Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Central California Clinical Research
Fresno, California, United States
Colorado ENT and Allergy
Colorado Springs, Colorado, United States
ENT and Allergy Associates, LLP
Oradell, New Jersey, United States
Improvement in NOSE Score
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.
Time frame: Baseline, 26 weeks
NOSE Responder Rate
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.
Time frame: Baseline, 26 weeks
Percentage of Participants With Treatment-Related Adverse Events (Safety)
Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.
Time frame: Baseline through 26 weeks
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ENT and Allergy Associates, LLP
Bayside, New York, United States
ENT and Allergy Associates, LLP
New Hyde Park, New York, United States
ENT and Allergy Associates, LLP
New York, New York, United States
ENT and Allergy Associates, LLP
Staten Island, New York, United States
Piedmont Ear, Nose and Throat Associates
Winston-Salem, North Carolina, United States
Ear, Nose and Throat Associates of Texas
McKinney, Texas, United States