A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis (NCT00840970), a randomized na study. The primary outcome is Device Success Rate.

2. Clinical Question

3. Trial Design

This was a randomized, quadruple-masked, parallel-design study. The registry lists an enrollment of 50 and identifies the study as completed. The listed study dates are 2008-03 for the start and 2009-03 for primary completion. The phase is recorded as NA, and the sponsor is Intersect ENT.

The arm descriptions distinguish an efficacy comparison from a bilateral safety/PK group. In the efficacy control arm, a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator. In the efficacy treatment arm, a drug-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the intervention. Both placements followed FESS. A separate Safety/PK arm received drug-coated splints in both ethmoid sinus openings. The registry also lists a Pilot 15 mm arm and two 25 mm arms, labeled Efficacy and Safety/PK.

The arm-level counts recorded with the primary outcome are 7.0 for Pilot 15 mm, 38.0 for Efficacy 25 mm, and 5.0 for Safety/PK 25 mm. These are the posted arm values and counts; the record does not explain how the arm labels map onto every detail of the randomized-side description. In particular, it does not give a separate account of randomization procedures, allocation concealment, or how masking was maintained. Those details are not reported in the registry record.

The design includes more than one treatment context: unilateral placement for the efficacy comparison and bilateral placement for the Safety/PK group. These groups should not be treated as interchangeable arms in a single two-group efficacy contrast. The registry does not report a statistical comparison across all listed groups.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Analysis per patient.

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: Analysis prespecified for Efficacy 25 mm (Pivotal n=25) and all patients only. They cannot be specified per group.

6. Primary Endpoint

The registry lists the primary outcome as Device Success Rate, measured over Baseline.

The primary endpoint is Device Success Rate, defined as a ratio: successful deployments of the Sinexus Intranasal Splint divided by attempted sinuses. A deployment was considered successful if the implant procedure ended with successful splint placement on the intended side. The listed unit is ethmoid sinuses, the timeframe is Baseline, and the analysis population is described as per patient.

This endpoint addresses a procedural question: whether the device can be placed as intended during the implant procedure. It is distinct from outcomes that describe subsequent anatomy or tissue changes. The secondary outcomes named in the registry are Middle Turbinate Lateralization, Middle Meatus Patency, Significant Adhesion Occurrence, and Polypoid Tissue Changes. The registry does not report numerical results for those outcomes in the record summarized for this analysis.

The endpoint description defines a ratio, but the registry’s arm entries give values of 14.0, 76.0, and 10.0 alongside counts of 7.0, 38.0, and 5.0. The record does not clarify the scale or interpretation of these values in relation to the stated ratio, nor does it provide the numbers of successful deployments and attempted sinuses separately. They therefore cannot be read as an independently verified deployment proportion or as a treatment effect. The reported endpoint definition is informative, but the numerical entries do not support a transparent reconstruction of the rate from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, quadruple-masked, parallel design. Randomization is intended, in general, to make treatment groups comparable with respect to both measured and unmeasured characteristics on average. It does not guarantee identical groups in a particular trial, especially when groups are small. Masking is intended, in general, to reduce the influence of treatment knowledge on care, assessment, or reporting. The record does not describe which people were masked or the procedures used to preserve masking.

What does the endpoint represent?

Device Success Rate is defined as a ratio of successful deployments to attempted sinuses. Ratios require both a clearly specified numerator and denominator, and the interpretation depends on what counts as an attempt and what counts as success. The registry defines success as placement on the intended side by the end of the implant procedure. It gives Baseline as the timeframe and identifies ethmoid sinuses as the unit, while also describing the analysis as per patient. The registry record does not explain how the sinus-level endpoint was handled in a patient-level analysis.

The arm-level entries list 14.0, 76.0, and 10.0, with associated counts of 7.0, 38.0, and 5.0. The record does not state how these values correspond to the ratio’s numerator and denominator or explain their scale. Without that clarification, a rate cannot be reconstructed from the entries. No recalculated comparison is available: the record does not provide the component counts needed for a simple unadjusted comparison, and it reports zero analyses.

How should a comparison be interpreted?

For a randomized efficacy comparison, a useful statistical summary would ordinarily state the result for each group and an estimated difference between groups. A confidence interval would describe the range of effects compatible with the observed data under the method used; in general, wider intervals indicate less precision. A p-value, when reported, addresses how compatible the data are with a specified null hypothesis under an analysis model. Neither a p-value nor an interval is reported for a treatment comparison in this registry record.

