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).
Status: Active_not_recruiting
Location: See all (35) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 85
Healthy Volunteers: f
View:
• Age 22 to 85 years old (inclusively).
• Willing and able to provide consent.
• Willing and able to comply with the patient-specific requirements outlined in the study protocol.
• Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
• Seeking treatment for NAO
• Has a NOSE Score of ≥55 indicating severe to extreme NAO.
• Have a positive modified Cottle maneuver.
• Planning either to undergo an intervention for NAO that includes one of the following as the primary approach:
‣ VivAer procedure for repair of nasal valve dysfunction (may include inferior turbinate and septal swell body as additional treated areas)
⁃ Functional rhinoplasty surgery addressing the nasal valve and/or lateral nasal wall (may be combined with septoplasty with/without turbinoplasty performed alone or in combination).
⁃ Septoplasty surgery with turbinate reduction.
Locations
United States
Alabama
Southern Head and Neck Surgery
Alexander City
ExcelENT
Birmingham
North Alabama ENT
Huntsville
East Alabama ENT
Opelika
Arizona
Arizona Desert ENT Specialists
Goodyear
Honor Health ENT
Scottsdale
Tucson ENT
Tucson
California
Cedars Sinai Medical Center
Los Angeles
Alexis Furze, MD Inc
Newport Beach
Sacramento ENT (DaVinci Research)
Roseville
Mercy Medical Group
Sacramento
Breathe Clear Institute
Torrance
Colorado
IMMUNOe Research Center
Denver
Florida
ENT & Allergy Associates of Florida (Boynton Beach)
Boynton Beach
Advanced ENT and Allergy
Fernandina Beach
ENT and Allergy Associates of Florida
Plantation
ENT and Allergy Associates Of Florida
Port Saint Lucie
ENT and Allergy Associates of Florida (West Palm Beach)
West Palm Beach
Illinois
Chicago ENT
Chicago
Chicago Nasal and Sinus Center
Chicago
Kentucky
Kentuckia Ear Nose & Throat
Louisville
Michigan
Dearborn ENT
Dearborn
Dearborn ENT Livonia
Livonia
New York
Maddison ENT
New York
Madison ENT
New York
Open Sinus
New York
University of Rochester
Rochester
Pennsylvania
Bethlehem ENT /Specialty Physician Associates
Bethlehem
Texas
ENT Associates of Texas
Mckinney
Hill Country ENT
New Braunfels
Alamo ENT Associates
San Antonio
Endormir Sleep Solution LLC
San Antonio
Texas Facial Plastic Surgery & ENT
San Antonio
Virginia
University of Virginia
Charlottesville
Washington
ENT & Allergy Associates
Puyallup
Time Frame
Start Date:2025-02-28
Completion Date:2027-12
Participants
Target number of participants:400
Treatments
VivAer Arm
The VivAer treatment arm will be comprised of patients undergoing the minimally invasive VivAer procedure using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency (RF) energy to tissue when connected to the Aerin Console radiofrequency generating device. Treatments will be performed using the VivAer Stylus and Aerin Console using non-overlapping and device default settings (temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds). VivAer treatment areas will include at minimum the lateral nasal wall in the area of the upper lateral cartilage and may also involve treatment of the inferior turbinate and/or septal swell body at the discretion of the investigator according to individual patient needs.
Surgical Comparator Arm
The two surgical intervention arms will be comprised of patients undergoing surgical intervention for the treatment of NAO as follows:~* Functional Rhinoplasty Arm: This arm will include patients undergoing primary functional rhinoplasty surgery for NAO addressing the nasal valve and/or lateral nasal wall and may be performed with septoplasty or turbinoplasty performed alone or in combination). This procedure may include minor aspects of cosmesis (e.g., dorsal hump reduction) at the discretion of the investigator.~* Septoplasty arm: This arm will include patients undergoing a septoplasty with or without turbinate reduction as the only procedures performed for NAO.