RhinAer Procedure for Treatment of Chronic Rhinitis Study

NACompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

July 31, 2020

Primary Completion Date

April 9, 2021

Study Completion Date

December 30, 2024

Conditions
Chronic Rhinitis
Interventions
DEVICE

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.

DEVICE

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).

Trial Locations (13)

10016

Madison ENT, New York

30309

Piedmont ENT, Atlanta

33324

ENT and Allergy Associates of Florida, Plantation

33612

University of South Florida, Tampa

37232

Vanderbilt Asthma, Sinus & Allergy Program, Nashville

45267

University of Cincinnati College of Medicine, Cincinnati

60612

Rush University, Chicago

75070

ENT Associates of Texas (ENTtex), McKinney

76104

Texas Healthcare, Fort Worth

78624

Fredericksburg ENT, Fredericksburg

84403

Ogden Clinic, Ogden

90503

Breathe Clear Institute, Torrance

95661

Sacramento ENT (DaVinci Research), Roseville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Aerin Medical

INDUSTRY

NCT04533438 - RhinAer Procedure for Treatment of Chronic Rhinitis Study | Biotech Hunter | Biotech Hunter