There are three listed groups, but the arm descriptions do not define one uniform three-group efficacy question. The unilateral coated-versus-non-coated comparison belongs to the efficacy context, while bilateral coated placement is described as Safety/PK. The Pilot 15 mm label is also separate. In general, comparisons should follow the prespecified scientific question and design rather than treating all available groups as interchangeable. The registry record does not provide a detailed analysis plan or state which contrasts were planned.

What do the safety counts show?

The registry reports the number at risk and counts for serious adverse events, other adverse events, and deaths in each group. A count of zero means that no events in that category were recorded for that group in the posted results. It is not, by itself, an estimate of the likelihood of an event beyond the group and reporting period. In general, safety interpretation depends on the number observed, duration of observation, event definitions, and completeness of follow-up. The record does not provide further detail on these points or list serious adverse-event terms.

What do planning calculations mean?

The registry’s planning assumptions describe an 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 assumed effect to detect is described as a stated fraction of the observed effect. For time-to-event outcomes, the stated convention is a total event count; other outcomes use participants per arm. These are planning assumptions, not evidence about the trial’s actual design choices. No numerical planning counts are reported in the registry record summarized for this analysis, and such calculations are not observed power. The registry does not report the trial’s own sample-size justification or explain whether any planning illustration was used when the trial was designed.

In general, a sample-size calculation depends on the outcome, target effect, variability or event rate, chosen error rates, allocation, and analysis method. Changing an assumption can change the required sample size. When the observed effect is used as the starting point, an illustration describes the sample size associated with that assumed effect under the selected method; it does not establish that the trial had a particular probability of detecting an effect. No details about the original protocol’s assumptions or interim analyses are reported in the registry record.

What cannot be assessed from the posted analyses?

Because no analyses are reported, there is no basis to assess model fit, adjustment for baseline characteristics, handling of correlated sinus-level observations within a patient, or precision of an efficacy contrast. In general, observations from multiple sites within one person may be statistically dependent, and methods should account for that dependence when relevant. Whether this issue arose in the analysis and how it was addressed are not reported in the registry record. The same applies to missing-data methods, exclusions, and sensitivity analyses.

10. Multiplicity, Missing Data and Analysis Populations

The registry names four secondary outcomes: Middle Turbinate Lateralization, Middle Meatus Patency, Significant Adhesion Occurrence, and Polypoid Tissue Changes. It also records six outcome measures overall, but the record summarized for this trial provides names for only four secondary outcomes in addition to the primary endpoint. Details for any remaining outcome measure are not reported in the registry record.

Multiplicity arises when several outcomes or comparisons are examined. In general, the more questions tested, the greater the chance that at least one result may appear unusual by chance if no adjustment or prespecified hierarchy is used. The registry record does not report a multiplicity strategy, a hierarchy among outcomes, or analyses of the named secondary outcomes. It is therefore not possible to assess how multiple testing was handled.

Missing-data methods are also not reported in the registry record. The record does not describe the amount or pattern of missing observations, whether all enrolled participants contributed to each outcome, or whether any values were imputed. The primary endpoint is labeled as analyzed per patient, but the record does not explain the analysis population for the secondary outcomes or reconcile that designation with the sinus-level unit.

In general, missingness can affect interpretation when the availability of an outcome is related to treatment, participant characteristics, or the outcome itself. Appropriate handling depends on the reason data are missing and the analysis objective. Without information on missingness and analysis populations, the robustness of any outcome estimate cannot be assessed. Since the registry reports zero analyses, it does not provide estimates whose missing-data handling can be evaluated.

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.

For Pilot 15 mm, the registry lists 7 at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For Efficacy 25 mm, it lists 38 at risk and zeros for each of those categories. For Safety/PK 25 mm, it lists 5 at risk and zeros for each category. No serious adverse-event terms are listed.

These are registry counts, not a detailed safety analysis. A zero indicates that no event in the stated category was recorded in the posted result for that group; it does not establish the absence of every possible adverse event or resolve how long participants were followed. The registry record does not report the safety observation period, event definitions beyond the categories, completeness of follow-up, or how events were collected and adjudicated.

The groups also differ in their described treatment context: the efficacy groups involve unilateral placement, while the Safety/PK group involves bilateral placement. The counts should therefore be read in the context of those group descriptions, not combined into a single rate. No comparative safety estimate or uncertainty interval is reported. The posted figures describe recorded events only and do not support a broader conclusion about comparative safety.

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

The registry record establishes that a randomized study evaluated the Sinexus Intranasal Splint following FESS in patients with chronic rhinosinusitis. It defines a procedural primary endpoint based on successful deployment and describes both unilateral efficacy groups and a bilateral Safety/PK group. It also records the number of participants at risk and adverse-event counts for three labeled groups.

