Clinical Trial

Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

Study acronym: BREATHE AI
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-04.
Trial Details
NCT Number NCT07574918
Lead Sponsor Aerin Medical
Conditions Nasal Airway Obstruction
Enrollment 30 participants
Start Date 2026-07
Primary Completion 2027-03 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-14