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NCT Number: NCT06922955

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

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.

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Key information

Conditions

Nasal Airway Obstruction Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern Head and Neck Surgery, Alexander City, Alabama, United States

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About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 with/without turbinoplasty performed alone or in combination).
  • 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)

Treatment and study plan

Primary outcomes

  1. Nasal Obstruction Symptom Evaluation (NOSE) Scale

    Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.

    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.

Secondary outcomes

  1. Epworth Sleepiness Scale (ESS)

    Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.

    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).

  2. 12-item Short Form (SF-12) Survey

    Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.

    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. Visual Analogy Scale (VAS) Score

    Time frame: 1 week post procedure

    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.

  4. Return to Work

    Time frame: 3 months post procedure.

    Assessment of the number of workdays missed within the first month due to the receiving the procedure will be collected.

  5. Patient Satisfaction with Procedure

    Time frame: 3 months, 6 months, 12 months and 24 months post-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.

  6. Adverse Events

    Time frame: Through study completion, minimum 2 years

    Physician and patient reported adverse events will be collected.

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study 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).

Acronym: CompAer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 11, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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