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Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing | Clinical Trials | Clareo Health

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Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation

NCT04717791•HNO-Praxis Alte Post

View on ClinicalTrials.gov

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 nasal airway obstruction using validated questionaires.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•Eligible subjects will NOT meet any of the following:
•1. Prior surgical treatment of the nasal valve
•2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months
•3. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
•4. Known or suspected to be pregnant or is lactating.
•5. Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure.
•6. Current participation in any study or participation in any study less than 6 weeks before study date 1.
•\-

Locations (3)

HNO-Praxis

Lichtenfels, Bavaria, Germany

HNO-Praxis Alte Post

Göttingen, Niedersachen, Germany

HNO-ZENTRUM am Kudamm

Berlin, Germany

Key Dates

Start Date

September 8, 2020

Primary Completion Date

October 4, 2022

Completion Date

October 4, 2022

Last Updated

January 18, 2023

Enrollment

118

ACTUAL participants

Conditions

Nasal Obstruction, Bilateral

Interventions

Vivaer® ARC Stylus

DEVICE