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Clinical Trials in the USA / NCT06922955
Active, not recruiting Observational

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

NCT06922955 · tracked via the Priya Life Science USA tracker
Sponsor
Aerin Medical
Phase
Observational
Started
2025-02-28
Last updated
2026-03-23

Condition(s) studied

Nasal Airway Obstruction

Study 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

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)

Trial sites (35)

FacilityCityRegionStatus
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.

View NCT06922955 on ClinicalTrials.gov ↗ ← All trials in the USA