Clinical Trial TitleThe Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)
National Clinical Trial Number:NCT05099263
Clinical Trial Protocol Description:
Prospective, open-label, multi-center, single arm study of the Aerin Medical Vivaer ARC Stylus to treat Septal Swell Bodies (SSB) to improve symptoms in adults diagnosed with nasal obstruction attributed to SSB.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Age 22 to 85 years (inclusively).
- Baseline NOSE score ≥ 55.
- Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%.
You will be excluded from the study if any of the following criteria apply to you:
- Rhinoplasty, septoplasty, inferior turbinate (IT) reduction or other surgical nasal procedures within the preceding 6 months.
- Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps or ptotic nose tip believed to be the primary contributor to the participant's nasal obstruction symptoms and warranting surgical intervention.
- Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
This is a partial list of inclusion and exclusion criteria.