A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
CompAer
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).
1 other identifier
observational
400
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2025
CompletedFirst Submitted
Initial submission to the registry
March 26, 2025
CompletedFirst Posted
Study publicly available on registry
April 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 23, 2026
March 1, 2026
1.3 years
March 26, 2025
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nasal Obstruction Symptom Evaluation (NOSE) Scale
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.
3 months, 6 months, 12 months and 24 months post-procedure.
Secondary Outcomes (6)
Epworth Sleepiness Scale (ESS)
3 months, 6 months, 12 months and 24 months post-procedure.
12-item Short Form (SF-12) Survey
3 months, 6 months, 12 months and 24 months post-procedure.
Visual Analogy Scale (VAS) Score
1 week post procedure
Return to Work
3 months post procedure.
Patient Satisfaction with Procedure
3 months, 6 months, 12 months and 24 months post-procedure.
- +1 more secondary outcomes
Study Arms (2)
VivAer Arm
The VivAer treatment arm will be comprised of patients undergoing the minimally invasive VivAer procedure using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency (RF) energy to tissue when connected to the Aerin Console radiofrequency generating device. Treatments will be performed using the VivAer Stylus and Aerin Console using non-overlapping and device default settings (temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds). VivAer treatment areas will include at minimum the lateral nasal wall in the area of the upper lateral cartilage and may also involve treatment of the inferior turbinate and/or septal swell body at the discretion of the investigator according to individual patient needs.
Surgical Comparator Arm
The two surgical intervention arms will be comprised of patients undergoing surgical intervention for the treatment of NAO as follows: * Functional Rhinoplasty Arm: This arm will include patients undergoing primary functional rhinoplasty surgery for NAO addressing the nasal valve and/or lateral nasal wall and may be performed with septoplasty or turbinoplasty performed alone or in combination). This procedure may include minor aspects of cosmesis (e.g., dorsal hump reduction) at the discretion of the investigator. * Septoplasty arm: This arm will include patients undergoing a septoplasty with or without turbinate reduction as the only procedures performed for NAO.
Eligibility Criteria
Patients between the ages of 22-85 seeking treatments for nasal airway obstruction.
You may qualify if:
- 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 with/without turbinoplasty performed alone or in combination).
- Septoplasty surgery with turbinate reduction.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aerin Medicallead
Study Sites (35)
Southern Head and Neck Surgery
Alexander City, Alabama, 35010, United States
ExcelENT
Birmingham, Alabama, 35244, United States
North Alabama ENT
Huntsville, Alabama, 35801, United States
East Alabama ENT
Opelika, Alabama, 36801, United States
Arizona Desert ENT Specialists
Goodyear, Arizona, 85395, United States
Honor Health ENT
Scottsdale, Arizona, 85255, United States
Tucson ENT
Tucson, Arizona, 85704, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Alexis Furze, MD Inc
Newport Beach, California, 92663, United States
Sacramento ENT (DaVinci Research)
Roseville, California, 95661, United States
Mercy Medical Group
Sacramento, California, 95816, United States
Breathe Clear Institute
Torrance, California, 90503, United States
IMMUNOe Research Center
Denver, Colorado, 80249, United States
ENT & Allergy Associates of Florida (Boynton Beach)
Boynton Beach, Florida, 33472, United States
Advanced ENT and Allergy
Fernandina Beach, Florida, 32034, United States
ENT and Allergy Associates of Florida
Plantation, Florida, 33324, United States
ENT and Allergy Associates Of Florida
Port Saint Lucie, Florida, 34952, United States
ENT and Allergy Associates of Florida (West Palm Beach)
West Palm Beach, Florida, 33407, United States
Chicago Nasal and Sinus Center
Chicago, Illinois, 60602, United States
Chicago ENT
Chicago, Illinois, 60657, United States
Kentuckia Ear Nose & Throat
Louisville, Kentucky, 40205, United States
Dearborn ENT
Dearborn, Michigan, 48124, United States
Dearborn ENT Livonia
Livonia, Michigan, 48154, United States
Maddison ENT
New York, New York, 10016, United States
Madison ENT
New York, New York, 10016, United States
Open Sinus
New York, New York, 10019, United States
University of Rochester
Rochester, New York, 14627, United States
Bethlehem ENT /Specialty Physician Associates
Bethlehem, Pennsylvania, 18017, United States
ENT Associates of Texas
McKinney, Texas, 75070, United States
Hill Country ENT
New Braunfels, Texas, 78130, United States
Endormir Sleep Solution LLC
San Antonio, Texas, 78230, United States
Texas Facial Plastic Surgery & ENT
San Antonio, Texas, 78230, United States
Alamo ENT Associates
San Antonio, Texas, 78258, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
ENT & Allergy Associates
Puyallup, Washington, 98373, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2025
First Posted
April 11, 2025
Study Start
February 28, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share