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 Singapore Tympanostomy Tube Delivery System Study (NCT01046877), a na na study. The primary outcome is Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01046877 |
| Phase | NA |
| Condition | Otitis Media |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Integra LifeSciences Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled patients indicated for tympanostomy tube insertion for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). The registry record gives an enrollment of 25. It does not report further participant characteristics in the information available for this analysis, so the population cannot be described more specifically.
Intervention
The intervention was the Acclarent Tympanostomy Tube Delivery System (TTDS), a device used to place tympanostomy tubes. The registry record describes the study as evaluating the system's safety and efficacy in patients needing tube placement.
Comparator
There was no comparator group. The study is recorded as a single-group study, with allocation listed as NA and masking as none. It is not a randomized comparison, and the record does not describe a control arm for a like-for-like comparison.
Primary question
The primary question was whether ears treated with TTDS had successful tube delivery to the tympanic membrane without acute intraprocedural adverse events. The primary endpoint is described as the percentage of ears meeting both conditions during the procedure. The result and its 95% confidence interval are not reported in the registry record.
3. Trial Design
The registry record describes a completed, single-group device study, NCT01046877, titled “Singapore Tympanostomy Tube Delivery System Study.” The intervention was the Tympanostomy Tube Delivery System. The sponsor was Integra LifeSciences Corporation, and the condition listed was otitis media. Enrollment was 25. The recorded study start was 2008-12, and primary completion was 2010-08.
The study evaluated TTDS use for tympanostomy tube placement in patients indicated for treatment of chronic otitis media with effusion or recurrent acute otitis media. There was one intervention group, described as receiving tube placement with TTDS. Allocation is listed as NA, masking as none, and the model as single group. The record therefore does not describe a randomized allocation or a concurrent control group. A between-group treatment contrast cannot be estimated from this design.
The study phase is listed as NA. The status is completed. The registry record does not report a protocol rationale for the chosen enrollment, a sample-size justification, or additional design details such as eligibility criteria, recruitment setting, or a detailed follow-up schedule. Those details should not be inferred from the study title or the stated objective.
The primary endpoint concerns procedural success: delivery of a tube to the tympanic membrane in the absence of acute intraprocedural adverse events. Listed secondary outcomes include tube extrusion at 12 months post procedure, patent tubes, and ears with adverse events. The record lists 11 outcome measures, but does not provide numerical results for those outcomes in the information. Its analysis count is recorded as 0.
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 | Tympanic Tube Placement |
|---|---|
| STARTED | 25 |
| Completed on Schedule | 6 |
| Completed Study Late | 1 |
| COMPLETED | 7 |
| NOT COMPLETED | 18 |
Reasons for not completing this period:
| Reason | Tympanic Tube Placement |
|---|---|
| Exited voluntarily before tube extrusion | 7 |
| Exited voluntarily after tube extrusion | 11 |
Analysis population for the primary outcome, as defined in the registry: One subject was missing data on intraprocedural adverse events and is excluded from this analysis.
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.
| Characteristic | Unit | Tympanic Tube Placement |
|---|---|---|
| Participants analysed | 25 | |
| Age, Continuous | years | 5.5 (SD 2.7) |
| Sex: Female, Male: Female | Participants | 12 |
| Sex: Female, Male: Male | Participants | 13 |
| Region of Enrollment: Singapore | participants | 25 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events., measured over Procedural.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of ears |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of ears treated successfully with TTDS in the absence of acute intraprocedural adverse events. The registry definition requires successful delivery of a tube to the tympanic membrane and no acute adverse event during the procedure. It is a procedural endpoint: it addresses whether placement was accomplished under the specified safety condition, rather than a later measure of tube function or clinical course.
A percentage can communicate how often a defined event occurred within the group assessed. Combining successful delivery with absence of an acute intraprocedural adverse event makes the endpoint a joint procedural criterion: an ear must meet both components to count as a success. This can be useful when the question concerns completion of the intended procedure alongside immediate procedural safety. It does not, by itself, describe longer-term outcomes.
