The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)

Study Overview
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Brief Summary
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Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).

Detailed Description
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Prospective, Open-Label, Multicenter, Single Arm Study of the Aerin Medical Vivaer ARC Stylus to treat Septal Swell Bodies (SSB) to improve symptoms in adults diagnosed with nasal obstruction attributed to SSB.

Official Title
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The Vivaer Procedure for Treatment of the Septal Swell Bodies for Airway Obstruction - A Prospective Open-Label Multicenter Study (SWELL)

Conditions
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Nasal Obstruction

Intervention / Treatment
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* Device: Vivaer Arc Stylus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 22 to 85 years (inclusively). Seeking treatment for nasal obstruction and willing to undergo an office-based procedure. Baseline NOSE score ≥ 55. Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%. Reduction in size of the SSB after application of topical decongestant on a cotton plug directly to the SSB region. Improvement in the symptoms of nasal obstruction after SSB decongestion suggesting that the SSB may play a role in nasal obstruction. Willing and able to withhold anticoagulant medications during the perioperative period (3-day window on either side). Willing and able to provide informed consent. Willing and able to comply with the participant-specific requirements outlined in the study protocol. Exclusion Criteria: Rhinoplasty, septoplasty, inferior turbinate (IT) reduction, or other surgical nasal procedures within the preceding 6 months. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the participant's nasal obstruction symptoms and warranting surgical intervention. Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure. Known or suspected allergies or contraindications for any general or local anesthetic agents. Known or suspected to be pregnant or is lactating. Participating in another clinical research study. Other medical conditions which in the opinion of the investigator would predispose the participant to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study. Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids. For sites participating in the CT substudy only: Active sinus condition (eg, significant sinus diseases, infection or polyp formation) identified by CT.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vivaer Procedure<br>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 will undergo bilateral treatment of the nasal airway in a single study procedure session. Each side of the nose will be treated as follows: • Two (2) to six (6) nonoverlapping applications of RF energy are performed at the SSB per nostril. The default treatment settings will be used for the study: temperature 60 C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat (touch up) procedures will be permitted after the initial procedure through the end of the study (36 months). | Device: Vivaer Arc Stylus<br>* 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 airway in a single study session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change | The primary endpoint is improvement in self-reported Nasal Obstruction Symptom Evaluation (NOSE) Scale score from baseline recorded at the screening evaluation to 13 weeks after the procedure. | 3 months (13 weeks) visit following screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Percent | Responder percent: A responder is defined as at least 1 NOSE Scale class improvement or an improvement (decrease) in NOSE Scale score of 20% or more from baseline to 13 weeks after the procedure. | 3 months (13 weeks) visit following baseline | 
| Device Related Adverse Events | Frequency of device-related and procedure-related serious adverse events, including frequency of septal perforation during the procedure, through the 3-month evaluation. | At or following the study procedure up to 3 months. |