Adults 18 to 85, any sex, with Nasal Airway Obstruction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder RatePrimary· 3 months visit following the study procedure.
The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses.
Group
Value
95% CI
Active Treatment Arm: Vivaer Procedure
88.3
79.2 – 93.7
Control Arm: Sham Control Procedure
42.5
28.5 – 57.8
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 MonthsSecondary· Change from Baseline to 3 months following the study procedure.
The NOSE Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction.
This study will measure the mean change in NOSE Scale from baseline to 3 months after procedure.
Group
Value
95% CI
Vivaer Procedure
-42.3
-46.6 – -37.1
Sham Control Procedure
-16.8
-26.3 – -7.2
Percentage of Participants With Treatment Related Events (Safety) - Through 3 MonthsSecondary· At or following the study procedure up to to 3 months.
Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, seriousness, intensity, duration and outcome will be documented.
Group
Value
95% CI
Vivaer Procedure
1
Sham Control Procedure
0
Vivaer Procedure
1
Sham Control Procedure
0
Vivaer Procedure
0
Sham Control Procedure
1
Vivaer Procedure
75
Sham Control Procedure
38
NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE ScoreSecondary· 3 Month
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
Measurement is # improvement in NOSE Scale score from baseline, the lower the score the les
Group
Value
95% CI
Combined Active Treatment (Vivaer Procedure)
53.6
NOSE Scale Score - 3 Month AverageSecondary· 3 Month
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
These data represents the NOSE Scale average score from baseline at 3 months
Group
Value
95% CI
Combined Active Treatment (Vivaer Procedure)
35.4
30.8 – 40.1
NOSE Scale Score - 6 Month AverageSecondary· 6 Month
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
These data represents the NOSE Scale average score from baseline at 6 months
Group
Value
95% CI
Combined Active Treatment (Vivaer Procedure)
33.2
28.4 – 37.9
NOSE Scale Score - 12 Month AverageSecondary· 12 Month
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
These data represents the NOSE Scale average score from baseline at 12 months
Group
Value
95% CI
Combined Active Treatment (Vivaer Procedure)
31.4
26.3 – 36.5
NOSE Scale Score - 24 Month AverageSecondary· 24 Month
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
These data represents the NOSE Scale average score from baseline at 12 months
Group
Value
95% CI
Combined Active Treatment (Vivaer Procedure)
-41.70
-48.80 – -34.60
NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE ScoreSecondary· 6 Month
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
Measurement is # improvement in NOSE Scale score from baseline
These data represents percen
Group
Value
95% CI
Combined Active Treatment (Vivaer Procedure)
56.6
NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE ScoreSecondary· 12 Month
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
These data represents percent improvement in NOSE Scale score from baseline at 12 months
Group
Value
95% CI
Combined Active Treatment (Vivaer Procedure)
58.8
NOSE Scale Score -24 Month Responder Rate Improvement in NOSE ScoreSecondary· 24 Month
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
These data represents percent improvement in NOSE Scale score from baseline at 12 months
The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.
The mean change in Epworth S
Group
Value
95% CI
Combined Active Treatment (Vivaer Procedure)
6.5
5.6 – 7.5
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aerin Medical
Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04549545.