Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)

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.

Inclusion Criteria:

1. Age 18 to 85 years (inclusively).

2. Willing and able to provide informed consent.

3. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.

4. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.

5. Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55.

6. Nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam):

   • Use of external nasal dilator strips (eg, Breathe Right Strips)
   • Use of internal nasal dilator cones
   • Modified Cottle Maneuver (manual elevation of the lateral nasal wall using a small instrument or cotton-tipped applicator to open the nasal valve)
   • Cottle Maneuver (manual lateral retraction of the cheek to open the nasal valve)

7. Dissatisfaction with medical management as judged by the patient. Defined as failed medical therapy (eg, decongestants, antihistamines, and/or nasal sprays for an appropriate period of time), but a positive response to internal or external nasal dilators.

Exclusion Criteria:

1. Prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement.
2. Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 months.
3. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the patient's nasal obstruction symptoms and warranting surgical intervention.
4. Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure.
5. Known or suspected to be pregnant or is lactating.
6. Participating in another clinical research study.
7. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.