116
Participants
Start Date
July 31, 2020
Primary Completion Date
April 9, 2021
Study Completion Date
December 30, 2024
RhinAer Stylus
The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session.
Sham
The control treatment will be performed in the study clinic using the RhinAer 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).
Madison ENT, New York
Piedmont ENT, Atlanta
ENT and Allergy Associates of Florida, Plantation
University of South Florida, Tampa
Vanderbilt Asthma, Sinus & Allergy Program, Nashville
University of Cincinnati College of Medicine, Cincinnati
Rush University, Chicago
ENT Associates of Texas (ENTtex), McKinney
Texas Healthcare, Fort Worth
Fredericksburg ENT, Fredericksburg
Ogden Clinic, Ogden
Breathe Clear Institute, Torrance
Sacramento ENT (DaVinci Research), Roseville
Lead Sponsor
Aerin Medical
INDUSTRY