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Completed

NCT Number: NCT04549545

Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

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).

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Key information

Conditions

Nasal Airway Obstruction Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roseville Facial Plastic Surgery, Roseville, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vivaer Arc Stylus

Device

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

Device

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 outcomes

  1. Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate

    Time frame: 3 months visit following the study procedure.

    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.

Secondary outcomes

  1. Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months

    Time frame: Change from Baseline to 3 months following the study procedure.

    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.

  2. Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months

    Time frame: At or following the study procedure up to to 3 months.

    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.

Other outcomes

  1. NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score

    Time frame: 3 Month

    The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

    Measurement is # improvement in NOSE Scale score from baseline, the lower the score the less obstruction or a change to lower score indicates improvement in nasal airway obstruction.

    These data represents percent improvement in NOSE Scale score from baseline at 3 months

  2. NOSE Scale Score - 3 Month Average

    Time frame: 3 Month

    The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

    These data represents the NOSE Scale average score from baseline at 3 months

  3. NOSE Scale Score - 6 Month Average

    Time frame: 6 Month

    The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

    These data represents the NOSE Scale average score from baseline at 6 months

  4. NOSE Scale Score - 12 Month Average

    Time frame: 12 Month

    The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

    These data represents the NOSE Scale average score from baseline at 12 months

  5. NOSE Scale Score - 24 Month Average

    Time frame: 24 Month

    The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

    These data represents the NOSE Scale average score from baseline at 12 months

  6. NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE Score

    Time frame: 6 Month

    The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

    Measurement is # improvement in NOSE Scale score from baseline

    These data represents percent improvement in NOSE Scale score from baseline at 6 months

  7. NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE Score

    Time frame: 12 Month

    The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

    These data represents percent improvement in NOSE Scale score from baseline at 12 months

  8. NOSE Scale Score -24 Month Responder Rate Improvement in NOSE Score

    Time frame: 24 Month

    The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

    These data represents percent improvement in NOSE Scale score from baseline at 12 months

  9. Epworth Sleepiness Scale - 3 Month

    Time frame: 3 Months

    The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

    The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

    Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

  10. Epworth Sleepiness Scale - 6 Month

    Time frame: 6 Months

    The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

    The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

    Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

  11. Epworth Sleepiness Scale - 12 Months

    Time frame: 12 Months

    The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

    The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

    Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

  12. Epworth Sleepiness Scale - 24 Months

    Time frame: 24 Months

    The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

    The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

    Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

  13. Concomitant Medication and Mechanical Nasal Aid Analysis

    Time frame: 12 Months

    Medications tracked during the trial were antihistamines, decongestants, leukotriene inhibitors, intranasal steroids, anticholinergics, and immunotherapy. Use of nasal strips/cones was also tracked.

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study title

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

Acronym: VATRAC

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Sep 16, 2020
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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