CompletedNot Applicable

Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction

United States122 participantsStarted 2020-02-07

Plain-language summary

Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18 or older
✓. Willing and able to provide informed consent
✓. Willing and able to comply with the study protocol
✓. Seeking treatment for nasal obstruction
✓. NOSE score of ≥ 60 at Baseline
✓. 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):

✕. Prior surgical treatment of the nasal valve
✕. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
✕. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
✕. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months

Timeframe: 3 Month

NCT IDNCT04277507

SponsorAerin Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-31

Results submitted2023-01-30