The registry record identifies the endpoint unit as percentage of ears and lists a 95% confidence interval as its dispersion measure. However, the primary endpoint result and confidence interval are not reported in the registry record. One subject was missing data on intraprocedural adverse events and is excluded from this analysis. The record does not provide the endpoint numerator, the analyzed denominator, or further details about handling missing data.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinically specific procedural outcome, but does not report the numerical primary endpoint estimate. It also does not report the bounds of the stated 95% confidence interval. Consequently, the posted information does not establish how often ears met the defined success criterion or how precise that estimate was. No efficacy conclusion can be drawn from the endpoint description alone.
The study's single-group design limits what can be learned about comparative effects. Without a control group, the record cannot provide a randomized contrast between TTDS and another delivery approach or usual care. Even if a procedural success rate were available, a single-group rate would describe outcomes in the treated group; it would not alone show how outcomes would have differed under an alternative. Allocation is listed as NA, and the study is explicitly not a randomized comparison.
The primary endpoint combines successful tube delivery with no acute intraprocedural adverse events. This definition gives the result a clear procedural interpretation, but the record does not report separate primary component results. It therefore does not show whether any potential failure to meet the combined endpoint would reflect unsuccessful delivery, an adverse event, or both. Nor does the endpoint address later tube patency or extrusion.
The registry lists secondary outcomes for tube extrusion at 12 months, patent tubes, and ears with adverse events. Numerical results for these outcomes are not reported in the registry record. Their listing indicates planned outcome topics, not observed findings. The record also lists 11 outcome measures, while the analysis count is 0; it does not explain the analysis status or provide a statistical analysis account for the listed measures.
The safety information includes 0 serious adverse events among 25 at risk and 1 other adverse event among 25 at risk in the Tympanic Tube Placement group. These are descriptive counts. The record does not supply event details for the other adverse event, and deaths are not reported in the registry record. The serious-event count does not substitute for the missing primary endpoint result, which also depends on successful delivery and acute intraprocedural events.
Overall, the posted information permits a limited description of the design, endpoint definition, and recorded safety counts. It does not permit assessment of the primary success estimate, its precision, secondary outcomes, or comparative benefit. The absence of a reported result should not be interpreted as a zero result or as evidence that an outcome did not occur.
9. Statistical Methods Explained
What does the 95% confidence interval represent?
In general, a confidence interval expresses uncertainty around an estimated quantity. For a percentage, it indicates a range of values compatible with the observed data under the interval method used. A narrower interval generally indicates greater precision, while a wider interval indicates more uncertainty. A confidence interval is not a guarantee that the true value lies within the reported bounds, and it does not by itself establish a causal effect.
The primary outcome lists a 95% confidence interval as its dispersion measure. However, neither the primary estimate nor the interval bounds are reported in the registry record. The interval method is also not reported in the registry record. Without the estimate, its denominator, and interval bounds, precision cannot be assessed from the posted information.
Why does the single-group design matter?
In general, a single-group study estimates outcomes among participants receiving the intervention, without a concurrent comparison group. This can describe what happened during treatment, but it does not separate the intervention's contribution from other influences on outcomes. A randomized comparison is designed to support a different question: whether outcomes differ between allocated groups, subject to the study's conduct and analysis.
This record identifies a single-group model, allocation as NA, and no masking. It does not describe a randomized comparison. Thus, the main statistical target is a group outcome proportion rather than a between-group treatment difference. No relative effect, comparative confidence interval, or comparative hypothesis test is reported in the registry record.
How should a procedural percentage be understood?
In general, a percentage is interpretable only alongside a clearly defined event and the group of observations used to calculate it. Here, the event is meeting both parts of the primary definition: successful delivery of a tube to the tympanic membrane and no acute intraprocedural adverse event. The unit is ears. The record notes that one subject was missing intraprocedural adverse-event data and is excluded from the primary analysis, but it does not state the analyzed denominator or provide the number of ears meeting the endpoint.
The endpoint's combined definition is important. An overall percentage would not show the separate frequency of successful delivery and acute adverse events unless those components were also reported. The registry record does not provide separate primary component estimates. It also does not report the procedure for assigning outcomes when more than one ear is relevant to a participant, so no additional assumptions about that structure should be made.
What can the adverse-event counts tell us?
