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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 Short-Form (SF-12) Health Survey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VivAer Treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VivAer Stylus | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nasal valve angle and cross-sectional area | Quantitatively assess anatomic improvement of the internal nasal valve (INV) and nasal airway following VivAer treatment using VISIONAIRâ„¢ analysis. | Baseline to 3- and 6-months post-procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neda Haque | Contact | (408) 784-9452 | nhaque@aerinmedical.com | |
| Tien Dang | Contact | tdang@aerinmedical.com |
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This is a small post-market study with a limited sample size, proprietary devices (VivAer® and VISIONAIR™), and no stated plan in the protocol to share individual participant data with outside researchers. Sharing IPD is generally more relevant for larger clinical trials.
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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|
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |