Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Not Applicable

Completed

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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Improvement in NOSE Score	Baseline, 26 weeks	Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive value. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity.

Secondary Outcome Measures

Name	Time	Method
NOSE Responder Rate	Baseline, 26 weeks	Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment.
Percentage of Participants With Treatment-Related Adverse Events (Safety)	Baseline through 26 weeks	Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.

Locations (5): Piedmont Ear, Nose and Throat Associates
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Winston-Salem, North Carolina, United States
Ear, Nose and Throat Associates of Texas
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McKinney, Texas, United States
Central California Clinical Research
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Fresno, California, United States
ENT and Allergy Associates, LLP
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Staten Island, New York, United States
Colorado ENT and Allergy
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Colorado Springs, Colorado, United States