Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis. (NCT07574918) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis.
30 participantsStarted 2026-07
Plain-language 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 VISIONAIRâ„¢ 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 SF-12 Health Survey.
Who can participate
Age range22 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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.
What they're measuring
1
Change in nasal valve angle and cross-sectional area
Timeframe: Baseline to 3- and 6-months post-procedure.
✕. 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.