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

Recruiting

• Conditions: Nasal Airway Obstruction

• Registration Number: NCT06922955
• Lead Sponsor: Aerin Medical

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.

Study Timeline

• Study Start: 2025-02-28
• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal Obstruction Symptom Evaluation (NOSE) Scale	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 Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	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).
12-item Short Form (SF-12) Survey	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
Visual Analogy Scale (VAS) Score	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.
Return to Work	3 months post procedure.	Assessment of the number of workdays missed within the first month due to the receiving the procedure will be collected.
Patient Satisfaction with Procedure	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.
Adverse Events	Through study completion, minimum 2 years	Physician and patient reported adverse events will be collected.

Trial Locations

Locations (7)

Chicago Nasal and Sinus Center; 🇺🇸 Chicago, Illinois, United States

Kentuckia Ear Nose & Throat; 🇺🇸 Louisville, Kentucky, United States

Maddison ENT; 🇺🇸 New York, New York, United States

Bethlehem ENT /Specialty Physician Associates; 🇺🇸 Bethlehem, Pennsylvania, United States

Hill Country ENT; 🇺🇸 New Braunfels, Texas, United States

Texas Facial Plastic Surgery & ENT; 🇺🇸 San Antonio, Texas, United States

Alamo ENT Associates; 🇺🇸 San Antonio, Texas, United States