Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

Study Overview
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Brief Summary
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This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction

Detailed Description
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This is a non-significant risk, prospective, non-randomized study to evaluate subjective and objective measures of nasal obstruction both before and after treatment with the Vivaer Stylus. The Stylus is used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Official Title
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A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus

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: Complaints of nasal obstruction for at least 1 year Failed maximum medical therapy (4-6 weeks of steroids) Nasal Obstruction Symptom Evaluation (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 during 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 Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session Known or suspected to be pregnant, or is lactating Other medical conditions which in the opinion of the investigator could predispose the subject to poor wound healing or increased surgical risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 Treatment<br>Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area | Device: Vivaer Stylus<br>* Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area<br>* Other names: Aerin Medical Stylus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NOSE Score | Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 90 days post-study procedure. Improvement (90 day score - baseline score) is signified by a negative value. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity. | Baseline, 90 days | 
| Change in VAS of Nasal Obstruction | Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject from baseline to 90 days post-study procedure. Improvement (90-day score - baseline score) is signified by a negative value. The visual-analog scale (VAS) of nasal obstruction is presented to the subject as a 10cm line anchored on each end by verbal descriptors: 0 = No Obstruction and 10 = Completely Obstructed. The subject is asked to place a vertical mark on the line to show the level of nasal obstruction they feel. The distance between 0 and the vertical mark made by the subject is measured and the results is expressed in centimeters. Higher scores indicate more severe obstruction. | Baseline, 90 days | 

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