Hummingbird TTS Ear Tube Delivery Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Hummingbird TTS Ear Tube Delivery Study (NCT02165384), a na na study. The primary outcome is Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane.

2. Clinical Question

3. Trial Design

This was a completed, single-group device study of ear tube placement with the Hummingbird TTS. The registry reports enrollment of 199 and lists otitis media as the condition. The recorded start was 2014-01, and primary completion was 2018-03-01. The sponsor was Preceptis Medical, Inc. The study phase is listed as not applicable.

Allocation is listed as not applicable, masking as none, and the model as single group. These features mean the record does not describe random assignment or a masked comparison. The intervention is ear tube placement with the Hummingbird TTS. No alternative intervention or control arm is reported, so the study is not a like-for-like comparison of treatments or devices.

The registry describes the primary outcome at the ear level, while enrollment and the safety counts are reported at the patient level. It states that 393 ears in 199 patients received placement from the device. This distinction matters when interpreting the endpoint: ears from the same patient may not represent statistically independent observations. The record does not describe how any such within-patient relationship was handled in an analysis.

The registry lists two outcome measures and zero analyses. It does not report an analysis plan, a sample-size justification for the trial, or inferential results for the primary endpoint. The description says data may be presented after enrollment and analysis of pre-operative and procedure data; it does not establish which analyses were ultimately performed. The study's completion status alone does not supply those missing result details.

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

Analysis population for the primary outcome, as defined in the registry: 393 ears in 199 patients received ear tube placement from the Hummingbird device.

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: Patients scheduled for tympanostomy tube insertion that are at least 6 months old

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane, measured over intra operative.

The primary endpoint is the percentage of ears in which an ear tube was successfully delivered across the tympanic membrane. The registry defines success by whether the TTS was used during the procedure to make an incision in the tympanic membrane and deploy an ear tube. The timeframe is intra operative, making this a measure of technical completion during the procedure rather than a later follow-up outcome.

This endpoint is relevant to the device's immediate procedural purpose: it records whether the intended delivery steps were completed for an ear. An ear-level measure can describe the frequency of procedural success, but it is not by itself a measure of longer-term outcomes, patient experience, or comparative effectiveness. Those questions require relevant measures and results, which are not reported in the registry record.

The registry identifies 393 ears in 199 patients as the population that received placement. It does not report the number of ears meeting the success definition or a percentage for the primary endpoint. Nor does it report a confidence interval or other uncertainty estimate. The endpoint's definition is therefore available, but its observed result and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The methods information in the registry record is limited. It identifies a single-group study and defines an ear-level primary endpoint, but does not report an analysis plan or primary endpoint analysis. The statistical concepts below explain what would ordinarily be relevant to interpreting this kind of outcome; they do not establish which methods were used in this study.

What kind of endpoint is this?

The primary outcome is a count-based procedural measure expressed as a percentage of ears meeting a binary definition: the tube was delivered using the TTS as specified, or it was not. In general, a percentage summarizes the proportion of eligible observations with the event of interest. To interpret an observed percentage, readers need both the event count and the denominator used in the analysis. The registry identifies 393 ears in 199 patients as having received placement, but does not report a success count or a reported endpoint percentage.

A confidence interval would express the statistical uncertainty around an estimated percentage. It is not a guarantee about the range of future results; rather, it indicates how compatible the observed data are with a range of underlying values under the method's assumptions. No confidence interval for the primary outcome is reported, so its precision cannot be assessed from the registry record.

Why does the unit of analysis matter?

The endpoint is measured per ear, while the reported enrollment and safety group are per patient. General statistical practice requires attention to whether observations are independent. If one patient contributes more than one ear, outcomes within that patient may be correlated because they share patient-level features and procedural circumstances. An analysis that treats correlated ears as fully independent can produce uncertainty estimates that are too narrow. Methods such as patient-level aggregation or models that account for clustering may be relevant in general, but the registry record does not say whether either approach was used. It also does not report an analysis population or clarify how the outcome denominator was selected.

What does the design allow?

A single-group study can describe outcomes within the group receiving the device. It does not provide a concurrent control group for estimating a between-group treatment effect. The registry lists allocation as not applicable and masking as none; it does not report randomization or a masked comparison. Consequently, no comparative effect estimate, adjusted or otherwise, is reported. A statistical test against a comparator or a causal interpretation should not be inferred from the endpoint description.

