Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Aerin Medical

Status: Completed

Conditions: Nasal Obstruction

Treatments: Device: Vivaer Stylus

Study type: Interventional

Funder types: Industry

Identifiers

NCT02914236

TP258

Details and patient eligibility

About

Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.

Full description

This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Enrollment: 50 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Seeking treatment for nasal obstruction and willing to undergo an office-based procedure
• 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 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

• Prior surgical treatment of the nasal valve
• Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past twelve (12) months
• Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction
• Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms
• Known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications
• 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)

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50 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