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 Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia (NCT02228720), a na na study. The primary outcome is Device Placement Success Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02228720 |
| Phase | NA |
| Condition | Chronic Sinusitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Intersect ENT |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with chronic sinusitis undergoing sinus surgery involving peripheral sinus ostia. Its primary endpoint population was attempted frontal and maxillary sinus ostia. The registry record reports enrollment of 15, but does not report participant characteristics or the number of sinuses actually attempted.
Intervention
The intervention was the Propel Nova Sinus Implant, described as a bioabsorbable, steroid-releasing sinus implant. The record states that it releases 370 mcg of mometasone furoate over 30 days. The study description frames the work as an assessment of performance, safety, and initial signals of efficacy in this surgical setting.
Comparator
No comparator group is listed. The record identifies the study as single group, with allocation recorded as NA and masking as NONE. Therefore, the study does not directly compare implant placement with another device, no implant, or an alternative procedure. Its results cannot establish a between-group treatment effect.
Primary question
The primary question was whether the implant could be successfully accessed and placed in a frontal or maxillary sinus ostium within two attempts. The endpoint is defined as a proportion: successful placements form the numerator, and attempted sinuses form the denominator. The success-rate result itself is not reported in the registry record, so the central feasibility outcome cannot be quantified from that record.
3. Trial Design
The EXCEED Study, registered as NCT02228720, evaluated the Propel Nova Sinus Implant in peripheral sinus ostia. The registry describes it as a feasibility study in people with chronic sinusitis undergoing sinus surgery. Its stated aims were to assess device performance and safety and to look for initial signals of efficacy. The record identifies Intersect ENT as the sponsor.
This was a single-group study, not a randomized comparison. Allocation is recorded as NA, and masking is recorded as NONE. The intervention listed is the Propel Nova Sinus Implant; no control intervention or comparator group is described. Consequently, the design can describe placement and observed events in the study group, but it cannot isolate a comparative effect against another approach.
Enrollment is listed as 15. The record gives a start date of 2014-06, a primary completion date of 2014-10, and a status of COMPLETED. These record entries describe the study timeline and status; they do not establish that every enrolled participant completed every assessment. Completion status also does not substitute for outcome results.
The primary outcome is Device Placement Success Rate, assessed at the baseline procedure. It concerns attempted frontal and maxillary sinus ostia, with success defined by access and placement within two attempts. Secondary outcomes listed are ostial patency, adhesion/scarring grade 2 & 3, degree of inflammation, and Sino-Nasal Outcome Test (SNOT) 22. Although the record lists five outcome measures, it does not report numerical findings for these endpoints. The phase is recorded as NA. Details such as eligibility criteria, recruitment setting, follow-up schedule, and participant flow 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.
Open Label - Baseline
| Stage | Propel Nova Sinus Implant |
|---|---|
| STARTED | 15 |
| COMPLETED | 15 |
| NOT COMPLETED | 0 |
Open Label - Day 30
| Stage | Propel Nova Sinus Implant |
|---|---|
| STARTED | 15 |
| COMPLETED | 14 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Propel Nova Sinus Implant |
|---|---|
| Lost to Follow-up | 1 |
Open Label - Day 90
| Stage | Propel Nova Sinus Implant |
|---|---|
| STARTED | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Attempted frontal and maxillary sinus ostia
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: All patients and sinuses in whom placement of a Propel Nova Sinus Implant was attempted.
| Characteristic | Unit | Propel Nova Sinus Implant |
|---|---|---|
| Participants analysed | 15 | |
| Age, Continuous | years | 50.6 (SD 13.24) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 13 |
| Lund-Mackay Score (CT scan): Frontal Sinuses | units on a scale | 2.5 (SD 1.19) |
| Lund-Mackay Score (CT scan): Maxillary Sinuses | units on a scale | 2.3 (SD 0.98) |
6. Primary Endpoint
The registry lists the primary outcome as Device Placement Success Rate, measured over Baseline Procedure.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of attempted sinuses |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is a procedural feasibility measure: the proportion of attempted sinuses in which the implant was successfully accessed and placed within two attempts. Its numerator is the number of successful device placements, and its denominator is the number of attempted sinuses. The stated population includes attempted frontal and maxillary sinus ostia, and the time frame is the baseline procedure.
A placement endpoint is relevant to a feasibility study because it focuses on whether the device can be delivered to the intended anatomical site under the specified procedural criterion. It is distinct from a clinical symptom outcome or a measure of longer-term sinus patency. A successful placement, by itself, does not establish that a device improves health outcomes or remains effective over time.
The unit is attempted sinuses, not participants. The registry record does not report the number of attempted sinuses, successful placements, or the resulting proportion. Thus, the definition is available, but the observed success rate and its precision are not reported in the registry record. It is also not reported how any multiple sinus attempts within a participant were handled in statistical analyses.
