Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction

Study Overview
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Brief Summary
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Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

Detailed Description
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Prospective, Multicenter, Non-randomized Study of the Aerin Medical Vivaer® ARC Stylus for Nasal Airway Obstruction to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Official Title
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A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)

Conditions
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Nasal Obstruction

Intervention / Treatment
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* Device: Vivaer Stylus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Willing and able to provide informed consent Willing and able to comply with the study protocol Seeking treatment for nasal obstruction NOSE score of ≥ 60 at Baseline Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam): Use of external nasal dilator strips (e.g., Breathe Right Strips) Q-Tip test (manual intranasal lateralization) Use of nasal stents Cottle Maneuver (manual lateral retraction of the cheek) Exclusion Criteria: Prior surgical treatment of the nasal valve Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vivaer Stylus<br>Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area | Device: Vivaer Stylus<br>* Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area<br>* Other names: Aerin Medical Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months | Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms. | 3 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal valve, Nasal airway obstruction