An observational study in Nasal Airway Obstruction, sponsored by Aerin Medical. Active, not recruiting at 35 sites in United States. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Aerin Medical · Observational
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.
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.
Patients between the ages of 22-85 seeking treatments for nasal airway obstruction.
Planning either to undergo an intervention for NAO that includes one of the following as the primary approach:
Exclusion Criteria:
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.
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.
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.
Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.
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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.
Adverse Events
Physician and patient reported adverse events will be collected.
Time frame: Through study completion, minimum 2 years
Plan to share: No
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Aerin Medical