Clinical Trials in the USA / NCT06922955
Active, not recruiting
Observational
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
NCT06922955 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Nasal Airway Obstruction
Study 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.
Eligibility
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)
Primary outcome measure(s)
- 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.
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern Head and Neck Surgery | Alexander City | Alabama | |
| ExcelENT | Birmingham | Alabama | |
| North Alabama ENT | Huntsville | Alabama | |
| East Alabama ENT | Opelika | Alabama | |
| Arizona Desert ENT Specialists | Goodyear | Arizona | |
| Honor Health ENT | Scottsdale | Arizona | |
| Tucson ENT | Tucson | Arizona | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| Alexis Furze, MD Inc | Newport Beach | California | |
| Sacramento ENT (DaVinci Research) | Roseville | California | |
| Mercy Medical Group | Sacramento | California | |
| Breathe Clear Institute | Torrance | California | |
| IMMUNOe Research Center | Denver | Colorado | |
| ENT & Allergy Associates of Florida (Boynton Beach) | Boynton Beach | Florida | |
| Advanced ENT and Allergy | Fernandina Beach | Florida | |
| ENT and Allergy Associates of Florida | Plantation | Florida | |
| ENT and Allergy Associates Of Florida | Port Saint Lucie | Florida | |
| ENT and Allergy Associates of Florida (West Palm Beach) | West Palm Beach | Florida | |
| Chicago Nasal and Sinus Center | Chicago | Illinois | |
| Chicago ENT | Chicago | Illinois | |
| Kentuckia Ear Nose & Throat | Louisville | Kentucky | |
| Dearborn ENT | Dearborn | Michigan | |
| Dearborn ENT Livonia | Livonia | Michigan | |
| Maddison ENT | New York | New York | |
| Madison ENT | New York | New York | |
| Open Sinus | New York | New York | |
| University of Rochester | Rochester | New York | |
| Bethlehem ENT /Specialty Physician Associates | Bethlehem | Pennsylvania | |
| ENT Associates of Texas | McKinney | Texas | |
| Hill Country ENT | New Braunfels | Texas | |
| Endormir Sleep Solution LLC | San Antonio | Texas | |
| Texas Facial Plastic Surgery & ENT | San Antonio | Texas | |
| Alamo ENT Associates | San Antonio | Texas | |
| University of Virginia | Charlottesville | Virginia | |
| ENT & Allergy Associates | Puyallup | Washington |
More Aerin Medical trials in the USA
A Study of RhinAer Stylus for Treating Chronic Rhinitis
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06922955 on ClinicalTrials.gov ↗ ← All trials in the USA