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

Completed · Not applicable

Conditions studied: Nasal Obstruction

In brief

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

Key facts

Study ID

NCT04277507

Run by

Aerin Medical

People needed

122

Starts

2020-02-07

Expected to finish

2024-10-11

Last updated by the study team

2025-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• Use of external nasal dilator strips (e.g., Breathe Right Strips)
• Q-Tip test (manual intranasal lateralization)
• Use of nasal stents
• Cottle Maneuver (manual lateral retraction of the cheek)

You may not qualify if…

• 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.

Where it is running

• Alabama Nasal and Sinus Center — Birmingham, Alabama, United States
• Arizona Desert ENT Specialists — Goodyear, Arizona, United States
• Sacramento ENT — Roseville, California, United States
• ENT Associates of South Florida — Boca Raton, Florida, United States
• ENT Associates of South Florida — Plantation, Florida, United States
• Chicago Nasal and Sinus Center — Chicago, Illinois, United States
• Baton Rouge General / Sinus and Nasal Specialists of Louisiana — Baton Rouge, Louisiana, United States
• Advocare Aroesty ENT Associates — Mount Arlington, New Jersey, United States
• UT Physicians Otorhinolaryngology - Texas Medical Center — Houston, Texas, United States
• ENT Associates of Texas — McKinney, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.