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 Healthcare Utilization and Outcomes of FinESS Treatment in the Office (NCT00986830), a na na study. The primary outcome is Sino-Nasal Outcomes Test.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00986830 |
| Phase | NA |
| Condition | Rhinosinusitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 74 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Entellus Medical, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with rhinosinusitis treated in a physician’s office using FinESS Sinus Treatment. The primary endpoint population was treated participants with both baseline and 12-month SNOT-20 scores; the number meeting that definition is not reported in the registry record.
Intervention
Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Comparator
There was no randomized or concurrent control group. The study is recorded as single group, with allocation listed as NA.
Primary question
What were participants’ SNOT-20 scores at baseline and 12 months after the procedure? The registry record specifies these measurement times but does not report the score results or the change between them.
The study’s stated purpose was to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy performed in the physician’s office. Its primary outcome was the Sino-Nasal Outcomes Test, a patient-reported measure of rhinosinusitis symptom burden. The registry also lists symptom domains from the Rhinosinusitis Symptom Inventory, medication-use outcomes, and device- or procedure-related adverse events as secondary outcomes.
The clinical question is therefore descriptive rather than a randomized comparison of treatment strategies. The record can identify the procedure and the intended outcomes, but without a control group it cannot separate changes after the procedure from changes that might have occurred over time for other reasons. The missing SNOT-20 results also prevent assessment of the size and precision of any observed change.
3. Trial Design
This was a prospective, nonrandomized, single-group trial of FinESS Sinus Treatment. The registry lists the allocation as NA and masking as none. The listed intervention was balloon dilation of the maxillary sinuses using the device, with treatment described as taking place in the physician’s office. The record gives an enrollment of 74 and lists the study status as completed.
The study began in 2009-09, and its primary completion date was 2012-09. The phase is listed as NA. Entellus Medical, Inc. is named as the sponsor. These registry entries describe the study’s administrative and design context; they do not establish how participants were selected, whether all enrolled participants received the procedure, or how many contributed data to each outcome. Those details are not reported in the registry record.
The primary outcome was SNOT-20, assessed at baseline and 12 months post procedure. Its defined population was all treated participants with scores at both times. Secondary outcomes included four RSI symptom domains, participant counts for use of nasal steroids, antihistamines, and antibiotics, and device- and/or procedure-related adverse events. The registry lists 9 outcome measures and 8 analyses, but the reason for that difference and the analysis details are not reported in the registry record.
Because the design has one group and no randomized control, the baseline-to-follow-up assessment is not a like-for-like comparison between assigned treatment groups. Any change over time would be an observed within-group change. The registry record does not report a protocol-based comparator, a statistical analysis plan, or enough outcome results to evaluate the primary endpoint.
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 | Balloon Dilation |
|---|---|
| STARTED | 74 |
| Treated | 69 |
| COMPLETED | 66 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | Balloon Dilation |
|---|---|
| Death | 1 |
| Lost to Follow-up | 1 |
| Lack of Efficacy | 1 |
| Unable to access sinus with device | 5 |
Analysis population for the primary outcome, as defined in the registry: All treated participants with baseline and 12-month SNOT-20 scores.
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 enrolled participants treated with the FinESS Sinus Treatment device.
| Characteristic | Unit | Balloon Dilation |
|---|---|---|
| Participants analysed | 69 | |
| Age, Continuous | years | 47.1 (SD 14.4) |
| Sex: Female, Male: Female | Participants | 44 |
| Sex: Female, Male: Male | Participants | 25 |
| Region of Enrollment: United States | Participants | 69 |
| Previous sinus surgery | Participants | 7 |
| Affected sinuses: Maxillary only | Participants | 55 |
| Affected sinuses: Maxillary and anterior ethmoid | Participants | 14 |
6. Primary Endpoint
The registry lists the primary outcome as Sino-Nasal Outcomes Test, measured over Baseline and 12 months post procedure.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the Sino-Nasal Outcomes Test, or SNOT-20, a validated, disease-specific patient-reported instrument intended to indicate the severity of rhinosinusitis symptoms. It asks about 20 symptoms, each scored from 0, meaning “no problem,” to 5, meaning “problem as bad as it can be.” The overall score is the average of the symptom scores and ranges from 0 to 5; higher scores indicate worse symptoms.
