Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Study Overview
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Brief Summary
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Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.

Detailed Description
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This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when 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, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

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: Seeking treatment for nasal obstruction and willing to undergo an office-based procedure 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 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 twelve (12) months Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms Known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications 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: 22 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<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 |
| --- | --- | --- |
| Improvement in NOSE Score | Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive 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, 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NOSE Responder Rate | Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment. | Baseline, 26 weeks | 
| Percentage of Participants With Treatment-Related Adverse Events (Safety) | Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period. | Baseline through 26 weeks | 

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