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The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)
Sponsor: Aerin Medical
Summary
Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).
Official title: The Vivaer Procedure for Treatment of the Septal Swell Bodies for Airway Obstruction - A Prospective Open-Label Multicenter Study (SWELL)
Key Details
Gender
All
Age Range
22 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2021-09-14
Completion Date
2024-10-16
Last Updated
2026-11-02
Healthy Volunteers
Yes
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 airway in a single study session.
Locations (9)
Colorado Otolaryngology Associates LLC
Colorado Springs, Colorado, United States
Chicago Nasal and Sinus Center
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
Mount Sinai
New York, New York, United States
Madison ENT
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Vanderbilt Asthma, Sinus & Allergy Program
Nashville, Tennessee, United States
Alamo ENT Associates
San Antonio, Texas, United States