The registry describes the endpoint as a mean score with standard deviation, measured at baseline and 12 months post procedure. It identifies the population as treated participants with SNOT-20 scores at both time points. This repeated measurement can describe how scores in that population differed over time. Since there is no concurrent control group, such a difference would not by itself establish that the procedure caused the change.
The registry states that a reduction of 0.8 or more in the overall SNOT-20 score is the minimal clinically important difference. That threshold offers context for interpreting a reported change, but it does not replace an estimate of the change or its uncertainty. The baseline and follow-up means, standard deviations, change estimate, and confidence interval are not reported in the registry record. Consequently, the degree of symptom change and its precision cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clear measurement plan for the primary endpoint: SNOT-20 at baseline and 12 months after the procedure, summarized as a mean and standard deviation among treated participants with scores at both times. However, the corresponding numerical results are not reported in the registry record. No baseline mean, follow-up mean, change estimate, standard deviation, confidence interval, or p-value is available in the information reported. Thus, there is no posted primary-endpoint estimate to interpret for direction, magnitude, or precision.
The SNOT-20 scale runs from 0 to 5, with higher scores indicating worse symptoms. The record gives a reduction of 0.8 or more as the minimal clinically important difference. In general, this threshold can help contextualize a change in the score, while the estimate and its confidence interval indicate how precisely that change is measured. Here, the record does not report a change estimate or interval, so it is not possible to determine whether the observed change met the stated threshold or how compatible the data are with changes of different sizes.
The study is single group and nonrandomized. Even if a baseline-to-follow-up change were reported, it would be a within-group change rather than a contrast with a randomized control group. General statistical interpretation therefore needs to distinguish change over time from an effect attributable to the procedure. Other influences on symptoms or on follow-up measurements cannot be ruled out by this design alone.
The registry describes the study purpose as evaluating postoperative healthcare resource utilization. It also lists symptom domains, medication use, and adverse events among the secondary outcomes. Their numerical results are not reported in the registry record in the information, so no conclusion about those outcomes can be drawn from the outcome list alone. The status is completed, but completion does not substitute for outcome estimates.
The record’s safety figures list 0 participants with serious adverse events, 9 in the other adverse-event category, and 1 death in the Balloon Dilation group, with 74 at risk in the relevant registry entries. These are descriptive registry counts. The record does not report the event narratives, timing, or attribution details needed to characterize those outcomes further. Counts alone do not establish whether an event was caused by the device or procedure.
Overall, the registry provides the design, outcome definitions, and some safety counts, but not the primary efficacy results. The appropriate reading is that the record does not permit a quantitative assessment of the SNOT-20 outcome. It also does not support a causal comparison, because no control group is described.
9. Statistical Methods Explained
For a continuous outcome such as SNOT-20, a mean describes the average score in the analyzed population, while a standard deviation describes how dispersed individual scores are around that mean. These summaries answer different questions: the mean describes the central level, and the standard deviation describes variability among participants. They do not, on their own, show how precisely the mean or a change in the mean has been estimated.
What would a confidence interval add?
In general, a confidence interval expresses uncertainty around an estimate under the assumptions of the statistical method used. A narrower interval indicates greater precision than a wider interval, though precision is not the same as clinical importance or freedom from bias. For a change in SNOT-20, an interval would help readers judge which values remain compatible with the data. The registry record does not report a confidence interval for the primary outcome.
How should the scale be read?
The overall SNOT-20 score averages responses across 20 symptoms and ranges from 0 to 5. Higher scores indicate worse symptoms. The record states that a reduction of 0.8 or more is the minimal clinically important difference. In general, a threshold of this kind provides a reference for interpreting the size of a change; it is not a substitute for the actual estimate, its uncertainty, or the study design. Neither baseline and follow-up means nor a change estimate is reported in the registry record.
What does a single-group comparison show?
In general, a before-and-after comparison describes how the measured outcome differs between two time points for the participants included in the analysis. Without a concurrent control group, it cannot isolate the contribution of the procedure from other changes over time. Nonrandomized follow-up may also be affected by who returns for measurement and who has complete scores. The registry defines the primary population as treated participants with both baseline and 12-month scores, but the number analyzed and the handling of missing scores are not reported in the registry record.
What is the role of a p-value?
