Clinical trial NCT06922955: A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Official 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).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasal Airway Obstruction
Keywords: NAO
Nasal Airway Obstruction
Nasal
Nasal Airway
CompAer
VivAer
nasal valve dysfunction
NOSE
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2025-04-11
Enrollment: 400
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 22-85 seeking treatments for nasal airway obstruction.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Nasal Obstruction Symptom Evaluation (NOSE) Scale
timeFrame: 3 months, 6 months, 12 months and 24 months post-procedure.
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 3 months, 6 months, 12 months and 24 months post-procedure.
measure: 12-item Short Form (SF-12) Survey
timeFrame: 3 months, 6 months, 12 months and 24 months post-procedure.
measure: Visual Analogy Scale (VAS) Score
timeFrame: 1 week post procedure
measure: Return to Work
timeFrame: 3 months post procedure.
measure: Patient Satisfaction with Procedure
timeFrame: 3 months, 6 months, 12 months and 24 months post-procedure.
measure: Adverse Events
timeFrame: Through study completion, minimum 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Nasal and Sinus Center
state: Illinois
city: Louisville
country: United States
facility: Kentuckia Ear Nose & Throat
state: Kentucky
city: New York
country: United States
facility: Maddison ENT
state: New York
city: Bethlehem
country: United States
facility: Bethlehem ENT /Specialty Physician Associates
state: Pennsylvania
city: New Braunfels
country: United States
facility: Hill Country ENT
state: Texas
city: San Antonio
country: United States
facility: Texas Facial Plastic Surgery & ENT
state: Texas
city: San Antonio
country: United States
facility: Alamo ENT Associates
state: Texas
Study officials:
References: