The goal of this clinical trial is to measure changes in the nasal airway after treatment with the VivAer® procedure in adults aged 22 to 85 with nasal airway obstruction caused by nasal valve dysfunction. The main questions it aims to answer are: Are there measurable changes in the nasal airway and airflow after treatment with the VivAer procedure? Participants will: Undergo the VivAer procedure, which uses radiofrequency energy to remodel tissue in the nasal valve area. Have endoscopic images of their nasal airway taken before treatment and at follow-up visits at 3 and 6 months after treatment, which will be analyzed using the VISIONAIR™ AI System. They will complete symptom and quality of life surveys at each visit, including the Nasal Obstruction Symptom Evaluation (NOSE) Scale, the STOP-BANG Sleep Score, and the Short-Form (SF-12) Health Survey.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Bipolar radiofrequency energy delivered to the lateral nasal wall at the upper lateral cartilage using the VivAer® Stylus and Aerin Console at device default settings (temperature 60°C, power 4 watts, treatment time 18 seconds, cooling time 12 seconds) to remodel submucosal tissue, including cartilage, in the internal nasal valve area.
Change in nasal valve angle and cross-sectional area
Quantitatively assess anatomic improvement of the internal nasal valve (INV) and nasal airway following VivAer treatment using VISIONAIR™ analysis.
Time frame: Baseline to 3- and 6-months post-procedure.
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