129
Participants
Start Date
October 5, 2020
Primary Completion Date
June 30, 2021
Study Completion Date
December 20, 2024
RhinAer ARC Stylus
The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG815), which is a cleared (FDA - K192471) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. RhinAer has CE Marking in EU. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy was cleared for use in the US (FDA - K162810) and has CE Marking in the EU (CE639608).
Piedmont ENT Associates, Winston-Salem
ENT Associates of South Florida, Boca Raton
Florida ENT and Allergy, Tampa
ENT and Allergy Associates of Florida, Port Saint Lucie
Advanced ENT and Allergy, Louisville
Chicago Nasal and Sinus Center, Chicago
Baton Rouge General / Sinus and Nasal Specialists of Louisiana, Baton Rouge
ENT and Allergy Associates of Texas, McKinney
Fort Worth ENT, Fort Worth
Arizona Desert ENT Specialists, Goodyear
University of California, San Francisco, San Francisco
Sacramento ENT, Roseville
HNO-ZENTRUM am Kudamm, Berlin
Universitatsklinikum Carl Gustav Carus Dresden, Dresden
Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen, Göttingen
Lead Sponsor
Aerin Medical
INDUSTRY