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COMPLETED
NCT05099263
NA

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

Sponsor: Aerin Medical

View on ClinicalTrials.gov

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

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.

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