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 A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF) (NCT04614324), a na na study. The primary outcome is Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04614324 |
| Phase | NA |
| Condition | Chronic Rhinitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 129 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Aerin Medical |
| Results posted | Yes |
2. Clinical Question
Population
Participants with chronic rhinitis were enrolled in a post-market study. The record lists 129 participants as enrolled and describes assessment of nasal symptoms using the reflective Total Nasal Symptoms Score. Further eligibility details and characteristics of the enrolled participants are not reported in the registry record.
Intervention
The intervention was the RhinAer procedure, performed in the study clinic using the RhinAer Stylus and Aerin Console. The Stylus is described as a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Console. Additional procedural details are not reported in the registry record.
Comparator
This was a single-group study, with no like-for-like control group identified in the registry record. Allocation is listed as not applicable and masking as none. The principal comparison is therefore the group’s rTNSS at baseline and three months after the procedure, rather than a comparison between treatment groups.
Primary question
The primary endpoint asks for the mean change in rTNSS from baseline to three months after the study procedure. The registry record describes the measure and its timing, but the mean change and its 95% confidence interval are not reported in the registry record. Thus, the record does not provide the numerical primary result needed to assess the observed size and precision of change.
3. Trial Design
This was a prospective, open-label, multicenter study of the RhinAer procedure in participants with chronic rhinitis. The study is classified as single-group, with allocation listed as not applicable and masking listed as none. The record describes one treatment arm, RhinAer ARC Stylus Treatment. No randomized or concurrent control arm is identified, so the design does not support a direct between-group treatment comparison.
The study is described as post-market and as continuing evaluation of the device for chronic rhinitis. The record lists 129 participants enrolled and gives the status as completed. The listed study start was 2020-10-05, and primary completion was 2021-06-30. These record entries describe the study timeline, but do not establish how many participants completed each follow-up assessment or were included in each analysis.
The procedure was performed in the study clinic with the RhinAer Stylus and Aerin Console. The device description states that the Stylus can deliver bipolar radiofrequency energy to tissue when connected to the Console. Details such as the exact treatment protocol, procedural standardization across centers, and operator experience are not reported in the registry record.
The primary outcome was mean change in rTNSS from baseline to three months post-procedure. Listed secondary outcomes include participant responder percentage, Mini Rhinoconjunctivitis Quality of Life Questionnaire change at three and six months, device-related adverse events, rTNSS scores at three and six months, and rTNSS change from baseline at six months. The record lists eight outcome measures and no analyses. Numerical results for the primary endpoint are not reported in the registry record.
The single-group, open-label design can describe change over time in the observed participants, but it cannot isolate the procedure’s effect from other influences on scores. A control group, masking, and additional design details 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.
Before assignment: There was no wash out or run in for this study
Overall Study
| Stage | Treatment Arm |
|---|---|
| STARTED | 129 |
| 3Month | 128 |
| 6 Month | 123 |
| COMPLETED | 0 |
| NOT COMPLETED | 129 |
Reasons for not completing this period:
| Reason | Treatment Arm |
|---|---|
| Lost to Follow-up | 3 |
| Physician Decision | 1 |
| Withdrawal by Subject | 2 |
| Remaining in Follow up | 123 |
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 | Treatment Arm |
|---|---|---|
| Participants analysed | 129 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 105 |
| Age, Categorical: >=65 years | Participants | 24 |
| Sex: Female, Male: Female | Participants | 69 |
| Sex: Female, Male: Male | Participants | 60 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 123 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 |
| Race (NIH/OMB): White | Participants | 117 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Body Mass Index: Underweight (<18.5) kg/m^2 | Participants | 4 |
| Body Mass Index: Normal (18.5-<25) kg/m^2 | Participants | 47 |
| Body Mass Index: Overweight (25-<30) kg/m^2 | Participants | 46 |
| Body Mass Index: Obese (30 & greater) kg/m^2 | Participants | 32 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS), measured over Baseline and 3 months post study procedure.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Change in rTNSS score from baseline |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean change in reflective Total Nasal Symptoms Score, or rTNSS, between baseline and three months after the study procedure. The questionnaire assesses four symptoms: nasal congestion, runny nose, nasal itching, and sneezing. Each symptom is rated from 0, no symptoms, to 3, severe symptoms, and the symptom scores are summed. The total score ranges from 0-12. A lower total score indicates fewer symptoms, while a higher score indicates more symptoms.