The registry lists zero analyses. It does not report a statistical plan, a hypothesis test, a p-value, a model, or an adjustment strategy. The primary endpoint description alone cannot establish whether the investigators planned an interval estimate, a test against a threshold, or a descriptive summary. Those details are not reported in the registry record.

How should planning illustrations be read?

Planning illustrations based on an observed effect are different from the study's original design and from an observed-power calculation. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. The illustrations are planning scenarios, not evidence that the study had a particular power after it was completed. The registry record does not report the numerical illustration results in the registry record for interpretation here, and its actual study design is single group rather than equal allocation between two arms. The illustration assumptions therefore do not describe the trial's allocation or a trial-specific comparison.

More generally, power calculations depend on assumptions about the effect to detect, variability, design, and analysis. When those inputs differ from what occurs in a study, a planning estimate may not describe the study's eventual precision. A retrospective calculation based on an observed effect should not be presented as observed power. No trial-specific sample-size justification or planning assumptions are reported in the registry record.

Why can variation beyond a simple count matter?

For a binary outcome, the precision of a proportion depends on the amount of information in the data and on the analysis assumptions. Dependence among observations, missing outcomes, or differences in how outcomes are ascertained can affect uncertainty. In other settings, over-dispersion means that the observed variability exceeds what a simple statistical model expects; accounting for it can widen uncertainty estimates and avoid overstating precision. These are general considerations, not reported findings about this trial. The registry does not provide enough analysis detail to determine whether such issues arose or how they were handled.

In practical terms, the available registry information permits a description of the endpoint and design, but not a reconstruction of the primary analysis. A reported success count, denominator, method for accounting for patient-level clustering, and an uncertainty estimate would be needed for a fuller statistical interpretation. Those results and methods are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures, but it does not report a multiplicity plan. Multiplicity concerns arise when several outcomes or statistical tests are considered: the chance of at least one apparently notable finding can increase as the number of tests increases. In general, a prespecified hierarchy or an adjustment method can clarify how multiple results should be interpreted. The record does not say whether outcomes were prioritized beyond identifying the primary endpoint, whether any adjustment was planned, or whether additional analyses were conducted.

The record lists zero analyses. It does not report primary endpoint results, a statistical analysis plan, or the methods used to handle missing observations. The endpoint description notes that data may be presented when enrollment has been completed and pre-operative and procedure data analyzed, but it does not report whether any observations were missing, excluded, or unavailable for analysis. The analysis population and the denominator used to calculate the primary outcome are not reported in the registry record.

These omissions limit interpretation in related ways. Without the analysis population, it is not possible to tell whether the outcome was assessed for all ears that received placement or a subset. Without missing-data information, readers cannot judge whether missing outcomes might affect the result. And without a multiplicity strategy, the intended interpretation of several outcome measures cannot be established. These are unreported methods, not evidence that missing data or multiplicity problems necessarily occurred.

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.

The registry lists 199 patients at risk for serious adverse events, with zero serious adverse events recorded. It also lists 199 at risk for other adverse events, with zero other adverse events recorded, and zero deaths. These are the safety counts in the registry record for the Hummingbird TTS group.

A zero count means that no events of that category are listed in the posted record for the stated at-risk group. It does not establish that the underlying risk is zero, nor does it show that an event could not occur in other patients or settings. The record does not provide serious adverse event terms, descriptions of event ascertainment, follow-up details, or an analysis of safety uncertainty. No top serious adverse event terms are listed.

These safety entries are distinct from the primary procedural success endpoint. They do not indicate how often the ear tube was successfully delivered, and they do not establish a comparison of safety with another procedure or device. The single-group design has no reported control group for such a comparison. The counts should therefore be read as descriptive registry entries, not as a comparative safety estimate or a complete account of all possible harms.

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

The registry record gives a clear definition of the primary procedural question: whether the Hummingbird TTS was used to make the tympanic membrane incision and deploy an ear tube. It reports that 393 ears in 199 patients received placement from the device. It also reports zero serious adverse events, zero other adverse events, and zero deaths in the safety group.

