Status:
COMPLETED
Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing
Lead Sponsor:
HNO-Praxis Alte Post
Collaborating Sponsors:
Aerin Medical
Conditions:
Nasal Obstruction, Bilateral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction
Detailed Description
The primary objective of this post-market study is to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nas...
Eligibility Criteria
Inclusion
- Eligible subject will meet all the following:
- 1\. Age 18 or older 2. Willing and able to provide informed consent 3. Willing and able to comply with the study protocol 4. Seeking treatment for nasal obstruction 5. NOSE score of ≥ 60 at Baseline 6. 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
- Eligible subjects will NOT meet any of the following:
- Prior surgical treatment of the nasal valve
- Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months
- Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
- Known or suspected to be pregnant or is lactating.
- Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure.
- Current participation in any study or participation in any study less than 6 weeks before study date 1.
- \-
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2022
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04717791
Start Date
September 8 2020
End Date
October 4 2022
Last Update
January 18 2023
Active Locations (3)
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1
HNO-Praxis
Lichtenfels, Bavaria, Germany, 96215
2
HNO-Praxis Alte Post
Göttingen, Niedersachen, Germany, 37073
3
HNO-ZENTRUM am Kudamm
Berlin, Germany, 10629