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ACTIVE NOT RECRUITING
NCT06922955

A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.

Sponsor: Aerin Medical

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.

Official title: A Prospective, Open-label, Multi-center, Non-inferiority Study Comparing VivAer® to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction (The CompAer Study).

Key Details

Gender

All

Age Range

22 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2025-02-28

Completion Date

2027-12

Last Updated

2026-03-23

Healthy Volunteers

No

Locations (35)

Southern Head and Neck Surgery

Alexander City, Alabama, United States

ExcelENT

Birmingham, Alabama, United States

North Alabama ENT

Huntsville, Alabama, United States

East Alabama ENT

Opelika, Alabama, United States

Arizona Desert ENT Specialists

Goodyear, Arizona, United States

Honor Health ENT

Scottsdale, Arizona, United States

Tucson ENT

Tucson, Arizona, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Alexis Furze, MD Inc

Newport Beach, California, United States

Sacramento ENT (DaVinci Research)

Roseville, California, United States

Mercy Medical Group

Sacramento, California, United States

Breathe Clear Institute

Torrance, California, United States

IMMUNOe Research Center

Denver, Colorado, United States

ENT & Allergy Associates of Florida (Boynton Beach)

Boynton Beach, Florida, United States

Advanced ENT and Allergy

Fernandina Beach, Florida, United States

ENT and Allergy Associates of Florida

Plantation, Florida, United States

ENT and Allergy Associates Of Florida

Port Saint Lucie, Florida, United States

ENT and Allergy Associates of Florida (West Palm Beach)

West Palm Beach, Florida, United States

Chicago Nasal and Sinus Center

Chicago, Illinois, United States

Chicago ENT

Chicago, Illinois, United States

Kentuckia Ear Nose & Throat

Louisville, Kentucky, United States

Dearborn ENT

Dearborn, Michigan, United States

Dearborn ENT Livonia

Livonia, Michigan, United States

Maddison ENT

New York, New York, United States

Madison ENT

New York, New York, United States

Open Sinus

New York, New York, United States

University of Rochester

Rochester, New York, United States

Bethlehem ENT /Specialty Physician Associates

Bethlehem, Pennsylvania, United States

ENT Associates of Texas

McKinney, Texas, United States

Hill Country ENT

New Braunfels, Texas, United States

Endormir Sleep Solution LLC

San Antonio, Texas, United States

Texas Facial Plastic Surgery & ENT

San Antonio, Texas, United States

Alamo ENT Associates

San Antonio, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

ENT & Allergy Associates

Puyallup, Washington, United States