This is a prospective, single-center study. This study seeks to determine the objective improvement in nasal airflow in patients after undergoing the VivAer procedure, which involves the use of a stylus to deliver controlled and targeted low energy radiofrequency heating (heating by applying high-frequency radio waves) to the nasal sidewall to gently reshape the tissues. Patients who experience refractory, or medically unexplained, nasal obstruction often have symptoms that are not alleviated or resolved by standard non-surgical treatment options. VivAer, a recently developed, FDA-approved procedure, is one of the standard surgical treatments for nasal obstruction. Unlike most of the other established surgical treatments for nasal obstruction, however, VivAer is a minimally-invasive procedure, and it is an outpatient intervention that can be performed under local anesthetic. Eligible patients who are enrolled in the study will undergo the VivAer procedure, and will return to the clinic for three in-office follow-up visits at 4, 12, and 24 weeks after the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
This device will be used to complete its corresponding procedure, which involves reshaping a patient's nasal sidewall tissue through the delivery of radiofrequency heating.
Swedish Covenant Hospital
Chicago, Illinois, United States
RECRUITINGNorthShore Skokie Hospital
Skokie, Illinois, United States
RECRUITINGPNIF Measurement
The change in the severity of the patients' nasal obstruction will be measured using a Peak Nasal Inspiratory Flow (PNIF) meter. This meter measures nasal patency by measuring the volume of air that is inhaled per minute during normal breathing.
Time frame: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
NOSE Score
The patients will self-assess the degree of their symptoms with the Nasal Obstructive Symptom Evaluation (NOSE) questionnaire. The questionnaire consists of 5 questions ranking the severity of one's symptoms on a scale of 0-5. The responses are summed and multiplied by 20 to generate a symptom score out of 0-100. Higher scores indicate worse outcomes.
Time frame: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
SNOT-22 Score
The patients will self-assess the degree of their symptoms with the SinoNasal Outcome Test (SNOT-22) questionnaire. The questionnaire consists of 22 questions ranking the impact of a patient's symptoms on their quality of life on a scale of 0-5. The responses are summed to generate a score out of 110. Higher scores indicate worse outcomes.
Time frame: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
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