A mean change summarizes the average difference between participants’ baseline and follow-up scores. This is useful for describing the group’s overall symptom-score movement over the specified interval. It does not show how much individual participants varied, and a group mean alone cannot describe the full distribution of responses. The registry record specifies a 95% confidence interval as the measure of dispersion, but the estimate and interval are not reported in the registry record.
General interpretation: the direction and size of a mean change need to be read alongside the score definition, the confidence interval, and the study design. Because this study has no control group, a baseline-to-follow-up change cannot by itself distinguish a procedure-associated change from changes that might occur over time or through other influences. The registry record does not report a numerical primary endpoint result or further details about how the change was calculated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clearly timed primary outcome: mean change in rTNSS from baseline to three months after the procedure. However, it does not report the numerical mean change or its 95% confidence interval. Without those values, the magnitude, direction, and precision of the primary endpoint cannot be assessed from the registry record. The record also lists no analyses, so no primary endpoint analysis result or p-value is available there.
The absence of a numerical endpoint result should not be read as evidence that the score did not change, nor as evidence that it did change. It means that the relevant estimate is not reported in the registry record. The questionnaire’s scoring direction is specified: lower scores indicate fewer symptoms and higher scores indicate more symptoms. But without the observed mean change and a clearly described change-score convention, the direction of the group’s reported movement cannot be established from this record.
The study’s single-group design is important when interpreting any within-participant change. A baseline-to-follow-up comparison can describe what happened to scores in participants assessed at both times. In general, without a concurrent comparator, it cannot determine how much of that change is attributable to the procedure rather than natural symptom variation, changes in other care, expectation, or other influences. This is a limitation of the design, not a numerical conclusion about the result.
The record lists 129 enrolled participants, but enrollment does not establish the number with both baseline and three-month measurements. The number included in the primary endpoint analysis, the handling of missing scores, and the analysis population are not reported in the registry record. These details matter because follow-up availability and analysis choices affect how confidently a group average can be interpreted.
Secondary outcomes include symptom scores at later time points, quality-of-life changes, a responder percentage, and device-related adverse events. Their titles indicate planned outcome domains, but do not provide results. Numerical secondary outcome estimates, definitions of responder status, and analysis details are not reported in the registry record. Results should therefore be described as unavailable in this record, rather than inferred from the outcome names or study status.
The record’s completion status indicates that the study is marked completed, not that every listed outcome has a posted numerical result. The safety figures are reported separately: 0 participants are listed as affected in the serious adverse-event category among 129 at risk, and 0 in the other adverse-event category among 129 at risk. Those entries are bounded to the registry’s recorded categories and do not supply details about event ascertainment or follow-up.
9. Statistical Methods Explained
What does a mean change describe?
General explanation: for a continuous outcome such as rTNSS, a mean change describes the average difference between scores at two specified time points. It reduces a set of participant-level changes to one group-level summary. That summary can be informative, but it does not indicate that every participant changed by the average amount. Participants may have had different starting scores and different follow-up changes.
For this study, the stated interval is baseline to three months after the procedure. The rTNSS is built from ratings of congestion, runny nose, nasal itching, and sneezing. The four item ratings are summed into a total score ranging from 0-12, with lower scores indicating fewer symptoms. The registry record gives the endpoint definition but does not report the observed mean change. The record also does not explain whether the reported change would be calculated as follow-up minus baseline or baseline minus follow-up. That convention is important for interpreting the sign of a change value.
What does a 95% confidence interval communicate?
General explanation: a confidence interval expresses statistical uncertainty around an estimate, under the assumptions of the method used. A narrower interval indicates greater precision than a wider interval, while an interval’s location helps show which values are compatible with the data and method. A confidence interval is not a guarantee that the true value lies within a particular reported interval, and it does not address every source of bias.
The primary endpoint specifies a 95% confidence interval, but neither the interval nor the mean change is reported in the registry record. Consequently, the precision of the primary estimate cannot be assessed. The record also does not report the method used to construct the interval, how missing observations were handled, or whether any adjustment was made for other features of the analysis.
Why does the single-group structure matter?
General explanation: a before-and-after design measures participants at different times but does not provide a separate group’s experience over the same period for comparison. Observed change can reflect the intervention and other influences, including natural variation, changes in other care, expectations, or differences in who contributes follow-up data. A comparator can help distinguish a treatment-associated difference from changes that might also occur without the intervention.
