An interventional study of Vivaer ARC Stylus and Sham in Nasal Airway Obstruction, sponsored by Aerin Medical. Completed at 12 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Aerin Medical · Not applicable, Interventional, and Treatment
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).
The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.
173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.
This study's enrollment of 119 is above the median of 70 across 139 interventional studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →Aerin Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session. Each side of the nose will be treated with up to four (4) non-overlapping applications of RF energy at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Treatment settings to be used are: temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (24 months).
Device: Vivaer ARC Stylus
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Device: Sham
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
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.
Time frame: 3 months visit following the study procedure.
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months
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.
Time frame: Change from Baseline to 3 months following the study procedure.
Percentage of Participants With Treatment Related Events (Safety) - Through 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.
Time frame: At or following the study procedure up to to 3 months.
NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score
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 less obstruction or a change to lower score indicates improvement in nasal airway obstruction. These data represents percent improvement in NOSE Scale score from baseline at 3 months
Time frame: 3 Month
NOSE Scale Score - 3 Month Average
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
Time frame: 3 Month
NOSE Scale Score - 6 Month Average
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
Time frame: 6 Month
NOSE Scale Score - 12 Month Average
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
Time frame: 12 Month
NOSE Scale Score - 24 Month Average
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
Time frame: 24 Month
NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE Score
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 percent improvement in NOSE Scale score from baseline at 6 months
Time frame: 6 Month
NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE Score
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
Time frame: 12 Month
NOSE Scale Score -24 Month Responder Rate Improvement in NOSE Score
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
Time frame: 24 Month
Epworth Sleepiness Scale - 3 Month
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 Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
Time frame: 3 Months
Epworth Sleepiness Scale - 6 Month
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 Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
Time frame: 6 Months
Epworth Sleepiness Scale - 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 Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
Time frame: 12 Months
Epworth Sleepiness Scale - 24 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 Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
Time frame: 24 Months
Concomitant Medication and Mechanical Nasal Aid Analysis
Medications tracked during the trial were antihistamines, decongestants, leukotriene inhibitors, intranasal steroids, anticholinergics, and immunotherapy. Use of nasal strips/cones was also tracked.
Time frame: 12 Months
Particpants were recruited based on physican referral at 16 academic medical centers and clinics between August 12,2020 and December 28, 2020. The First Participant enrolled on August 12, 2020 and the last participant enrolled on December 28, 2020.
| Milestone | Active Treatment Arm: Vivaer Procedure Only | Control Arm: Sham Control Procedure First, Optional Crossover to Vivaer Procedure |
|---|---|---|
| Started | 78 | 41 |
| Completed | 68 | 31 |
| Not completed | 10 | 10 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Additional ent procedure | 3 | 0 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Ineligible for crossover and exited as study complete | 0 | 9 |
| Milestone | Active Treatment Arm: Vivaer Procedure Only | Control Arm: Sham Control Procedure First, Optional Crossover to Vivaer Procedure |
|---|---|---|
| Started | 0 | 31 |
| Completed | 0 | 20 |
| Not completed | 0 | 11 |
| Withdrew: Additional ent procedure | 0 | 6 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 4 |
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.
| percentage of participants | Active Treatment Arm: Vivaer Procedure | Control Arm: Sham Control Procedure |
|---|---|---|
| Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate | 88.3 (79.2 to 93.7) | 42.5 (28.5 to 57.8) |
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.
| score on a scale | Vivaer Procedure | Sham Control Procedure |
|---|---|---|
| Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months | -42.3 (-46.6 to -37.1) | -16.8 (-26.3 to -7.2) |
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.
