Status:
COMPLETED
Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
Lead Sponsor:
Aerin Medical
Conditions:
Nasal Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
Detailed Description
Prospective, Multicenter, Non-randomized Study of the Aerin Medical Vivaer® ARC Stylus for Nasal Airway Obstruction to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the...
Eligibility Criteria
Inclusion
- Age 18 or older
- Willing and able to provide informed consent
- Willing and able to comply with the study protocol
- Seeking treatment for nasal obstruction
- NOSE score of ≥ 60 at Baseline
- Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):
- Use of external nasal dilator strips (e.g., Breathe Right Strips)
- Q-Tip test (manual intranasal lateralization)
- Use of nasal stents
- Cottle Maneuver (manual lateral retraction of the cheek)
Exclusion
- Prior surgical treatment of the nasal valve
- Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
- Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
- Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
Key Trial Info
Start Date :
February 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04277507
Start Date
February 7 2020
End Date
October 11 2024
Last Update
May 4 2025
Active Locations (10)
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1
Alabama Nasal and Sinus Center
Birmingham, Alabama, United States, 35242
2
Arizona Desert ENT Specialists
Goodyear, Arizona, United States, 85395
3
Sacramento ENT
Roseville, California, United States, 95661
4
ENT Associates of South Florida
Boca Raton, Florida, United States, 33487