Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

Nasal Airway Obstruction Clinical Trial

— VATRAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04549545
• Other study ID #: CTP1006
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2022
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: May 31, 2023
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Nasal Airway Obstruction
• Nasal Obstruction

Intervention

Device:
• Vivaer ARC Stylus
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.
• Sham
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).

Locations

Country	Name	City	State
United States	BreatheAmerica	Albuquerque	New Mexico
United States	ENT of Georgia North	Atlanta	Georgia
United States	The Centers for Advanced ENT Care	Baltimore	Maryland
United States	Bethlehem ENT	Bethlehem	Pennsylvania
United States	Otolaryngology Consultants, PA	Boynton Beach	Florida
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Charlotte Eyes Ears Nose Throat Associates	Concord	North Carolina
United States	ENT and Allergy Associates of Florida	Coral Springs	Florida
United States	ENT Associates of South Florida	Fort Lauderdale	Florida
United States	Advanced ENT and Allergy KY	Louisville	Kentucky
United States	ENT Associates of Texas (ENTtex)	McKinney	Texas
United States	Madison ENT	New York	New York
United States	EVMS Ear Nose and Throat Surgeons	Norfolk	Virginia
United States	Ogden Clinic	Ogden	Utah
United States	ENT and Allergy Associates of Florida	Port Saint Lucie	Florida
United States	Roseville Facial Plastic Surgery	Roseville	California
United States	Breathe Clear Institute	Torrance	California
United States	Piedmont ENT Associates NC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aerin Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Silvers SL, Rosenthal JN, McDuffie CM, Yen DM, Han JK. Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial. Int Forum Allergy Rhinol. 2021 Dec;11(12):1676-1684. doi: 10.1002 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Obstruction Symptom Evaluation (NOSE) Scale 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.; The study will measure the responder rate, which is defined as at least 1 NOSE Scale class improvement or an improvement (decrease) in NOSE Scale score of 20% or more from baseline at the 3-month evaluation.	3 months visit following the study procedure.
Secondary	Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change	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.	Change from Baseline to 3 months following the study procedure.
Secondary	Percentage of Participants with Treatment Related Events (Safety)	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.	At or following the study procedure up to to 3 months.