Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)

Aerin Medical

Status: Completed

Conditions: Nasal Obstruction

Treatments: Device: Vivaer Stylus

Study type: Interventional

Funder types: Industry

Identifiers

NCT04277507

TP900

Details and patient eligibility

About

Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

Full 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 nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

1. Prior surgical treatment of the nasal valve
2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

122 participants in 1 patient group

Vivaer Stylus

Experimental group

Description:

Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area

Treatment:

Device: Vivaer Stylus