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Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study (VATRAC)

Primary Purpose

Nasal Airway Obstruction

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivaer ARC Stylus
Sham
Sponsored by
Aerin Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Airway Obstruction focused on measuring Nasal obstruction, NAO, Nasal valve dysfunction, Nasal airway obstruction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Roseville Facial Plastic Surgery
  • Breathe Clear Institute
  • Otolaryngology Consultants, PA
  • ENT and Allergy Associates of Florida
  • ENT Associates of South Florida
  • ENT and Allergy Associates of Florida
  • ENT of Georgia North
  • Advanced ENT and Allergy KY
  • The Centers for Advanced ENT Care
  • BreatheAmerica
  • Madison ENT
  • Charlotte Eyes Ears Nose Throat Associates
  • Piedmont ENT Associates NC
  • University of Cincinnati College of Medicine
  • Bethlehem ENT
  • ENT Associates of Texas (ENTtex)
  • Ogden Clinic
  • EVMS Ear Nose and Throat Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Vivaer Procedure

Sham Control Procedure

Arm Description

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. Each side of the nose will be treated with up to four (4) non-overlapping applications of RF energy at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Treatment settings to be used are: 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 (24 months).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 9, 2020
Last Updated
July 27, 2022
Sponsor
Aerin Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04549545
Brief Title
Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study
Acronym
VATRAC
Official Title
The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerin Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Airway Obstruction
Keywords
Nasal obstruction, NAO, Nasal valve dysfunction, Nasal airway obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
2:1 site-stratified randomization will be used to allocate participants to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure). Crossover within 30 days after 3 month follow-up visit.
Masking
Participant
Masking Description
Participant will be blinded to the study arm they are assigned to.
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vivaer Procedure
Arm Type
Active Comparator
Arm Description
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. Each side of the nose will be treated with up to four (4) non-overlapping applications of RF energy at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Treatment settings to be used are: 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 (24 months).
Arm Title
Sham Control Procedure
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Vivaer ARC Stylus
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
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).
Primary Outcome Measure Information:
Title
Nasal Obstruction Symptom Evaluation (NOSE) Scale Responder Rate
Description
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.
Time Frame
3 months visit following the study procedure.
Secondary Outcome Measure Information:
Title
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change
Description
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.
Time Frame
Change from Baseline to 3 months following the study procedure.
Title
Percentage of Participants with Treatment Related Events (Safety)
Description
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.
Time Frame
At or following the study procedure up to to 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 85 years (inclusively). Willing and able to provide informed consent. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure. Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55. 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) 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: 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. Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 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 patient's nasal obstruction symptoms and warranting surgical intervention. Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure. 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 patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Han, MD
Organizational Affiliation
EVMS Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stacey Silvers, MD
Organizational Affiliation
Madison ENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roseville Facial Plastic Surgery
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Breathe Clear Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Otolaryngology Consultants, PA
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
ENT and Allergy Associates of Florida
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
ENT Associates of South Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
ENT and Allergy Associates of Florida
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
ENT of Georgia North
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Advanced ENT and Allergy KY
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
The Centers for Advanced ENT Care
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
BreatheAmerica
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Madison ENT
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Charlotte Eyes Ears Nose Throat Associates
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Piedmont ENT Associates NC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Bethlehem ENT
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
ENT Associates of Texas (ENTtex)
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Ogden Clinic
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
EVMS Ear Nose and Throat Surgeons
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34240571
Citation
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/alr.22861. Epub 2021 Jul 9.
Results Reference
result
PubMed Identifier
36048465
Citation
Han JK, Silvers SL, Rosenthal JN, McDuffie CM, Yen DM. Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction. JAMA Otolaryngol Head Neck Surg. 2022 Oct 1;148(10):940-946. doi: 10.1001/jamaoto.2022.2293.
Results Reference
derived

Learn more about this trial

Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

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