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 2026-11-02.
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.
173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.
This study's enrollment of 70 is close to 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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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 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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No data collected will be shared with other researchers participating in the study.
Ran from Sep 2021 to primary completion in Apr 2022, 7 months.
Results were first posted in Aug 2024, 2 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 7 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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