Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

Aerin Medical

Status: Completed

Conditions: Nasal Obstruction

Treatments: Device: Vivaer Stylus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03156270

TP423

Details and patient eligibility

About

This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction

Full description

This is a non-significant risk, prospective, non-randomized study to evaluate subjective and objective measures of nasal obstruction both before and after treatment with the Vivaer Stylus. The Stylus is used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Complaints of nasal obstruction for at least 1 year

• Failed maximum medical therapy (4-6 weeks of steroids)

• Nasal Obstruction Symptom Evaluation (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 during office exam):

  1. Use of external nasal dilator strips (e.g., Breathe Right Strips)
  2. Q-Tip test (manual intranasal lateralization)
  3. Use of nasal stents
  4. Cottle Maneuver (manual lateral retraction of the cheek)

Exclusion criteria

• Prior surgical treatment of the nasal valve
• Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
• Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy
• Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention
• Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session
• Known or suspected to be pregnant, or is lactating
• Other medical conditions which in the opinion of the investigator could 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)

---

20 participants in 1 patient group

Vivaer Stylus Treatment

Experimental group

Description:

Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area

Treatment:

Device: Vivaer Stylus