In general, adverse-event counts describe events or affected participants according to the definitions and reporting rules used in a study. A count should be read with its corresponding group and at-risk count. The registry record reports 0 serious adverse events among 25 at risk and 1 other adverse event among 25 at risk in the Tympanic Tube Placement group. These observations are descriptive; they do not establish the frequency of unreported events or determine whether an event was caused by the device.
The record does not list serious-event terms, and it does not report deaths. The single other adverse event is not described in the information. The record does not provide enough detail to assess event type, timing, severity, relatedness, or duration beyond the serious-versus-other categorization.
What do the planning illustrations mean?
In general, sample-size calculations estimate how much information a future study might need under stated assumptions. They are not results from participants and are not observed power. The planning description for this record specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It also distinguishes total event counts for time-to-event calculations from participants per arm for other calculations.
Those are planning assumptions, not features of the completed single-group study's allocation. The registry information available for interpretation does not include the observed primary endpoint estimate needed to understand an illustration based on a fraction of that effect. Nor does it report the trial's own sample-size justification. The planning calculations should therefore not be read as evidence that this study had a particular power or as a post hoc test of its success.
What analysis details remain unknown?
Statistical interpretation depends on more than an outcome label. The record does not report the exact analysis method for the primary endpoint, the interval construction method, how multiple outcome measures were handled, or a detailed analysis population definition. It records 11 outcome measures and 0 analyses. These omissions prevent reconstruction or independent checking of the primary result from the registry information. General statistical principles can clarify what such methods mean, but cannot replace the unreported trial-specific estimates and procedures.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 11 outcome measures, including the primary procedural endpoint and secondary outcomes concerning tube extrusion at 12 months, patent tubes, and ears with adverse events. Several secondary outcome descriptions are repeated in the record. It does not provide numerical results for those measures in the information available for this analysis. The analysis count is recorded as 0.
When a study assesses multiple outcomes, the chance of at least one apparently unusual finding can increase if each outcome is tested separately. In general, a prespecified analysis plan may address which outcomes are primary, how secondary outcomes are interpreted, and whether any adjustment for multiple testing is used. The registry record does not report a multiplicity strategy, an analysis plan, or a testing hierarchy beyond identifying the primary endpoint. It is therefore not possible to determine whether or how multiplicity was addressed.
For the primary endpoint, one subject was missing data on intraprocedural adverse events and is excluded from the analysis. The record does not report the missing-data mechanism, any imputation method, or sensitivity analyses. It also does not state the analyzed denominator or describe the analysis population beyond this exclusion. No number of analyzed ears or participants should be inferred from the enrollment and exclusion note.
These limits matter because outcome estimates can depend on who is included, how missing observations are treated, and how multiple outcomes are interpreted. The posted information does not permit evaluation of those choices beyond the stated exclusion.
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 |
|---|---|---|---|
| Tympanic Tube Placement | 0 | 25 | 0.0% |
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 |
|---|---|
| Tympanic Tube Placement | 1 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Tympanic Tube Placement |
|---|---|---|
| occluded tube/blood in ear | Ear and labyrinth disorders | 1 of 25 |
| influenza | Infections and infestations | 1 of 25 |
For the Tympanic Tube Placement group, the registry record reports 0 serious adverse events among 25 at risk and 1 other adverse event among 25 at risk. These are separate categories in the record. The other adverse event is not described in the information, so its type, timing, severity, and relationship to the device cannot be assessed.
No top serious-event terms are listed. Deaths are not reported in the registry record. The absence of listed serious-event terms does not provide additional event detail beyond the recorded serious-event count. The counts are descriptive and should be read within the record's reporting scope; they do not establish that unrecorded events were absent or that an event was caused by, or unrelated to, TTDS.
The safety counts are not the primary endpoint result. That endpoint also requires successful tube delivery and absence of acute intraprocedural adverse events, and its estimate and confidence interval are not reported in the registry record. The serious and other adverse-event counts cannot be used to reconstruct that combined procedural percentage.
12. What the Result Does, and Does Not, Mean
The record establishes that NCT01046877 was a completed, single-group study of TTDS for tympanostomy tube placement in patients indicated for treatment of chronic OME or recurrent AOM. It defines procedural success as delivery of a tube to the tympanic membrane without acute intraprocedural adverse events. It also reports the group-level safety counts of 0 serious adverse events and 1 other adverse event among 25 at risk.