What it does not report is the primary endpoint result. There is no success count or percentage, and no confidence interval or other uncertainty estimate. Therefore, the available record cannot quantify the frequency or precision of successful delivery. The design description and endpoint definition should not be mistaken for evidence of a particular outcome.

The study was single group, with no comparator reported. It cannot estimate a relative effect against another device or procedure from the information in the record. Even a reported procedural success percentage would describe observed outcomes in the study group, not by itself demonstrate that the device caused those outcomes or that outcomes would differ under another approach.

The safety counts are also limited in scope. No events are listed in the recorded categories, but the registry does not provide event ascertainment details or an uncertainty analysis. The entries do not prove absence of risk. Similarly, the lack of primary endpoint analyses in the record does not establish that no analysis occurred outside the registry; it means that the analysis results are not reported in the registry record.

The most defensible reading is consequently bounded: the record identifies the device, study design, procedural endpoint, study population, and listed safety counts. It does not establish the observed primary success rate, its precision, a comparative benefit or harm, or the completeness of outcome ascertainment. Those questions require results or methods not reported in the registry record.

13. Why This Trial Matters Statistically

This study illustrates why outcome definitions and outcome results must be distinguished. The registry precisely describes a procedural success criterion, but does not report how many ears met it or the resulting percentage. A well-defined endpoint is essential for reproducible interpretation, yet it does not substitute for an observed estimate and its uncertainty.

The study also highlights the importance of matching the statistical unit to the clinical data structure. The primary outcome is recorded per ear, while enrollment is reported per patient. When multiple observations can come from the same patient, their dependence may affect standard errors and confidence intervals. Reporting how this structure was handled is important for readers assessing precision.

Its single-group design makes the scope of inference another central issue. Descriptive procedural outcomes can be informative, but without a comparison group they do not estimate a relative effect. This distinction helps prevent a procedural count from being interpreted as evidence of comparative effectiveness or causality.

Finally, the registry demonstrates the limits of interpreting safety zeros without detail about follow-up and ascertainment. Zero recorded events are useful descriptive data, but do not quantify uncertainty or rule out uncommon events. Transparent reporting of denominators, event definitions, analysis populations, missing data, and statistical methods would support a fuller assessment. The record's listed design and safety information are informative, while the absent primary result and analysis details materially constrain statistical conclusions.

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 this trial is that the registry record does not report the primary endpoint result. Although the endpoint definition and the population that received placement are described, no success count, percentage, or uncertainty interval is given. The central procedural outcome therefore cannot be quantified from the record.

The study has no reported comparator and is described as single group. This prevents a direct estimate of how outcomes compare with another device or procedure. The record also lists no masking. It does not report details of outcome adjudication, operator experience, procedural setting, or other factors that might affect the observed outcome; their absence from the record should not be taken as proof that they were not considered.

The ear-level outcome and patient-level reporting raise a possible dependence issue. The record does not say whether observations from ears within the same patient were analyzed with a method that accounts for clustering. It also does not state the analysis denominator, the analysis population, or how missing or unevaluable outcomes were handled.

Further limitations are the absence of a reported statistical analysis plan and the listing of zero analyses. Multiplicity handling for the two outcome measures is not described. The safety counts are not accompanied by event definitions, follow-up details, or uncertainty estimates. The record's planning assumptions do not constitute the trial's design, and no trial-specific sample-size justification is reported in the registry record. Together, these omissions leave substantial uncertainty about the methods and results beyond the basic study description.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Hummingbird TTS Ear Tube Delivery Study — NCT02165384.
• Registry record last updated 2019-01-03; status last verified 2018-12.
• Results first posted 2019-01-03.
• 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 describes a completed, single-group study of ear tube placement with the Hummingbird TTS for otitis media. Enrollment is listed as 199, with a start date of 2014-01 and primary completion on 2018-03-01. The primary endpoint is the percentage of ears with successful tube delivery across the tympanic membrane, defined by use of the device to make an incision and deploy the tube. The record reports 393 ears in 199 patients received placement.

The primary endpoint count, percentage, and uncertainty estimate are not reported in the registry record. The record lists zero analyses. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths among the stated at-risk groups. With no comparator and limited analysis detail, the registry supports a description of study design and recorded safety counts, but not a quantified primary result or comparative effect.