This study is classified as single-group and open label, and no control group is identified in the registry record. Thus, if a change estimate were available, it would describe change in the measured group rather than a controlled treatment contrast. Open-label status means masking is listed as none; additional details about participants’ or assessors’ knowledge of treatment are not reported in the registry record.
How should planning illustrations be read?
General explanation: a sample-size calculation is a planning exercise based on assumptions about an effect to detect, statistical significance, allocation, and a statistical model. It is not an observed result and does not show the probability that a completed study found an effect. Sample sizes based on fractions of an observed effect are illustrative calculations, not a substitute for the trial’s original design justification.
The registry record’s planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. Those assumptions describe a planning illustration; they do not match the registry record’s single-group study structure as a like-for-like randomized comparison. The original sample-size justification and the study’s own design rationale are not reported in the registry record. Since the primary observed effect is also not reported there, planning rows based on fractions of that effect cannot be evaluated from the record alone.
What can the posted analyses establish?
The registry record lists no analyses. It therefore does not provide a statistical model, a test result, or an adjusted estimate for the primary endpoint. General explanation: an analysis description helps readers understand which participants and observations contributed to an estimate, how repeated measurements were handled, and what assumptions underlie the uncertainty calculation. In its absence, the endpoint definition and the listed confidence interval type do not fully specify the analysis.
Enrollment, follow-up, and analysis are distinct concepts. The record lists 129 enrolled, but does not report the number with observed three-month scores or the number included in an endpoint analysis. An enrolled participant is not necessarily a participant with complete follow-up data. The analysis population, missing-data approach, and any sensitivity analyses are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists eight outcome measures: the primary mean change in rTNSS from baseline to three months, along with secondary outcomes covering participant responder percentage, Mini Rhinoconjunctivitis Quality of Life Questionnaire change at three and six months, device-related adverse events, rTNSS scores at three and six months, and rTNSS change from baseline at six months. Listing multiple outcomes raises general questions about how findings across outcomes and time points are interpreted.
General explanation: when many outcomes or comparisons are examined, the chance of at least one apparently notable result can increase if each is considered separately. A statistical plan may specify a primary outcome, an order for testing, or an adjustment approach. The registry record identifies a primary endpoint but does not report a multiplicity strategy or explain whether secondary outcomes were confirmatory or descriptive. It also lists no analyses, and numerical results for the primary endpoint are not reported in the registry record.
Missing-data handling is not reported in the registry record. The record gives 129 enrolled, but does not state how many participants completed each follow-up measure, how absent scores were treated, or whether analyses used all available observations or a defined subset. The analysis population and any sensitivity analyses are also not reported in the registry record.
These omissions limit assessment of how robust any outcome estimate would be to incomplete follow-up or choices among analyses. They do not establish that data were missing or that a particular method was used. The registry record does not report those details.
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 |
|---|---|---|---|
| Treatment Arm | 0 | 129 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment Arm | 0 of 129 |
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 |
|---|---|
| Treatment Arm | 0 of 129 |
The registry record lists 129 participants at risk in the treatment arm for the serious adverse-event category and 129 at risk in the other adverse-event category. It records 0 affected in each category and 0 deaths. No serious adverse-event terms are listed.
These figures describe the counts recorded in the registry categories; they should not be interpreted as proof that no adverse events of any kind occurred. The record’s numerical entries do not provide event descriptions, severity details beyond the serious category, timing, duration, or a fuller account of how events were collected and attributed. The listed 0 in the other category is also limited to that recorded category and does not replace a detailed safety report.
General explanation: safety counts are most interpretable when the population at risk, follow-up period, event definitions, and ascertainment methods are clear. The registry record identifies the at-risk count but does not report those additional details. The secondary outcome list includes device-related adverse events, but a numerical result for that outcome is not reported in the registry record.
The figures are specific to this study record and its enrolled treatment group. They do not permit comparison with another treatment or population, because no comparator group is identified.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a prospective, open-label, multicenter, single-group study evaluated the RhinAer procedure in participants with chronic rhinitis. It identifies the primary measure as mean change in rTNSS from baseline to three months and describes how the symptom score is constructed. It also lists 129 enrolled participants and marks the study completed.
