Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
Sponsored by Aerin Medical
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Age 18 or older
2. Willing and able to provide informed consent
3. Willing and able to comply with the study protocol
4. Seeking treatment for nasal obstruction
5. NOSE score of ≥ 60 at Baseline
6. Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):
Exclusion Criteria
1. Prior surgical treatment of the nasal valve
2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.