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Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

NCT04549545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-08-28

Study results available
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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).

Conditions

  • Nasal Airway 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 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).

Sponsors & Collaborators

  • Aerin Medical

    lead INDUSTRY

Principal Investigators

  • Joseph Han, MD · EVMS Medical Group

  • Stacey Silvers, MD · Madison ENT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-12
Primary Completion
2021-03-10
Completion
2025-03-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04549545 on ClinicalTrials.gov