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A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Sponsor: Aerin Medical
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
Conditions
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