The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
119
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Roseville Facial Plastic Surgery
Roseville, California, United States
Breathe Clear Institute
Torrance, California, United States
ENT and Allergy Associates of Florida
Coral Springs, Florida, United States
Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses.
Time frame: 3 months visit following the study procedure.
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months
The NOSE Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. This study will measure the mean change in NOSE Scale from baseline to 3 months after procedure.
Time frame: Change from Baseline to 3 months following the study procedure.
Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, seriousness, intensity, duration and outcome will be documented.
Time frame: At or following the study procedure up to to 3 months.
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ENT Associates of South Florida
Fort Lauderdale, Florida, United States
ENT and Allergy Associates of Florida
Port Saint Lucie, Florida, United States
Advanced ENT and Allergy KY
Louisville, Kentucky, United States
Madison ENT
New York, New York, United States
Piedmont ENT Associates NC
Winston-Salem, North Carolina, United States
Bethlehem ENT
Bethlehem, Pennsylvania, United States
ENT Associates of Texas (ENTtex)
McKinney, Texas, United States
...and 2 more locations