Nasal Airway Obstruction
Conditions
Keywords
VivAer, Nasal airway obstruction, Aerin Medical
Brief 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.
Interventions
DEVICEVivAer Stylus
Bipolar radiofrequency energy delivered to the lateral nasal wall at the upper lateral cartilage using the VivAer® Stylus and Aerin Console at device default settings (temperature 60°C, power 4 watts, treatment time 18 seconds, cooling time 12 seconds) to remodel submucosal tissue, including cartilage, in the internal nasal valve area.
Sponsors
Aerin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in nasal valve angle and cross-sectional area | Baseline to 3- and 6-months post-procedure. | Quantitatively assess anatomic improvement of the internal nasal valve (INV) and nasal airway following VivAer treatment using VISIONAIR™ analysis. |
Contacts
CONTACTNeda Haque
CONTACTTien Dang
Outcome results
None listed