An interventional study of Vivaer Arc Stylus in Nasal Obstruction, sponsored by Aerin Medical. Completed at 9 sites in United States. Open to participants aged 22 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Aerin Medical · Not applicable, Interventional, and Treatment
Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).
Prospective, Open-Label, Multicenter, Single Arm Study of the Aerin Medical Vivaer ARC Stylus to treat Septal Swell Bodies (SSB) to improve symptoms in adults diagnosed with nasal obstruction attributed to SSB.
Exclusion Criteria:
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 will undergo bilateral treatment of the nasal airway in a single study procedure session. Each side of the nose will be treated as follows: • Two (2) to six (6) nonoverlapping applications of RF energy are performed at the SSB per nostril. The default treatment settings will be used for the study: 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 (36 months).
Device: 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 airway in a single study session.
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change
The primary endpoint is improvement in self-reported Nasal Obstruction Symptom Evaluation (NOSE) Scale score from baseline recorded at the screening evaluation to 13 weeks after the procedure. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of participants treated for nasal obstruction.43 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 mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE Scale survey.
Time frame: 3 months (13 weeks) visit following screening
Responder Percent
Responder percent: A responder is defined as at least 1 NOSE Scale class improvement or an improvement (decrease) in NOSE Scale score of 20% or more from baseline to 13 weeks after the procedure (eg, going from a score in the severe range (55-75) at preprocedure to a score in the moderate range (30-50) at the 3-month evaluation), or an improvement (decrease) in NOSE Scale score of 20% or more from screening at the 3-month evaluation.
Time frame: 3 months (13 weeks) visit following baseline
Number of Participants With Device Related Adverse Events
Frequency of device-related and procedure-related serious adverse events, including frequency of septal perforation during the procedure, through the 3-month evaluation.
Time frame: At or following the study procedure up to 3 months.
Participants were recruited based on physician referral at 9 academic medical centers and clinics between August 25, 2021 and April 28, 2022. The First Participant enrolled on September 14, 2021 and the last participant enrolled on April 28, 2022.
| Milestone | Vivaer Procedure |
|---|---|
| Started | 70 |
| 3-month | 68 |
| 6-month | 65 |
| 12-month | 62 |
| Completed | 0 |
| Not completed | 70 |
The primary endpoint is improvement in self-reported Nasal Obstruction Symptom Evaluation (NOSE) Scale score from baseline recorded at the screening evaluation to 13 weeks after the procedure. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of participants treated for nasal obstruction.43 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 mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE Scale survey.
| score on a scale | Vivaer Procedure |
|---|---|
| Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change | -45.3 ± 21.4 |
Responder percent: A responder is defined as at least 1 NOSE Scale class improvement or an improvement (decrease) in NOSE Scale score of 20% or more from baseline to 13 weeks after the procedure (eg, going from a score in the severe range (55-75) at preprocedure to a score in the moderate range (30-50) at the 3-month evaluation), or an improvement (decrease) in NOSE Scale score of 20% or more from screening at the 3-month evaluation.
| percentage of responders | Vivaer Procedure |
|---|---|
| Responder Percent | 95.7 |
Frequency of device-related and procedure-related serious adverse events, including frequency of septal perforation during the procedure, through the 3-month evaluation.
| Participants | Vivaer Procedure |
|---|---|
| Visual acuity change (transient) | 1 |
| Nasal scarring at 3M | 2 |
| Nasal bleeding at 1M | 1 |
| Nasal Discharge | 2 |
| Headache | 1 |
| Nasal Congestion/Obstruction | 1 |
| Vasovagal reaction | 1 |
| No Device or Procedure related Issues | 60 |
Collected over 2 years and 7.5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vivaer Procedure | 0/69 (0%) | 0/69 (0%) | 9/69 (13%) |
| Event | Vivaer Procedure |
|---|---|
| Nasal Scarring at 3MSkin and subcutaneous tissue disorders | 2/69 |
| Nasal DischargeSkin and subcutaneous tissue disorders | 2/69 |
| Visual Acuity Change (Transient)Eye disorders | 1/69 |
| Nasal Bleeding at 1MBlood and lymphatic system disorders | 1/69 |
| HeadacheNervous system disorders | 1/69 |
| Nasal Congestion/ObstructionRespiratory, thoracic and mediastinal disorders | 1/69 |
| Vasovagal ReactionCardiac disorders | 1/69 |
| Age, Categorical(Participants) | Single Arm - Vivaer Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 57 |
| >=65 years | 13 |
| Sex: Female, Male(Participants) | Single Arm - Vivaer Treatment |
|---|---|
| Female | 34 |
| Male | 36 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm - Vivaer Treatment |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 60 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Arm - Vivaer Treatment |
|---|---|
| United States | 70 |
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Plan to share: No — No data collected will be shared with other researchers participating in the study.
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