Trials / Active Not Recruiting
Active Not RecruitingNCT06922955
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
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).
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Aerin Medical · Industry
- Sex
- All
- Age
- 22 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2025-02-28
- Primary completion
- 2026-06-01
- Completion
- 2027-12-01
- First posted
- 2025-04-11
- Last updated
- 2026-03-23
Locations
35 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06922955. Inclusion in this directory is not an endorsement.