The record does not report the primary endpoint estimate or its 95% confidence interval. It also does not give numerical secondary outcome results in the information available for this analysis. Therefore, the posted results do not establish the observed rate of procedural success, its precision, tube patency, or tube extrusion. A missing result is not equivalent to a zero event rate or a null effect.
The single-group design does not provide a randomized comparator. An outcome rate in the treated group, even if available, would not by itself establish how outcomes compare with another device, procedure, or usual care. The design and reporting do not support a causal comparative conclusion.
These findings also do not answer every question about safety. The registry lists 0 serious adverse events and 1 other adverse event, but the other event is not characterized, deaths are not reported, and the record does not provide event-level context. The available information should be interpreted as a limited account of recorded outcomes, not as a complete assessment of all possible risks or later clinical outcomes.
13. Why This Trial Matters Statistically
This study illustrates why a clearly worded endpoint and a reported estimate are both necessary for statistical interpretation. The primary endpoint has a specific procedural definition: successful tube delivery to the tympanic membrane without an acute intraprocedural adverse event. That definition identifies what counts as success, but without its observed percentage and confidence interval, readers cannot assess the result or its precision.
It also demonstrates the distinction between describing outcomes and comparing interventions. A single-group design can document outcomes following use of a device, but does not offer a concurrent randomized reference group. This matters because a treatment group's observed outcome alone cannot isolate the device's contribution from other influences. The registry record explicitly lists no randomized comparison.
The missing primary result highlights the role of complete outcome reporting. The record contains an endpoint definition, a stated confidence-interval measure, and one exclusion for missing intraprocedural adverse-event data, yet does not report the estimate, interval bounds, or analyzed denominator. Without these items, readers cannot assess uncertainty or independently understand how the endpoint was summarized.
Finally, the record lists multiple outcome measures but does not describe multiplicity handling or report their numerical results in the information. The study is therefore a useful example of how design, endpoint definition, missing-data reporting, and result availability jointly determine what conclusions a registry entry can support.
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 for interpretation is that the registry record does not report the primary endpoint result or its 95% confidence interval. It also does not report the denominator used for that endpoint, and one subject with missing intraprocedural adverse-event data is excluded. The resulting estimate and its precision cannot be assessed from the posted information.
The single-group design has no comparator, and the record lists allocation as NA and masking as none. This prevents a randomized between-group assessment. The record also does not report detailed eligibility criteria, participant characteristics, recruitment setting, or a full account of follow-up. These omissions limit the ability to judge how broadly the study population and results might apply.
Although secondary outcomes are listed, including tube extrusion at 12 months, tube patency, and ears with adverse events, numerical results are not reported in the information available for this analysis. The record does not describe outcome-specific analysis methods, multiplicity handling, or missing-data procedures beyond the stated primary endpoint exclusion. It records 11 outcome measures and 0 analyses, without explaining that analysis status.
Safety reporting is also limited: the record reports 0 serious adverse events and 1 other adverse event among 25 at risk, but does not characterize the other event. Deaths are not reported in the registry record. These limitations do not show that additional events or outcomes occurred; they mark what cannot be determined from the registry information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Singapore Tympanostomy Tube Delivery System Study — NCT01046877.
- Registry record last updated 2024-08-06; status last verified 2024-07.
- Results first posted 2014-11-18.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT01046877 is a completed, single-group study of the Acclarent Tympanostomy Tube Delivery System for tympanostomy tube placement in patients indicated for treatment of chronic OME or recurrent AOM. The registry record lists enrollment of 25, a study start of 2008-12, and primary completion in 2010-08. The sponsor is Integra LifeSciences Corporation.
The primary endpoint is the percentage of ears with successful tube delivery to the tympanic membrane and no acute intraprocedural adverse events. One subject with missing intraprocedural adverse-event data is excluded from that analysis. The primary estimate and confidence interval are not reported in the registry record. Safety counts are 0 serious adverse events and 1 other adverse event among 25 at risk. The study has no randomized comparator, and the available record does not provide numerical secondary outcome results.