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

Description

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.

Conditions

Nasal Airway Obstruction

Study Overview

Study Details

Study overview

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.

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).

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

Condition
Nasal Airway Obstruction
Intervention / Treatment

-

Contacts and Locations

Chicago

Chicago Nasal and Sinus Center, Chicago, Illinois, United States, 60602

Louisville

Kentuckia Ear Nose & Throat, Louisville, Kentucky, United States, 40205

New York

Maddison ENT, New York, New York, United States, 10016

Bethlehem

Bethlehem ENT /Specialty Physician Associates, Bethlehem, Pennsylvania, United States, 18017

New Braunfels

Hill Country ENT, New Braunfels, Texas, United States, 78130

San Antonio

Texas Facial Plastic Surgery & ENT, San Antonio, Texas, United States, 78230

San Antonio

Alamo ENT Associates, San Antonio, Texas, United States, 78258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 and/or turbinoplasty performed alone or in combination).
  • * Septoplasty alone or in combination with turbinate reduction.
  • * 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 to address NAO symptoms.
  • * 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.

Ages Eligible for Study

22 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aerin Medical,

Study Record Dates

2027-12