Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

Not Applicable

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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):
1. Use of external nasal dilator strips (e.g., Breathe Right Strips)
2. Q-Tip test (manual intranasal lateralization)
3. Use of nasal stents
4. 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

Primary Outcome Measures

Name	Time	Method
Change in NOSE Score	Baseline, 90 days	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.
Change in VAS of Nasal Obstruction	Baseline, 90 days	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): The Ohio State Eye and Ear Institute
🇺🇸
Columbus, Ohio, United States
The Ohio State Eye and Ear Institute
🇺🇸Columbus, Ohio, United States