Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

Starting soon · Not applicable

Conditions studied: Nasal Airway Obstruction

In brief

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.

Key facts

Study ID

NCT07574918

Run by

Aerin Medical

People needed

30

Starts

2026-07-01

Expected to finish

2027-05-01

Last updated by the study team

2026-05-14

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 22 to 85 years old (inclusively).
• Willing and able to provide consent.
• Willing and able to comply with the patient-specific requirements and follow-up schedule outlined in the study protocol.
• Has a NOSE Score of ≥ 55.
• Has a documented diagnosis of NAO with NVC (static or dynamic) as the primary driver of NAO symptoms.
• Has a documented positive Modified Cottle Maneuver (using curette or equivalent to perform maneuver and evaluate nasal valve function).

You may not qualify if…

• Has had rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic surgery (FESS) within the preceding 3 months.
• Has uncontrolled chronic rhinitis as a contributor to nasal obstruction symptoms.
• Has a complex nasal anatomy (e.g., anatomical deformity) or a history of significant nasal trauma that is a potential contributor to nasal obstruction symptoms.
• Has any intranasal conditions that preclude adequate visualization of the nasal valve area.
• Has a medical condition(s) that may impair normal healing processes.
• Any adjunctive surgical or other nasal procedure (e.g., concha bullosa resection, inferior turbinate out fracture, septoplasty, etc.) on the same day or planned within 6 months of the study procedure.
• Has current or recent (within 30 days prior to screening) exposure to oral systemic corticosteroids or is expected to require oral corticosteroid therapy during the course of the study.
• Has nasal polyps, or a history of nasal polyps requiring medical or surgical treatment within the past 12 months.

Full record on ClinicalTrials.gov

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