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Procedure

Vivaer Procedure for Nasal Obstruction (VATRAC Trial)

N/A
Waitlist Available
Led By Joseph Han, MD
Research Sponsored by Aerin Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months visit following the study procedure.
Awards & highlights

VATRAC Trial Summary

This trial will compare the Vivaer procedure, which uses RF energy to treat NAO, to a sham procedure.

Eligible Conditions
  • Nasal Obstruction

VATRAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are experiencing a stuffy nose and are willing to have a procedure done in the doctor's office.

VATRAC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months visit following the study procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months visit following the study procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nasal Obstruction Symptom Evaluation (NOSE) Scale Responder Rate
Secondary outcome measures
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change
Therapeutic procedure

VATRAC Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vivaer ProcedureActive Control1 Intervention
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).
Group II: Sham Control ProcedurePlacebo Group1 Intervention
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).

Find a Location

Who is running the clinical trial?

Aerin MedicalLead Sponsor
11 Previous Clinical Trials
803 Total Patients Enrolled
7 Trials studying Nasal Obstruction
452 Patients Enrolled for Nasal Obstruction
Joseph Han, MDPrincipal InvestigatorEVMS Medical Group
Stacey Silvers, MDPrincipal InvestigatorMadison ENT

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program accepting elderly participants?

"The parameters for this research trial necessitate that participants are aged between 18 to 85. Additionally, there are 4 other studies available for minors and 19 trials targeting individuals over the age of 65."

Answered by AI

Are there multiple establishments in this state that are offering the clinical trial?

"This clinical trial is available at 18 different medical centres, including ENT Associates of South Florida in Fort Lauderdale and The Centers for Advanced ENT Care in Baltimore. Bethlehem ENT located in Bethlehem also offers the treatment alongside 15 other sites."

Answered by AI

Are there particular individuals who are deemed most suitable to participate in this experiment?

"The purpose of this study is to recruit 119 individuals aged 18 and 85 who suffer from nasal airway obstruction. Furthermore, eligible participants shall demonstrate dissatisfaction with medical management as judged by the patient (i.e., failed response to decongestants, antihistamines or sprays), possess a baseline Nasal Obstruction Symptom Evaluation score of at least 55, be willing and capable to use internal nasal dilator cones in accordance with the Study Protocol's instructions, and meet all other requirements detailed therein."

Answered by AI

Is the enrollment process for this trial still ongoing?

"Regrettably, the clinical trial data available through clinicaltrials.gov reveals that this medical study is not presently searching for candidates; it was initially posted on August 12th 2020 and last updated July 27th 2022. Nonetheless, there are 23 additional studies actively recruiting patients at this time."

Answered by AI

Who else is applying?

How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Indiana
What site did they apply to?
Advanced ENT and Allergy KY
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have a deviated septum and was a candidate for turbinate reduction. I have trouble breathing through by nose especially when exercising.
PatientReceived 1 prior treatment
Recent research and studies
~26 spots leftby Mar 2025