An interventional study of VivAer Stylus in Nasal Airway Obstruction, sponsored by Aerin Medical. Not yet recruiting. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Aerin Medical · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Device: VivAer Stylus
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.
No study locations are listed for this record.
Plan to share: No — This is a small post-market study with a limited sample size, proprietary devices (VivAer® and VISIONAIR™), and no stated plan in the protocol to share individual participant data with outside researchers. Sharing IPD is generally more relevant for larger clinical trials.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Aerin Medical