| Participants | Vivaer Procedure | Sham Control Procedure |
|---|---|---|
| Vasovagal Reaction | 1 | 0 |
| Intermittent Nose Bleed with Mucous | 1 | 0 |
| Headache | 0 | 1 |
| No Safety Issue | 75 | 38 |
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 less obstruction or a change to lower score indicates improvement in nasal airway obstruction. These data represents percent improvement in NOSE Scale score from baseline at 3 months
| percentage of participants | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score | 53.6 |
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
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| NOSE Scale Score - 3 Month Average | 35.4 (30.8 to 40.1) |
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
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| NOSE Scale Score - 6 Month Average | 33.2 (28.4 to 37.9) |
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
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| NOSE Scale Score - 12 Month Average | 31.4 (26.3 to 36.5) |
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
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| NOSE Scale Score - 24 Month Average | -41.70 (-48.80 to -34.60) |
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 percent improvement in NOSE Scale score from baseline at 6 months
| percentage of participants | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE Score | 56.6 |
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
| percentage of participants | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE Score | 58.8 |
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
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| NOSE Scale Score -24 Month Responder Rate Improvement in NOSE Score | 90.40 (81.50 to 95.30) |
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 Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| Epworth Sleepiness Scale - 3 Month | 6.5 (5.6 to 7.5) |
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 Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| Epworth Sleepiness Scale - 6 Month | 6.2 (5.3 to 7.1) |
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 Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| Epworth Sleepiness Scale - 12 Months | 5.5 (4.6 to 6.4) |
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 Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
| score on a scale | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| Epworth Sleepiness Scale - 24 Months | 5.4 (4.5 to 6.4) |
Medications tracked during the trial were antihistamines, decongestants, leukotriene inhibitors, intranasal steroids, anticholinergics, and immunotherapy. Use of nasal strips/cones was also tracked.
| percent | Combined Active Treatment (Vivaer Procedure) |
|---|---|
| No Change in Medication/Mechanical Aid Use | 27 |
| Decrease/Stopped Use in 1 Class of Medication/Mechanical Aid Use | 67 |
| Increase/Started 1 class of Medication/Mechanical Aid Use | 8 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vivaer Procedure | 0/108 (0%) | 0/108 (0%) | 7/108 (6.5%) |
| Sham Control Procedure | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) |
| Event | Vivaer Procedure | Sham Control Procedure |
|---|---|---|
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 3/108 | 0/39 |
| HeadacheNervous system disorders | 1/108 | 1/39 |
| Nasal BleedingInjury, poisoning and procedural complications | 2/108 | 0/39 |
| Vasovagal reactionNervous system disorders | 1/108 | 0/39 |
A total of 119 eligible patients were randomized. Assignment with 78 in the active treatment arm and 41 in the sham-control arm. One patient in the active treatment arm withdrew consent before treatment. One patient in the sham-control arm was lost to follow-up before the 3-month visit (primary endpoint).Therefore, a total of 117 patients (77 active treatment and40 sham control) were included in the analysis of the 3-month primary endpoint.
| Age, Categorical(Participants) | Active Treament Arm - Vivaer Procedure Only | Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 78 | 41 | 119 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active Treament Arm - Vivaer Procedure Only | Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure | Total |
|---|---|---|---|
| Mean | 47.7 ± 12.4 | 50.0 ± 11.2 | 48.5 ± 12.3 |
| Sex/Gender, Customized(participants) | Active Treament Arm - Vivaer Procedure Only | Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure | Total |
|---|---|---|---|
| Female | 47 | 25 | 72 |
| Male | 30 | 15 | 45 |
| Race/Ethnicity, Customized(participants) | Active Treament Arm - Vivaer Procedure Only | Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 1 | 1 | 2 |
| Black or African American | 4 | 2 | 6 |
| White | 69 | 36 | 105 |
| Declined Choice | 2 | 0 | 2 |
| Baseline NOSE Scale Score(Average Score) | Active Treament Arm - Vivaer Procedure Only | Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure | Total |
|---|---|---|---|
| Mean | 76.7 ± 12.6 | 78.8 ± 14.3 | 77.4 ± 13.2 |
| Ease-of-breathing VAS Score(score) | Active Treament Arm - Vivaer Procedure Only | Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure | Total |
|---|---|---|---|
| Median | 59.3 ± 21.6 | 61.8 ± 18.4 | 60.1 ± 20.6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2020 to primary completion in Mar 2021, 6 months.
Results were first posted in Jun 2024, 3 years 3 months after primary completion.
Of 60 interventional studies with no phase under Nasal Obstruction, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aerin Medical