NCT04549545

Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Aerin Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.

Conditions

• Nasal Airway Obstruction

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-08-12
• Primary completion: 2021-03-10
• Completion: 2025-03-04
• First posted: 2020-09-16
• Last updated: 2025-08-28
• Results posted: 2024-06-12

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study