The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

September 14, 2021

Primary Completion Date

April 27, 2022

Study Completion Date

October 16, 2024

Conditions
Nasal Obstruction
Interventions
DEVICE

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.

Trial Locations (9)

10009

Mount Sinai, New York

10016

Madison ENT, New York

14627

University of Rochester, Rochester

37203

Vanderbilt Asthma, Sinus & Allergy Program, Nashville

45267

University of Cincinnati College of Medicine, Cincinnati

60602

Chicago Nasal and Sinus Center, Chicago

60612

Rush University, Chicago

78258

Alamo ENT Associates, San Antonio

80923

Colorado Otolaryngology Associates LLC, Colorado Springs

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Aerin Medical

INDUSTRY

NCT05099263 - The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL) | Biotech Hunter | Biotech Hunter