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
Sex
ALL
Min age
22 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* 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:
1. VivAer procedure for repair of nasal valve dysfunction (may include inferior turbinate and septal swell body as additional treated areas)
2. 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).
3. Septoplasty surgery with turbinate reduction.
Exclusion Criteria:
* Has had nasal surgery (including sinus surgery) within the last 3 months.
* Has had a previous rhinoplasty (functional or cosmetic), septoplasty, inferior turbinate reduction, or VivAer procedure.
* Has extreme nasal pathology, a history of extreme nasal injuries, or an abnormal nasal condition (e.g. septal perforation or empty nose syndrome) that may be exacerbated by surgery.
* Has a medical condition(s) that may impair normal healing processes or be exacerbated by the stress of surgery.
* Has chronic rhinitis that is refractory to medications or rhinitis medicamentosa.
* Has poorly controlled chronic rhinosinusitis disease.
* Rhinoplasty is being performed primarily for cosmesis.
* Is receiving, planning to receive, or has received a Latera absorbable nasal implant at any time.
* Planning to have sinus or cosmetic surgery (e.g., functional endoscopic sinus surgery, cosmetic rhinoplasty) or a surgery involving the airway (e.g., hypoglossal nerve stimulation surgery, uvuloplasty, tonsillectomy, tongue base or soft palate interventions) within 6 months following enrollment.
* Is having an adjunctive surgical procedure performed with the primary NAO procedure (e.g. functional rhinoplasty with concha bullosa reduction, septoplasty with turbinate reduction performed with functional endoscopic sinus surgery)
Primary outcome measure(s)
Nasal Obstruction Symptom Evaluation (NOSE) Scale — 3 months, 6 months, 12 months and 24 months post-procedure. To evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint, this study will use the well-known subjective patient-reported outcome measure, the NOSE Scale. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure outcomes of participants treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale with a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.
Individual participant success (treatment responder) is based on NOSE Scale improvement defined as a ≥ 24 point improvement (decrease) in NOSE Scale score from baseline to the 3-month evaluation.
Trial sites (35)
Facility
City
Region
Status
Southern Head and Neck Surgery
Alexander City
Alabama
ExcelENT
Birmingham
Alabama
North Alabama ENT
Huntsville
Alabama
East Alabama ENT
Opelika
Alabama
Arizona Desert ENT Specialists
Goodyear
Arizona
Honor Health ENT
Scottsdale
Arizona
Tucson ENT
Tucson
Arizona
Cedars Sinai Medical Center
Los Angeles
California
Alexis Furze, MD Inc
Newport Beach
California
Sacramento ENT (DaVinci Research)
Roseville
California
Mercy Medical Group
Sacramento
California
Breathe Clear Institute
Torrance
California
IMMUNOe Research Center
Denver
Colorado
ENT & Allergy Associates of Florida (Boynton Beach)
Boynton Beach
Florida
Advanced ENT and Allergy
Fernandina Beach
Florida
ENT and Allergy Associates of Florida
Plantation
Florida
ENT and Allergy Associates Of Florida
Port Saint Lucie
Florida
ENT and Allergy Associates of Florida (West Palm Beach)
West Palm Beach
Florida
Chicago Nasal and Sinus Center
Chicago
Illinois
Chicago ENT
Chicago
Illinois
Kentuckia Ear Nose & Throat
Louisville
Kentucky
Dearborn ENT
Dearborn
Michigan
Dearborn ENT Livonia
Livonia
Michigan
Maddison ENT
New York
New York
Madison ENT
New York
New York
Open Sinus
New York
New York
University of Rochester
Rochester
New York
Bethlehem ENT /Specialty Physician Associates
Bethlehem
Pennsylvania
ENT Associates of Texas
McKinney
Texas
Hill Country ENT
New Braunfels
Texas
Endormir Sleep Solution LLC
San Antonio
Texas
Texas Facial Plastic Surgery & ENT
San Antonio
Texas
Alamo ENT Associates
San Antonio
Texas
University of Virginia
Charlottesville
Virginia
ENT & Allergy Associates
Puyallup
Washington
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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