VivAer: A Correlation Between Symptom Scores and Objective Findings

Study Overview
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Brief Summary
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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.

Official Title
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VivAer: A Correlation Between Symptom Scores and Objective Findings

Conditions
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Nasal Obstruction, Medically Unexplained Symptoms, Airway Obstruction, Airway Remodeling

Intervention / Treatment
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* Device: VivAer Stylus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an office-based procedure. Nasal obstruction, defined as ≥60 by the NOSE scale. The nasal valve is the primary or significant contributor to the subject's nasal obstruction as determined by the investigator, based on clinical presentation, physical examination, or nasal endoscopy. Subjects has symptomatic improvement with use of external or internal nasal dilators, Q-Tip or curette test (manual intranasal lateralization), or the Cottle Maneuver (manual lateral retraction of the cheek). Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen. Exclusion Criteria: Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past 12 months. Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy. Severe case of any of the following; septal deviation, turbinate hypertrophy, polyps, or ptotic nasal tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session. Known or suspected pregnancy, or lactation. Other medical conditions that the investigator believed would predispose subject to poor wound healing or increased surgical risk.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients who are to undergo the VivAer procedure for nasal obstruction with Dr. Auddie Sweis or Dr. Joseph Raviv will be recruited to this study. They will be issued questionnaires and have PNIF measurements taken to assess their symptoms before and after the procedure in order to determine the objective improvement in the patients' symptoms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VivAer Patients<br>These patients will undergo the VivAer procedure, which involves the use of a stylus to deliver radiofrequency heating to the nasal sidewall to reshape the tissue. This will be done to resolve the patients' nasal obstruction. They will have PNIF measurements taken and will complete symptom assessment questionnaires before and after the VivAer procedure. | Device: VivAer Stylus<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PNIF 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. | This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VivAer, Symptom Improvement