The primary endpoint’s definition is clear about the intended meaning of success: placement on the intended side at the conclusion of the implant procedure. However, the posted arm entries do not explain how their values relate to the defined numerator and denominator. The record does not report separate counts of successful deployments and attempted sinuses or a statistical comparison between the coated and non-coated splints. Thus, the registry information does not establish the size or precision of any comparative effect.

The recorded safety counts are zero in each listed adverse-event category across the three groups. Those counts describe what was entered in the registry and do not, without further information on event collection and follow-up, establish an absence of risk. The registry does not report numerical results for the four named secondary outcomes, and it reports no statistical analyses.

These limitations should not be mistaken for evidence that the devices performed the same way, that either device had a particular effect, or that no safety events occurred outside the posted categories. They mean that the information recorded is insufficient to quantify comparative performance or assess precision. More complete outcome definitions, component counts, analysis methods, and follow-up details would be needed for those questions. The posted record is best read as a description of the study and its recorded counts, rather than as a comparative efficacy analysis.

13. Why This Trial Matters Statistically

This trial is statistically notable because its stated primary endpoint is a procedural ratio, while the posted arm entries do not explain how their values map to that ratio. That distinction matters: a clearly defined endpoint is not enough to interpret a numerical result if the numerator, denominator, scale, or analysis unit cannot be identified. The record names ethmoid sinuses as the unit and describes analysis per patient, but does not explain the relationship between them.

The design also includes different treatment contexts. The efficacy question uses unilateral placement of coated and non-coated splints, while a separate group received bilateral coated splints for Safety/PK. Keeping those contexts distinct is important when interpreting counts or considering what comparison a result would answer. The registry does not report a statistical contrast among these groups.

From a biostatistical perspective, the absence of posted analyses is a central limitation. There is no treatment-effect estimate, confidence interval, or analysis of the named secondary outcomes. The registry lists four secondary outcomes, but does not report their results. Without estimates and methods, readers cannot judge precision, evaluate multiplicity handling, or assess how the endpoint’s patient-level designation was reconciled with the sinus-level unit.

The record nevertheless gives useful design context: randomized allocation, quadruple masking, a parallel structure, an enrollment of 50, and the groups’ broad intervention descriptions. It also provides adverse-event counts. These registry entries help identify the questions the study intended to address and the information that would be needed for a fuller analysis. They do not substitute for the missing comparative estimates or outcome details.

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.

Several limitations are specific to the information recorded for this trial. First, the primary endpoint is defined as a ratio, but the registry does not provide separate counts of successful deployments and attempted sinuses. The values attached to the arm entries are not explained in relation to that ratio. As a result, the listed values cannot be transparently interpreted as deployment-success rates.

Second, the endpoint metadata names ethmoid sinuses as the unit while describing the analysis population as per patient. The registry record does not explain whether multiple sinuses could contribute for one patient or how dependence between such observations was handled. This leaves the analysis unit and the independent observational unit unclear.

Third, the arm information combines a unilateral efficacy comparison, a bilateral Safety/PK group, and a Pilot 15 mm group. The record does not fully explain how each listed arm entry relates to the randomized-side descriptions or whether the reported values correspond to distinct analysis populations. It does not report comparative estimates, confidence intervals, or numerical results for the secondary outcomes.

Fourth, the record does not describe the missing-data approach, participant exclusions, analysis populations for each outcome, multiplicity strategy, interim analyses, or detailed statistical plan. It also does not give safety follow-up duration, event-collection procedures, or additional event definitions. These omissions limit interpretation of both efficacy and safety counts. They are limitations of the registry record; they do not establish that these details were absent from other study documents.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis — NCT00840970.
• Registry record last updated 2020-10-01; status last verified 2020-09.
• Results first posted 2020-10-01.
• 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, randomized, quadruple-masked, parallel study of the Sinexus Intranasal Splint following FESS in patients with chronic rhinosinusitis. Enrollment was 50. The primary endpoint was Device Success Rate, defined by successful placement on the intended side divided by attempted sinuses, with a Baseline timeframe.

The study descriptions include unilateral coated and non-coated splint placement for the efficacy comparison and bilateral coated placement in a Safety/PK group. The outcome entries list Pilot 15 mm, Efficacy 25 mm, and Safety/PK 25 mm groups. The record also names four secondary outcomes covering turbinate position, meatus patency, adhesion, and polypoid tissue changes.

The posted arm values are not explained in relation to the primary endpoint’s ratio definition. No statistical analyses or numerical secondary-outcome results are reported. Serious adverse events, other adverse events, and deaths are recorded as zero in each listed group. The record does not report further details on missing data, analysis methods, or safety follow-up.