Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

HNO-Praxis Alte Post

Status: Completed

Conditions: Nasal Obstruction, Bilateral

Treatments: Device: Vivaer® ARC Stylus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04717791

RFNV001

Details and patient eligibility

About

A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

Procedure

Other group

Description:

Subjects will be followed from the Vivaer® treatment date out to 24 months post index procedure.

Treatment:

Device: Vivaer® ARC Stylus