Nasal Airway Changes After VivAer Treatment Measured with AI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults aged 22 to 85 with nasal obstruction due to nasal valve dysfunction who will undergo the VivAer procedure. Endoscopic images of the nasal airway are taken before treatment and at 3 and 6 months afterward and analyzed with the VISIONAIR AI system to quantify changes. Participants will complete symptom and quality-of-life surveys at each visit, including the NOSE scale, STOP-BANG sleep score, and SF-12. The study aims to determine if measurable airway changes and improvements in symptoms correlate with AI-analyzed imaging after treatment. No comparison group is described.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Has had rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic surgery (FESS) within the preceding 3 months.
2. Has uncontrolled chronic rhinitis as a contributor to nasal obstruction symptoms.
3. 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.
4. Has any intranasal conditions that preclude adequate visualization of the nasal valve area.
5. Has a medical condition(s) that may impair normal healing processes.
6. 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.
7. 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.
8. Has nasal polyps, or a history of nasal polyps requiring medical or surgical treatment within the past 12 months.

Where it's running

• ENT & Allergy of Delaware
  Newark, Delaware, United States Recruiting

Study contacts

• Study coordinator: Tien Dang, MS
• Email: tdang@aerinmedical.com
• Phone: 6692566596

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.