In general, a p-value assesses how compatible observed data are with a specified null hypothesis under a statistical model. It does not measure the size or importance of an effect, and it does not show the probability that a hypothesis is true. Interpretation should be alongside an effect estimate and its uncertainty. The primary outcome’s p-value and the statistical test used are not reported in the registry record, so no significance claim can be evaluated.
Why might over-dispersion matter?
General statistical methods for counts often rely on assumptions about how much variability is expected. Over-dispersion means that observed variability exceeds what a simple model assumes. If ignored, uncertainty can be understated, making intervals too narrow or tests too optimistic. This consideration can matter for event counts or resource-use outcomes, depending on how they are measured and analyzed. The registry record does not report the distributions, models, or diagnostics for healthcare utilization or event outcomes, so it is not possible to determine whether over-dispersion was relevant or addressed.
How should planning illustrations be interpreted?
The record describes a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not observed trial results or evidence of the study’s original design. The illustration is not observed power. The record does not report the trial’s own sample-size justification, and a single-group study should not be mistaken for the hypothetical two-arm allocation used in a planning calculation. Without the underlying observed effect or the resulting planning values in the registry record, the illustration cannot establish how adequately the study was designed to detect a clinically meaningful change.
More generally, a statistical result is most informative when its estimand, analysis population, missing-data handling, model, effect estimate, and uncertainty are clear. The registry describes some of these elements, especially the endpoint, measurement times, and eligible primary-outcome population. It does not report the primary outcome estimates or enough analysis detail to reconstruct or evaluate the statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 9 outcome measures and 8 analyses. It names multiple secondary outcomes, including four RSI symptom domains, use of three medication categories, and device- and/or procedure-related adverse events. A collection of outcomes raises a general multiplicity issue: when many outcomes are tested, the chance of at least one apparently unusual result can increase if no adjustment or prioritization is used. The registry record does not report a multiplicity strategy, a hierarchy of outcomes, or which results were considered confirmatory.
The primary outcome population is defined as treated participants with baseline and 12-month SNOT-20 scores. This is a complete-score definition for the stated endpoint, but the record does not report how many participants met it, how many lacked either measurement, or why data were missing. It also does not report whether missing outcomes were imputed, whether analyses used available cases, or whether sensitivity analyses assessed the effect of missingness. In general, missing follow-up data can affect both the precision and the interpretation of a longitudinal estimate, especially if having a measurement is related to participants’ health or experience.
The registry does not report the statistical analysis plan, interim analyses, or the methods used for each listed outcome. It is therefore not possible to determine whether outcome selection, multiplicity, or missing data were addressed in a particular way. The difference between the listed numbers of outcome measures and analyses is not explained in the registry record.
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 |
|---|---|---|---|
| Balloon Dilation | 0 | 74 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Balloon Dilation | 1 of 74 |
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 |
|---|---|
| Balloon Dilation | 9 of 74 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Balloon Dilation |
|---|---|---|
| Numbness | Injury, poisoning and procedural complications | 9 of 74 |
For the Balloon Dilation group, the registry lists 74 participants at risk for the serious-event entry and 0 participants affected by serious adverse events. It lists 74 at risk for the other adverse-event entry and 9 participants affected in that category. The record also lists 1 death. These are counts, not estimates of comparative risk: the study has no randomized control group, and no comparative safety analysis is reported.
The registry record does not report event descriptions, timing, duration, severity details beyond the serious-event category, or whether the death or other events were judged related to the device or procedure. It also does not report enough follow-up detail to establish how completely events were collected. Therefore, the counts should be read as registry summaries rather than as a complete account of the circumstances or causes of each event. A zero count in the serious category does not by itself establish that serious harms are impossible or that the procedure is free of risk.
12. What the Result Does, and Does Not, Mean
This trial record describes a prospective evaluation of FinESS balloon dilation in a physician’s office, with postoperative healthcare resource utilization as its stated purpose and SNOT-20 as its primary outcome. It specifies the score’s meaning, the baseline and 12-month assessment times, and the population intended for the primary analysis. It also gives some adverse-event counts. These details help readers understand what the study was designed to observe.
