated group and risk denominator. They do not provide a comparison with another treatment or establish whether any event was caused by the device. The registry does not provide further details about event definitions, severity within the other-adverse-event category, timing, follow-up, or how events were collected. A zero recorded serious-event count does not prove that risk is absent; it describes the reported observation in this study.

General statistical explanation: adverse-event counts are informative but their interpretation depends on follow-up, ascertainment, definitions, and the population observed. Without those details and a comparator, the counts should be read descriptively rather than as comparative safety evidence. They do not supply the missing primary delivery-success result.

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

The registry record establishes the study’s basic question and design. It describes a prospective, multicenter, single-group evaluation of the Acclarent Tympanostomy Tube Delivery System for patients requiring tympanostomy tube insertion for otitis media. Its primary endpoint is successful delivery across the tympanic membrane per ear at the procedure visit on Day 0. It also identifies Procedure Success and Tube Retention as secondary outcomes.

What the record does not provide is the observed primary endpoint result. The endpoint description specifies the study cohort and excludes lead-in subjects, but the record does not report the number of ears with successful delivery, the number assessed, or an estimate of uncertainty. The posted record therefore cannot answer how often delivery success occurred or how precisely it was estimated. The secondary outcome results are likewise not reported in the registry record for this analysis.

The study’s single-group design also limits what any outcome could establish. Without a control group, there is no direct randomized estimate of performance relative to another device or approach. An observed outcome, if reported, would describe the experience in the study group and should not be treated as proof of superiority or a causal difference.

The safety entries report 0 serious adverse events and 5 affected by other adverse events, with 29 at risk in each registry category. These are descriptive figures. They do not demonstrate absence of risk or provide a comparative safety assessment. Deaths are not reported in the registry record.

Thus, the record communicates a study purpose, design, endpoint definition, and limited adverse-event counts. It does not report enough primary outcome information to make a statistical assessment of device performance. Missing result data should not be replaced by assumptions based on the study title, enrollment, or endpoint definition.

13. Why This Trial Matters Statistically

This study illustrates why an endpoint definition and an endpoint result are different kinds of evidence. The registry gives a concrete definition of immediate procedural success: delivery of the tympanostomy tube across the tympanic membrane, assessed per ear at the procedure visit on Day 0. That definition tells readers what the study intended to measure, but it does not tell them what was observed. Without the event count and denominator, the performance estimate and its precision cannot be evaluated.

The distinction between subjects and ears is also statistically important. The registry reports enrollment of 29, while the primary endpoint description refers to the 13 study cohort subjects and excludes the 16 lead-in subjects. Since the outcome unit is ears, enrollment cannot be substituted for the endpoint denominator. Clear reporting of the assessed units and their relationship to participants is necessary for interpreting a per-ear result.

The single-group design highlights the boundary between descriptive evidence and comparative evidence. A result in a treated group can characterize observed experience, but it cannot by itself estimate a contrast against another approach. A reader should not infer comparative efficacy or safety from the study’s stated aim or from the fact that the registry records a completed study.

Finally, the absence of a reported analysis plan and the registry’s entry of 0 analyses limit the ability to assess how uncertainty, missing observations, or multiple outcomes were handled. These are not merely technical details: they determine how reproducible and interpretable reported estimates would be. In this record, the primary result itself is absent, making those analytic questions especially consequential.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most important limitation of the registry record is that it defines the primary endpoint but does not report its observed result. The count of successful deliveries, the number of ears assessed, and an uncertainty estimate are not reported in the registry record. Therefore, the primary performance outcome cannot be quantified or assessed for precision.

The endpoint was evaluated for the 13 study cohort subjects only, not the 16 lead-in subjects, but the record does not explain the selection of these groups or provide the number of ears assessed. Enrollment of 29 does not resolve the endpoint denominator. The record also does not describe missing endpoint observations or how they were handled.

The single-group design provides no randomized comparator, and masking is recorded as none. The registry does not report an analysis plan or analysis results. It therefore does not establish what statistical methods were applied, whether outcomes were adjusted for multiplicity, or how the secondary outcomes were defined and analyzed in practice.

Safety reporting is limited to registry counts: 0 serious adverse events and 5 affected by other adverse events among 29 at risk. The record does not provide further event details or report deaths. These counts should not be interpreted as comparative evidence or as proof that no risk occurred. The planning illustration is not the trial’s own sample-size justification and does not represent observed power. Overall, the record leaves substantial gaps between study registration, outcome measurement, and interpretable results.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion — NCT02150044.
• Registry record last updated 2024-07-12; status last verified 2024-07.
• Results first posted 2014-09-25.
• 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

NCT02150044 is a completed, prospective, multicenter, single-group study sponsored by Integra LifeSciences Corporation. The registry describes it as a non-significant risk (NSR) study evaluating safety and performance of the Acclarent Tympanostomy Tube Delivery System for patients requiring tympanostomy tube insertion for otitis media. Enrollment was 29; the start date was 2010-02 and primary completion was 2010-10. Phase and allocation are recorded as NA, and masking as none.

The primary endpoint is Ear Outcome Success, defined as successful delivery of the tympanostomy tube across the tympanic membrane per ear at the procedure visit on Day 0. It was evaluated for the 13 study cohort subjects only, not the 16 lead-in subjects. Procedure Success and Tube Retention are listed as secondary outcomes. The primary and secondary outcome results are not reported in the registry record. Safety entries report 0 serious adverse events and 5 affected by other adverse events among 29 at risk. Deaths are not reported in the registry record.