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).

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasal Airway Obstruction

Detailed 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 by using the NOSE scale to evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
      • Southern Head and Neck Surgery
    • Birmingham, Alabama, United States, 35244
      • ExcelENT
    • Huntsville, Alabama, United States, 35801
      • North Alabama ENT
    • Opelika, Alabama, United States, 36801
      • East Alabama ENT
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Arizona Desert ENT Specialists
    • Scottsdale, Arizona, United States, 85255
      • Honor Health ENT
    • Tucson, Arizona, United States, 85704
      • Tucson ENT
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Newport Beach, California, United States, 92663
      • Alexis Furze, MD Inc
    • Roseville, California, United States, 95661
      • Sacramento ENT (DaVinci Research)
    • Sacramento, California, United States, 95816
      • Mercy Medical Group
    • Torrance, California, United States, 90503
      • Breathe Clear Institute
  • Colorado
    • Denver, Colorado, United States, 80249
      • ImmunoE Research Center
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • ENT & Allergy Associates of Florida (Boynton Beach)
    • Fernandina Beach, Florida, United States, 32034
      • Advanced ENT and Allergy
    • Plantation, Florida, United States, 33324
      • ENT and Allergy Associates of Florida
    • Port Saint Lucie, Florida, United States, 34952
      • ENT and Allergy Associates of Florida
    • West Palm Beach, Florida, United States, 33407
      • ENT and Allergy Associates of Florida (West Palm Beach)
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Chicago Nasal and Sinus Center
    • Chicago, Illinois, United States, 60657
      • Chicago ENT
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Kentuckia Ear Nose & Throat
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Dearborn ENT
    • Livonia, Michigan, United States, 48154
      • Dearborn ENT Livonia
  • New York
    • New York, New York, United States, 10016
      • Madison ENT
    • New York, New York, United States, 10016
      • Maddison ENT
    • New York, New York, United States, 10019
      • Open Sinus
    • Rochester, New York, United States, 14627
      • University of Rochester
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Bethlehem ENT /Specialty Physician Associates
  • Texas
    • McKinney, Texas, United States, 75070
      • ENT Associates of Texas
    • New Braunfels, Texas, United States, 78130
      • Hill Country ENT
    • San Antonio, Texas, United States, 78258
      • Alamo ENT Associates
    • San Antonio, Texas, United States, 78230
      • Endormir Sleep Solution LLC
    • San Antonio, Texas, United States, 78230
      • Texas Facial Plastic Surgery & ENT
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Washington
    • Puyallup, Washington, United States, 98373
      • ENT & Allergy Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 22-85 seeking treatments for nasal airway obstruction.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale (ESS)	The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated as No Chance (0), Slight (1), Moderate (2), or High Chance (3).	3 months, 6 months, 12 months and 24 months post-procedure.
12-item Short Form (SF-12) Survey	The SF-12 is one of the most widely used instruments for assessing self-reported health-related quality of life, and has been validated in numerous studies.40 The SF-12 is a general health questionnaire that consists of 12 questions which investigates the patient's perception about their state of health via 8 different dimensions: General health perception - 1 question, Physical health - 2 questions, Limited physical role function - 2 questions, Physical pain - 1 question, Vitality - 1 question, Mental health - 2 questions, Limited emotional role function - 2 questions, and Social functioning - 1 question. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score above 50 indicates better than average health-related quality of life and scores less than 50 suggest below-average health.41	3 months, 6 months, 12 months and 24 months post-procedure.
Visual Analogy Scale (VAS) Score	The Visual Analogue Scale (VAS) is a unidimensional measure of pain intensity that will be used to measure nasal pain associated with the procedure.39 A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Scores are obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the patient to indicate their current level of pain in and around the nose. Results are then assigned a score between 0 and 100.	1 week post procedure
Return to Work	Assessment of the number of workdays missed within the first month due to the receiving the procedure will be collected.	3 months post procedure.
Patient Satisfaction with Procedure	Satisfaction with the procedure is measured with a five-question, self-reported survey using a 5-point scale to assess tolerability of the procedure, ease of recovery, change in NAO symptoms, overall satisfaction with the procedure, and recommendation to others.	3 months, 6 months, 12 months and 24 months post-procedure.
Adverse Events	Physician and patient reported adverse events will be collected.	Through study completion, minimum 2 years

Collaborators and Investigators

• Sponsor: Aerin Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: VivAer; Nasal; NAO; Nasal Airway Obstruction; Nasal Airway; CompAer; nasal valve dysfunction; NOSE
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: CTP1563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No