In general, a proportion is more informative when accompanied by an uncertainty interval, because the interval conveys how precisely the underlying rate is estimated. No estimate or interval for this endpoint is reported in the registry record. The endpoint therefore cannot be used to quantify placement performance from the record alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record supplies the purpose and definition of the primary endpoint, but not its observed value. It does not report the number of attempted sinuses, the number of successful placements, a success proportion, or an uncertainty interval. As a result, the primary feasibility outcome cannot be interpreted as a numerical estimate. A definition of success is not evidence that success occurred at any particular rate.
The design also shapes what the study can address. With a single group and no listed comparator, observations can describe what happened among participants treated with the implant, but they cannot establish how those observations differ from outcomes under another approach. Allocation is recorded as NA and masking as NONE. No comparative treatment effect can be estimated from the design information recorded.
The study's stated purpose includes performance, safety, and initial efficacy signals. Those aims should not be confused with reported findings. Ostial patency, adhesion/scarring grade 2 & 3, degree of inflammation, and SNOT 22 are listed as secondary outcomes, but their results are not reported in the registry record. The record lists five outcome measures and zero analyses; it does not provide endpoint estimates, tests, or confidence intervals for the listed outcomes.
The adverse-event summary does include participant counts. It lists 15 participants at risk for serious events, with 1 affected, and 15 at risk for other events, with 9 affected. Squamous Cell Carcinoma appears as the top serious-event term with 6.7%. These figures describe the registry's safety summary; the record does not establish that an event was caused by the implant. The death count is not reported in the registry record.
In general, precision depends on the amount of information and the variability in the observations. Without the primary outcome count and an interval, the precision of the placement estimate cannot be assessed. The enrollment of 15 does not, by itself, reveal how many sinus attempts contributed to that endpoint or how stable an estimate would be. The posted information therefore supports a description of the study design and recorded safety counts, but not a numerical conclusion about placement success or efficacy.
9. Statistical Methods Explained
The statistical information in a registry entry has to be read alongside the study design and the endpoint definition. In this record, the design is single group, the primary endpoint is a proportion of attempted sinuses, and no primary result is reported. The registry also lists zero analyses. Those details limit which statistical conclusions can be drawn: an endpoint definition explains what was intended to be measured, while an analysis result is needed to quantify what was observed.
What does a placement proportion represent?
In general, a proportion divides the number of observations meeting a defined criterion by the number of eligible observations assessed. For the primary endpoint, a successful access and placement within two attempts meets the criterion, and attempted sinuses supply the denominator. The resulting proportion would describe the observed placement rate for the assessed attempts. It would not, on its own, describe symptom improvement, long-term patency, or a causal effect relative to another procedure.
The registry record does not report either count needed to calculate the primary proportion. It also does not report an interval around the estimate. A confidence interval is a statistical range expressing uncertainty around an estimate under a specified method; it is not a guarantee that the true value lies within that range. Without an endpoint estimate and interval, neither the observed rate nor its precision can be assessed from the registry record.
Why does the unit of analysis matter?
The endpoint is defined for attempted sinuses, whereas enrollment is reported for participants. These are different units. In general, when a participant can contribute more than one observation, observations from the same participant may be related rather than independent. Statistical methods may need to account for that clustering when estimating uncertainty. The registry record does not report the number of attempted sinuses or how repeated sinus-level observations were handled, so the analysis approach cannot be evaluated.
The registry identifies the primary measure as a number-type outcome and the study as single group. It does not report a statistical model, an estimation procedure, a hypothesis test, or a confidence-interval method. There is therefore no basis for attributing a particular analytical method to the study. A simple proportion may be a natural descriptive summary for the endpoint, but the record does not say how the sponsor analyzed it.
How does the design affect interpretation?
In general, a controlled comparison estimates a difference between groups, while a single-group study describes observations within the treated group. This study has no comparator group listed, so it does not support a direct contrast with an alternative intervention. Allocation is recorded as NA, and masking as NONE. Neither the study title nor the stated efficacy aim supplies a missing comparison.
The record's sample-size planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of an observed effect. Those assumptions are planning descriptions, not observed findings. They do not match the recorded single-group design as a description of the enrolled comparison, and no numerical planning estimates are reported in the registry record. Planning calculations, in general, are not observed power and cannot replace an outcome estimate.
What can the safety counts tell us?
In general, participant counts affected by adverse events describe how many participants had events in a stated category, not how many separate event episodes occurred or whether the intervention caused them. The registry reports serious and other adverse-event categories separately, with 15 at risk in each category. It reports 1 affected by serious events and 9 affected by other events. The summary names Squamous Cell Carcinoma as a serious-event term with 6.7%. No causal attribution or event-level detail is reported in the registry record.
