RECRUITING

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

Talk to us

Conditions

Nasal Airway ObstructionNAONasalNasal AirwayCompAerVivAernasal valve dysfunctionNOSE

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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).

Quick Facts

Study Start:2025-02-28
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06922955

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.

Ages Eligible for Study:22 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 22 to 85 years old (inclusively).
  2. * Willing and able to provide consent.
  3. * Willing and able to comply with the patient-specific requirements outlined in the study protocol.
  4. * Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
  5. * Seeking treatment for NAO
  6. * Has a NOSE Score of ≥55 indicating severe to extreme NAO.
  7. * Have a positive modified Cottle maneuver.
  8. * Planning either to undergo an intervention for NAO that includes one of the following as the primary approach.
  9. * VivAer procedure for repair of nasal valve dysfunction (may include inferior turbinate and septal swell body as additional treated areas)
  10. * 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).
  11. * Septoplasty alone or in combination with turbinate reduction.
  1. * Has had nasal surgery (including sinus surgery) within the last 3 months.
  2. * Has had a previous rhinoplasty (functional or cosmetic), septoplasty, inferior turbinate reduction, or VivAer procedure to address NAO symptoms.
  3. * 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.
  4. * Has a medical condition(s) that may impair normal healing processes or be exacerbated by the stress of surgery.
  5. * Has chronic rhinitis that is refractory to medications or rhinitis medicamentosa.
  6. * Has poorly controlled chronic rhinosinusitis disease.
  7. * Rhinoplasty is being performed primarily for cosmesis.
  8. * Is receiving, planning to receive, or has received a Latera absorbable nasal implant at any time.
  9. * 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.

Contacts and Locations

Study Contact

Desiree Hollemon
CONTACT
(503) 686-8972
dhollemon@aerinmedical.com
Tien Dang
CONTACT
(669) 256-6596
tdang@aerinmedical.com

Study Locations (Sites)

Chicago Nasal and Sinus Center
Chicago, Illinois, 60602
United States
Kentuckia Ear Nose & Throat
Louisville, Kentucky, 40205
United States
Maddison ENT
New York, New York, 10016
United States
Bethlehem ENT /Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
United States
Hill Country ENT
New Braunfels, Texas, 78130
United States
Texas Facial Plastic Surgery & ENT
San Antonio, Texas, 78230
United States
Alamo ENT Associates
San Antonio, Texas, 78258
United States

Collaborators and Investigators

Sponsor: Aerin Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-02-28
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • NAO
  • Nasal Airway Obstruction
  • Nasal
  • Nasal Airway
  • CompAer
  • VivAer
  • nasal valve dysfunction
  • NOSE

Additional Relevant MeSH Terms

  • Nasal Airway Obstruction