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NCT06922955 · ClinicalTrials.gov registry record
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
A clinical trial of Nasal Airway Obstruction, sponsored by Aerin Medical.
- Active
- Registry status
- 400
- Enrollment target
- 20
- Study locations
NCT06922955: Active study of Nasal Airway Obstruction, sponsored by Aerin Medical.
NCT06922955 is a study of Nasal Airway Obstruction that is active but no longer recruiting, run by Aerin Medical. The registered enrollment target is 400 participants, above the 58-participant average among 3 other Nasal Airway Obstruction trials with a reported enrollment target (590% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06922955, a study of Nasal Airway Obstruction, is active but no longer recruiting, sponsored by Aerin Medical.
- ACTIVE NOT RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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, wh
Conditions Studied
Study Locations (20)
California
- Cedars Sinai Medical Center - Los Angeles
- Alexis Furze, MD Inc - Newport Beach
- Sacramento ENT (DaVinci Research) - Roseville
- Mercy Medical Group - Sacramento
- Breathe Clear Institute - Torrance
Florida
- ENT & Allergy Associates of Florida (Boynton Beach) - Boynton Beach
- Advanced ENT and Allergy - Fernandina Beach
- ENT and Allergy Associates of Florida - Plantation
- ENT and Allergy Associates Of Florida - Port Saint Lucie
- ENT and Allergy Associates of Florida (West Palm Beach) - West Palm Beach
Alabama
- Southern Head and Neck Surgery - Alexander City
- ExcelENT - Birmingham
- North Alabama ENT - Huntsville
- East Alabama ENT - Opelika
Arizona
- Arizona Desert ENT Specialists - Goodyear
- Honor Health ENT - Scottsdale
- Tucson ENT - Tucson
Illinois
- Chicago Nasal and Sinus Center - Chicago
- Chicago ENT - Chicago
Colorado
- IMMUNOe Research Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2027-12 |
What the registry record for NCT06922955 still lists
NCT06922955 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 58-participant average among 3 other Nasal Airway Obstruction trials with a reported enrollment target (590% higher).
The record links to 1 condition, with Nasal Airway Obstruction appearing as the primary indexed condition, and to 0 interventions.
NCT06922955 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06922955 about?
NCT06922955 is a clinical study titled "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.
What is the current status of trial NCT06922955?
This trial is currently active not recruiting. The enrollment target is 400 participants. The study started on 2025-02-28. Estimated completion is 2027-12.
What conditions does trial NCT06922955 study?
This clinical trial studies the following conditions: Nasal Airway Obstruction.
Who is sponsoring clinical trial NCT06922955?
This trial is sponsored by Aerin Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06922955 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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