For a proportion based on a small group, uncertainty can be substantial; an interval helps readers distinguish the observed rate from the range of values compatible with the data and the chosen method. That general principle applies to both procedural and safety proportions. The record does not report intervals or a method for computing them. Nor does it report enough detail to assess the timing, duration, or participant-level overlap of the adverse events.
What remains unknown about the analysis?
The record does not report analysis populations, treatment of missing observations, protocol deviations, or sensitivity analyses. It also does not report whether any adjustments were made for multiple outcome assessments. These are consequential details: in general, missing observations can change which participants contribute to an estimate, and multiple tests can increase the chance of a chance-positive finding if results are interpreted without appropriate context. These general considerations do not establish that a particular problem occurred in this study. They identify information that is not reported in the registry record and that would be needed for a fuller statistical appraisal.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and four named secondary outcomes: ostial patency, adhesion/scarring grade 2 & 3, degree of inflammation, and SNOT 22. It also lists five outcome measures overall. Assessing several endpoints raises a general multiplicity issue: when many hypotheses are tested, the chance of at least one apparently positive result can increase unless the analysis plan accounts for the family of tests. This is a general statistical concern, not evidence that the study reported positive findings.
The registry record lists zero analyses and does not report results for the primary or secondary outcomes. It does not state whether any multiplicity adjustment was planned or used, how outcomes were prioritized beyond identifying the primary measure, or whether analyses were exploratory. Those details are not reported in the registry record. Without analysis results, no claim about statistical significance or multiplicity-adjusted inference is possible.
Information about missing data is also not reported in the registry record. The record does not describe the number of participants or sinus attempts assessed at each time point, reasons for missing observations, or methods for handling missing values. Enrollment of 15 does not establish how many observations were available for each endpoint. In general, missingness can affect an estimate when the observed cases differ from those without measurements, so the flow of observations and the analysis method matter.
Analysis populations are not reported in the registry record. It is not stated whether analyses used all enrolled participants, only those who received the implant, or another defined group. The procedural endpoint is based on attempted sinuses, but the record does not explain how that unit relates to the population used for any secondary outcome analysis. These omissions prevent a complete account of who contributed to each estimate and how the reported findings, if any, should be interpreted.
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 |
|---|---|---|---|
| Propel Nova Sinus Implant | 1 | 15 | 6.7% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Propel Nova Sinus Implant | 9 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | Propel Nova Sinus Implant |
|---|---|---|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Propel Nova Sinus Implant |
|---|---|---|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | 3 of 15 |
| Acute Sinusitis | Infections and infestations | 1 of 15 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | 1 of 15 |
| Chronic Sinusitis | Respiratory, thoracic and mediastinal disorders | 1 of 15 |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | 1 of 15 |
| Upper Respiratory Infection | Infections and infestations | 1 of 15 |
| Vasovagal Reaction | General disorders | 1 of 15 |
| Sinus Drainage, green | Respiratory, thoracic and mediastinal disorders | 1 of 15 |
| Crusting in nares | Respiratory, thoracic and mediastinal disorders | 1 of 15 |
Serious events with the highest arm-level rate: squamous cell carcinoma (6.7%).
The registry's adverse-event summary lists 15 participants at risk for serious adverse events and 1 affected. For other adverse events, it lists 15 at risk and 9 affected. These are participant counts in the categories reported by the registry, not a complete description of event timing, duration, severity, or number of episodes. The two categories should not be added together: the record does not state whether participants could appear in both.
Squamous Cell Carcinoma is listed as the top serious-event term, with 6.7%. The registry entry does not establish from this term alone whether the event was judged related to the device or procedure, or provide context about its onset or clinical course. The reported event should therefore be read as a safety entry, not as evidence of causation.
The death count is not reported in the registry record. A missing death count should not be interpreted as a reported count of zero. More detailed information about adverse-event definitions, event-level counts, attribution, and follow-up is not reported in the registry record. The available summary can describe the listed counts, but it cannot fully characterize the safety profile.
12. What the Result Does, and Does Not, Mean
The study asks a focused procedural question: can the implant be accessed and placed in an intended frontal or maxillary sinus ostium within two attempts? That question is relevant to feasibility in the surgical setting described by the record. However, the registry does not report the primary success count or success rate. The central result therefore cannot be judged from the record, and the listed endpoint definition should not be mistaken for a demonstrated performance level.
The implant is described as bioabsorbable and steroid-releasing, with 370 mcg of mometasone furoate released over 30 days. That description identifies the intervention; it does not show what happened to participants or establish a clinical effect. The secondary outcomes include measures of ostial patency, scarring, inflammation, and SNOT 22, but their findings are not reported in the registry record.
