VivAer Treatment for Nasal Obstruction
(BREATHE AI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults aged 22 to 85 who have significant nasal blockage due to nasal valve dysfunction, confirmed by specific tests. Participants must be able to give consent and follow the study schedule.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- VivAer Stylus
Trial Overview
The study looks at how the VivAer procedure, which uses radiofrequency energy to reshape tissue in the nose, affects airflow and symptoms in people with nasal obstruction. Changes are measured using imaging and symptom surveys over six months.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aerin Medical
Lead Sponsor
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