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COMPLETED
NCT04549545
NA

Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

Sponsor: Aerin Medical

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).

Official title: The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

119

Start Date

2020-08-12

Completion Date

2025-03-04

Last Updated

2026-11-02

Healthy Volunteers

No

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 valves in a single study session.

DEVICE

Sham

The sham control procedure will be performed in the study clinic using the Vivaer ARC 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).

Locations (12)

Roseville Facial Plastic Surgery

Roseville, California, United States

Breathe Clear Institute

Torrance, California, United States

ENT and Allergy Associates of Florida

Coral Springs, Florida, United States

ENT Associates of South Florida

Fort Lauderdale, Florida, United States

ENT and Allergy Associates of Florida

Port Saint Lucie, Florida, United States

Advanced ENT and Allergy KY

Louisville, Kentucky, United States

Madison ENT

New York, New York, United States

Piedmont ENT Associates NC

Winston-Salem, North Carolina, United States

Bethlehem ENT

Bethlehem, Pennsylvania, United States

ENT Associates of Texas (ENTtex)

McKinney, Texas, United States

Ogden Clinic

Ogden, Utah, United States

EVMS Ear Nose and Throat Surgeons

Norfolk, Virginia, United States