Trial Outcomes & Findings for Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study (NCT NCT04549545)
NCT ID: NCT04549545
Last Updated: 2025-08-28
Results Overview
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.
COMPLETED
NA
119 participants
3 months visit following the study procedure.
2025-08-28
Participant Flow
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.
There was no wash out or run in for this study
Participant milestones
| Measure |
Active Treatment Arm: Vivaer Procedure Only
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure First, Optional Crossover to Vivaer Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Initial Period
STARTED
|
78
|
41
|
|
Initial Period
COMPLETED
|
68
|
31
|
|
Initial Period
NOT COMPLETED
|
10
|
10
|
|
Crossover Period
STARTED
|
0
|
31
|
|
Crossover Period
COMPLETED
|
0
|
20
|
|
Crossover Period
NOT COMPLETED
|
0
|
11
|
Reasons for withdrawal
| Measure |
Active Treatment Arm: Vivaer Procedure Only
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure First, Optional Crossover to Vivaer Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Initial Period
Withdrawal by Subject
|
4
|
0
|
|
Initial Period
Additional ENT Procedure
|
3
|
0
|
|
Initial Period
Lost to Follow-up
|
3
|
1
|
|
Initial Period
Ineligible for Crossover and Exited as study complete
|
0
|
9
|
|
Crossover Period
Additional ENT Procedure
|
0
|
6
|
|
Crossover Period
Lost to Follow-up
|
0
|
1
|
|
Crossover Period
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study
Baseline characteristics by cohort
| Measure |
Active Treament Arm - Vivaer Procedure Only
n=78 Participants
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).
Vivaer ARC Stylus: 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.
|
Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure
n=41 Participants
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).
Sham: 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).
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
47 participants
n=5 Participants
|
25 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
30 participants
n=5 Participants
|
15 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
69 participants
n=5 Participants
|
36 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Declined Choice
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Baseline NOSE Scale Score
|
76.7 Average Score
STANDARD_DEVIATION 12.6 • n=5 Participants
|
78.8 Average Score
STANDARD_DEVIATION 14.3 • n=7 Participants
|
77.4 Average Score
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Ease-of-breathing VAS Score
|
59.3 score
STANDARD_DEVIATION 21.6 • n=5 Participants
|
61.8 score
STANDARD_DEVIATION 18.4 • n=7 Participants
|
60.1 score
STANDARD_DEVIATION 20.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months visit following the study procedure.Population: The percentage of patients designated responders, defined as 20% or greater improvement (decrease) in Nasal Obstruction Symptom Evaluation (NOSE)Scale score or 1 or greater NOSE Scale severity category improvement from baseline. Error bars indicate 95% CIs.
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.
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=77 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
n=39 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
|
88.3 percentage of participants
Interval 79.2 to 93.7
|
42.5 percentage of participants
Interval 28.5 to 57.8
|
SECONDARY outcome
Timeframe: Change from Baseline to 3 months following the study procedure.Population: At baseline, all patients were classified as having extreme or severe obstruction, based on the NOSE-scale severity classification system. This outcome measure shows the difference in overall score between baseline and 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.
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=77 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
n=39 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months
|
-42.3 score on a scale
Interval -46.6 to -37.1
|
-16.8 score on a scale
Interval -26.3 to -7.2
|
SECONDARY outcome
Timeframe: At or following the study procedure up to to 3 months.Population: Adverse events considered at least possibly related to the device and/or procedure
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.
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=77 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
n=39 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
Vasovagal Reaction
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
Intermittent Nose Bleed with Mucous
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
Headache
|
0 Participants
|
1 Participants
|
|
Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
No Safety Issue
|
75 Participants
|
38 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 MonthPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=107 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score
|
53.6 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 MonthPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=107 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
NOSE Scale Score - 3 Month Average
|
35.4 score on a scale
Interval 30.8 to 40.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=100 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
NOSE Scale Score - 6 Month Average
|
33.2 score on a scale
Interval 28.4 to 37.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=88 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
NOSE Scale Score - 12 Month Average
|
31.4 score on a scale
Interval 26.3 to 36.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 MonthPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=73 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
NOSE Scale Score - 24 Month Average
|
-41.70 score on a scale
Interval -48.8 to -34.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthThe 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
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=100 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE Score
|
56.6 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=88 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE Score
|
58.8 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 MonthPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=73 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
NOSE Scale Score -24 Month Responder Rate Improvement in NOSE Score
|
90.40 score on a scale
Interval 81.5 to 95.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 MonthsPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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.
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=107 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Epworth Sleepiness Scale - 3 Month
|
6.5 score on a scale
Interval 5.6 to 7.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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.
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=100 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Epworth Sleepiness Scale - 6 Month
|
6.2 score on a scale
Interval 5.3 to 7.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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.
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=88 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Epworth Sleepiness Scale - 12 Months
|
5.5 score on a scale
Interval 4.6 to 6.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 MonthsPopulation: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
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.
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=73 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
|
|---|---|---|
|
Epworth Sleepiness Scale - 24 Months
|
5.4 score on a scale
Interval 4.5 to 6.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsMedications tracked during the trial were antihistamines, decongestants, leukotriene inhibitors, intranasal steroids, anticholinergics, and immunotherapy. Use of nasal strips/cones was also tracked.
Outcome measures
| Measure |
Active Treatment Arm: Vivaer Procedure
n=88 Participants
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Control Arm: Sham Control Procedure
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
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).
Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.
Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.
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|---|---|---|
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Concomitant Medication and Mechanical Nasal Aid Analysis
No Change in Medication/Mechanical Aid Use
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27 percent
|
—
|
|
Concomitant Medication and Mechanical Nasal Aid Analysis
Decrease/Stopped Use in 1 Class of Medication/Mechanical Aid Use
|
67 percent
|
—
|
|
Concomitant Medication and Mechanical Nasal Aid Analysis
Increase/Started 1 class of Medication/Mechanical Aid Use
|
8 percent
|
—
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Adverse Events
Vivaer Procedure
Sham Control Procedure
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vivaer Procedure
n=108 participants at risk
A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)
Subjects randomized to the Active Treatment will receive the Vivaer procedure.
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).
Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Active treatment participants (Vivaer procedure) will have an extended follow-up with evaluations conducted in-office at 6 months (26 weeks) and remotely at 12 months (52 weeks) and 24 months (104 weeks).
|
Sham Control Procedure
n=39 participants at risk
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).
Sham: 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).
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|---|---|---|
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Injury, poisoning and procedural complications
Nasal Bleeding
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1.9%
2/108 • Number of events 2 • 1 year
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0.00%
0/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
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2.8%
3/108 • Number of events 3 • 1 year
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0.00%
0/39 • 1 year
|
|
Nervous system disorders
Headache
|
0.93%
1/108 • Number of events 1 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Nervous system disorders
Vasovagal reaction
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0.93%
1/108 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place