The single-group design is important. Without a listed comparator, observed outcomes cannot be directly contrasted with outcomes under another approach. The record's stated goal of assessing initial efficacy signals does not turn a feasibility study into a controlled test of efficacy. Even if an outcome estimate were available, interpretation would require attention to its precision, assessment timing, and the clinical context; those details are not reported in the registry record.
The safety summary reports 1 participant affected by serious adverse events and 9 affected by other adverse events, with 15 at risk in each category. It also lists Squamous Cell Carcinoma at 6.7% among the serious-event terms. Those entries are descriptive. They do not establish that the implant caused an event, and the registry does not report the death count.
In general, a small feasibility study can provide information about whether a procedure is practicable and help identify questions for further study. It cannot, by itself, establish comparative benefit or rule out uncommon harms. For this record, the absence of the primary and secondary results further limits interpretation: no numerical conclusion about placement success, patency, symptoms, inflammation, or scarring can be drawn from the registry entry.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary question is tied to a practical procedure rather than a comparative clinical outcome. The endpoint asks whether placement succeeds within a specified attempt criterion. That focus can be useful in feasibility research, where delivery to the intended site is a necessary operational question before broader clinical effects can be assessed.
The endpoint's denominator is attempted sinuses, not enrolled participants. That distinction matters because participant enrollment does not reveal the number of endpoint observations. It also raises a general analysis consideration: if participants contribute multiple sinus observations, those observations may be correlated. The registry does not report the number of attempts or the method used to account for any within-participant dependence.
The single-group design makes descriptive interpretation central. It can describe recorded outcomes in the group receiving the implant, but without a comparator it cannot estimate a difference against another approach. The record identifies no masking and does not report inferential analyses. This makes it especially important not to read the stated study aims as results.
Transparency about missing outcome results is itself important. The record defines the placement endpoint and names secondary outcomes, but does not report their estimates. As a result, readers can understand what the study intended to measure but cannot evaluate how often placement succeeded or how precisely any clinical outcomes were estimated. The adverse-event counts add limited descriptive safety information, but do not resolve questions of attribution or event context.
For biostatistical interpretation, this trial illustrates the difference between a measurable endpoint, a study design, and a reported result. Each contributes a different kind of information. A clear endpoint definition supports reproducibility; an appropriate design determines which comparisons are possible; and numerical estimates with uncertainty are needed to assess observed outcomes. Here, the record makes the first two elements more visible than the third.
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 principal limitation for interpretation is that the registry record does not report the primary placement-success result. It gives neither the number of attempted sinuses nor the number successfully treated, and it provides no uncertainty interval. The primary question therefore remains unquantified in the available record.
The study is single group, with no comparator listed and masking recorded as NONE. This restricts the analysis to description rather than a direct comparison with another intervention. Enrollment is 15, but the number contributing to each outcome is not reported. Participant characteristics, eligibility details, and the number of attempted sinuses are also not reported in the registry record.
Secondary outcome names are listed, but their results and assessment details are not reported. The record does not specify outcome-specific analysis populations, missing-data handling, or multiplicity procedures. It also does not describe whether multiple sinus observations within a participant were addressed statistically. These gaps make it difficult to evaluate precision and the assumptions underlying any analysis.
The safety summary provides participant counts and a serious-event term, but does not report event timing, duration, attribution, or detailed event-level information. The death count is not reported in the registry record. As a result, the summary is insufficient for a complete appraisal of adverse-event context.
The record gives a start date of 2014-06 and a primary completion date of 2014-10, but the follow-up schedule and duration for individual outcomes are not reported. The status is COMPLETED; that status does not indicate that all planned data are available in the registry. Taken together, the study description is clearer than the outcome evidence available in the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia — NCT02228720.
- Registry record last updated 2017-08-04; status last verified 2017-04.
- Results first posted 2017-08-04.
- 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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18. Record Summary
NCT02228720 is the EXCEED Study, a completed, single-group feasibility study sponsored by Intersect ENT. It evaluated the Propel Nova Sinus Implant in people with chronic sinusitis undergoing sinus surgery of peripheral sinus ostia. Enrollment is listed as 15; the start date is 2014-06 and the primary completion date is 2014-10.
The primary endpoint was placement success within two attempts, expressed as successful placements among attempted frontal and maxillary sinus ostia. The registry record does not report the endpoint result. It lists ostial patency, adhesion/scarring grade 2 & 3, degree of inflammation, and SNOT 22 as secondary outcomes, without reported results. The adverse-event summary lists 1 participant affected by serious events and 9 by other events, with 15 at risk in each category. No comparator is listed, and allocation is recorded as NA.