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Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study
Sponsor: Aerin Medical
Summary
The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
Official title: The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
119
Start Date
2020-08-12
Completion Date
2025-03-04
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Vivaer ARC Stylus
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Sham
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Locations (12)
Roseville Facial Plastic Surgery
Roseville, California, United States
Breathe Clear Institute
Torrance, California, United States
ENT and Allergy Associates of Florida
Coral Springs, Florida, United States
ENT Associates of South Florida
Fort Lauderdale, Florida, United States
ENT and Allergy Associates of Florida
Port Saint Lucie, Florida, United States
Advanced ENT and Allergy KY
Louisville, Kentucky, United States
Madison ENT
New York, New York, United States
Piedmont ENT Associates NC
Winston-Salem, North Carolina, United States
Bethlehem ENT
Bethlehem, Pennsylvania, United States
ENT Associates of Texas (ENTtex)
McKinney, Texas, United States
Ogden Clinic
Ogden, Utah, United States
EVMS Ear Nose and Throat Surgeons
Norfolk, Virginia, United States