The registry record does not report the primary SNOT-20 results. Without the baseline and follow-up scores, a change estimate, and its uncertainty, the record cannot show how large or precise any symptom change was, or whether it met the stated minimal clinically important difference of a reduction of 0.8 or more. The outcome definitions and planned measurement times are not themselves evidence of an observed benefit or harm.
Even if a within-group change were available, the study’s single-group, nonrandomized design would limit causal interpretation. A before-and-after difference would not establish what would have happened without the procedure. There is no like-for-like randomized comparison in the registry description, and the record does not report a control group.
The listed safety counts are descriptive and do not establish that an event was caused by treatment. The registry does not provide event narratives or attribution details. Nor does the record report outcome information sufficient to assess the listed symptom domains, medication-use outcomes, or healthcare utilization. The appropriate conclusion is limited: the study’s purpose and methods are described, but its primary outcome results are not reported in the registry record, so the central outcome cannot be quantitatively interpreted from this information.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between an outcome definition and an outcome result. The registry explains what SNOT-20 measures, how the score is oriented, when it was intended to be collected, and what reduction is considered minimally important. Those details are necessary for interpretation, but they do not reveal the observed score or the uncertainty around it. When results are absent, readers should not infer them from the study’s completion status or from its stated objectives.
The design also illustrates why a before-and-after study and a controlled comparison answer different questions. Repeated measurements can describe change in the followed group. A concurrent control can help distinguish that change from temporal influences, while randomization can reduce systematic differences between comparison groups. This record describes a single group and no randomized comparator, so its design does not support the same causal interpretation as a randomized comparison.
The endpoint’s stated minimal clinically important difference is useful context because statistical evidence should be considered in terms of both magnitude and precision. A difference that is statistically detectable is not automatically clinically important, and a clinically meaningful threshold cannot be assessed without an observed estimate. Here, the primary endpoint results are not reported in the registry record.
Finally, the safety counts show why descriptive event reporting should be kept separate from causal attribution. Counts can identify events recorded in a study, but interpretation also depends on event definitions, timing, follow-up, and relatedness assessments. Those details are not reported in the registry record. Together, the design and reporting make this record a useful reminder to distinguish what was measured, what was observed, and what conclusions the evidence 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 primary limitation for interpretation is that the registry record does not report the SNOT-20 results. It gives no baseline or 12-month mean, standard deviation, change estimate, confidence interval, or p-value. As a result, the stated primary endpoint cannot be quantitatively assessed, and the minimal clinically important difference cannot be compared with an observed change.
The design is nonrandomized and single group, with no concurrent control. Any reported within-group change would therefore be vulnerable to influences other than the procedure, and it would not establish a causal effect. Masking is listed as none, which is relevant for a patient-reported outcome because participants know they received the procedure; the record does not describe any steps taken to address possible response effects.
The endpoint population requires both baseline and 12-month scores, but the number of participants in that population and the handling of missing measurements are not reported in the registry record. The record also does not describe the statistical analysis plan, multiplicity handling, outcome-specific models, or whether sensitivity analyses were conducted. The listed number of outcome measures differs from the listed number of analyses, and the reason is not reported.
For safety, the registry gives counts but not event narratives, timing, or attribution details. For the secondary outcomes, their names are listed but numerical results and analysis details are not reported in the registry record. These reporting limitations prevent fuller assessment of the study’s outcomes, beyond its stated design and the available descriptive safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Healthcare Utilization and Outcomes of FinESS Treatment in the Office — NCT00986830.
- Registry record last updated 2020-10-27; status last verified 2020-10.
- Results first posted 2020-10-27.
- 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
NCT00986830 is a completed, prospective, nonrandomized, single-group study sponsored by Entellus Medical, Inc. It evaluated FinESS balloon dilation of the maxillary sinuses in a physician’s office. Enrollment is listed as 74; the study began in 2009-09, and primary completion was 2012-09.
The primary outcome was mean SNOT-20 score at baseline and 12 months post procedure, among treated participants with scores at both times. The registry defines the instrument and gives a minimal clinically important difference of a reduction of 0.8 or more, but the primary outcome results are not reported in the registry record. Secondary outcomes include RSI symptom domains, medication use, and device- and/or procedure-related adverse events. The Balloon Dilation safety entries list 0 participants with serious adverse events, 9 in the other adverse-event category, and 1 death. The record does not provide the event details needed to interpret attribution.