Those details describe the study’s question and structure, but they are not a numerical answer to the primary question. The mean change and its 95% confidence interval are not reported in the registry record. No primary endpoint analysis is listed. It is therefore not possible to determine from this record how large the observed average change was, how precise it was, or whether it moved toward higher or lower scores.
Even if a within-group change estimate were available, its interpretation would be limited by the single-group design. General explanation: a before-and-after result describes change over time among those measured. Without a concurrent comparator, it cannot separate the procedure’s contribution from other influences on symptoms or follow-up. The record identifies no randomized or like-for-like control comparison.
The outcome list includes additional symptom, quality-of-life, responder, and safety measures, but outcome titles alone are not results. Numerical results and analysis details for these measures are not reported in the registry record. Likewise, the listed safety figures document 0 affected in each of the serious and other adverse-event categories among 129 at risk, but do not supply a detailed account of event collection or follow-up.
In general, interpreting clinical trial evidence requires both the estimates and information about who contributed data, how outcomes were analyzed, and how uncertainty was quantified. Several of these details are not reported in the registry record. The record supports a description of the study design and planned outcome measures, but does not support a numerical conclusion about the primary endpoint.
13. Why This Trial Matters Statistically
This trial is statistically notable for the contrast between a clearly specified primary measure and the absence of a posted numerical primary result in the registry record. The endpoint identifies the score, the baseline comparison, and the three-month follow-up time. Those details make the intended outcome understandable, but without the mean change and confidence interval, the size and precision of the observed change cannot be evaluated.
The single-group structure also makes the comparison question important. The primary endpoint is a change over time within the treatment group, not a randomized comparison between groups. General explanation: within-group changes and between-group treatment differences answer different questions. A change from baseline can describe a trajectory, while a controlled contrast helps assess whether that trajectory differs from what would have occurred under another condition.
The study also lists several secondary outcomes across symptoms, quality of life, responder status, and safety. This breadth underscores why analysis details matter: readers need to know how outcomes were prioritized, how multiple outcomes were handled, and which participants contributed to each estimate. Those analysis details are not reported in the registry record.
The record still contributes useful information about design, follow-up timing, the questionnaire’s scoring, and the recorded safety counts. It also makes clear that enrollment is not the same as a reported analysis population. Without the numerical endpoint and methods of analysis, however, the registry record cannot show the observed primary result or its statistical uncertainty.
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 statistical interpretation is that the registry record does not report the mean change in rTNSS or its 95% confidence interval. It also lists no analyses. As a result, the primary endpoint’s magnitude, direction, and precision cannot be assessed from this record.
The study is single-group and open label, with no like-for-like control comparison identified. Any within-group change, if reported elsewhere, would not by itself separate procedure-associated change from other influences over time. The record does not report a comparator or masking.
The record lists 129 enrolled, but does not state how many participants contributed baseline and three-month scores, how many completed later assessments, or which analysis population was used. Missing-data procedures and sensitivity analyses are not reported in the registry record. These omissions limit assessment of possible effects of incomplete follow-up or analysis choices.
Although eight outcome measures are listed, the record does not report a multiplicity strategy or distinguish confirmatory from descriptive secondary analyses. Responder criteria and numerical secondary outcome results are not reported in the registry record. The procedural details beyond the device and clinic setting are also limited, and details on outcome assessment and adverse-event ascertainment are not reported.
The record marks the study completed, but that status does not supply missing outcome estimates or analysis details. The safety entries list 0 affected in both recorded adverse-event categories among 129 at risk and 0 deaths; event definitions and collection details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF) — NCT04614324.
- Registry record last updated 2026-11-02; status last verified 2026-10.
- Results first posted 2024-08-21.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, prospective, open-label, multicenter, single-group post-market study of the RhinAer procedure for chronic rhinitis. It lists 129 participants enrolled. The primary endpoint is mean change in rTNSS from baseline to three months after the procedure, with a 95% confidence interval specified. The rTNSS sums ratings of four nasal symptoms, ranges from 0-12, and uses lower scores to indicate fewer symptoms.
The record lists secondary outcomes in symptom scores, quality of life, responder status, and device-related adverse events. It lists no analyses, and the primary endpoint estimate and confidence interval are not reported in the registry record. The safety entries record 0 affected in the serious and other adverse-event categories among 129 at risk, with 0 deaths. The single-group design does not provide a control-group comparison.