Comparing VivAer to other surgeries for nasal airway obstruction
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).
This study is testing whether the VivAer procedure for nasal airway obstruction works just as well as traditional surgeries like rhinoplasty and septoplasty.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 22 Years to 85 Years |
| Sex | All |
| Sponsor | Aerin Medical Industry-sponsored |
| Locations | 7 sites (Chicago, Illinois and 6 other locations) |
| Trial ID | NCT06922955 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the clinical outcomes of the VivAer procedure in treating nasal airway obstruction (NAO) compared to traditional surgical options like functional rhinoplasty and septoplasty. It will assess the effectiveness of these interventions using the NOSE scale, which measures the severity of nasal obstruction before and after treatment. The primary goal is to establish that VivAer is non-inferior to the alternative surgical procedures in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 85 with severe to extreme nasal airway obstruction and a positive modified Cottle maneuver.
Not a fit: Patients who have previously undergone nasal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients suffering from nasal airway obstruction.
How similar studies have performed: Other studies have shown promising results with similar approaches, but the specific comparison of VivAer to these surgical procedures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * 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. 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 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.
Where this trial is running
Chicago, Illinois and 6 other locations
- Chicago Nasal and Sinus Center — Chicago, Illinois, United States (Recruiting)
- Kentuckia Ear Nose & Throat — Louisville, Kentucky, United States (Recruiting)
- Maddison ENT — New York, New York, United States (Recruiting)
- Bethlehem ENT /Specialty Physician Associates — Bethlehem, Pennsylvania, United States (Recruiting)
- Hill Country ENT — New Braunfels, Texas, United States (Recruiting)
- Texas Facial Plastic Surgery & ENT — San Antonio, Texas, United States (Recruiting)
- Alamo ENT Associates — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Desiree Hollemon
- Email: dhollemon@aerinmedical.com
- Phone: (503) 686-8972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.