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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

Age 18 to 85 years (inclusively).

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

Must not have

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.

Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month

Summary

This trial is testing a procedure that uses heat energy to help people with blocked nasal passages breathe better.

Who is the study for?

This trial is for adults aged 18-85 with nasal airway obstruction who haven't found relief from decongestants, antihistamines, or nasal sprays. Candidates should have a NOSE Scale score ≥ 55 and respond positively to temporary measures like nasal strips or cones. Exclusions include prior nasal surgeries, recent rhinoplasty/septoplasty/turbinate reduction/FESS, severe septal deviation/turbinates/polyps/ptotic nose tip requiring surgery, pregnancy/lactation, participation in another study, or conditions affecting wound healing.

What is being tested?

The Vivaer procedure using radiofrequency energy is being tested against a sham (fake) procedure to see which is more effective at treating nasal airway obstruction. Participants will be randomly assigned to receive either the actual Vivaer treatment or a simulated one without therapeutic effect.

What are the potential side effects?

Potential side effects of the Vivaer procedure may include discomfort at the treatment site, swelling inside the nose leading to temporary increased blockage post-procedure, possible minor bleeding or infection risk due to manipulation of nasal tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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I often have a blocked nose.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had nose surgery involving the side wall or cartilage.

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I plan to have or had nasal surgery the same day or within 6 months after the Vivaer procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Other study objectives

Concomitant Medication and Mechanical Nasal Aid Analysis

Epworth Sleepiness Scale - 12 Months

Epworth Sleepiness Scale - 24 Months

+10 more

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).

0 / 4Eligibility criteria met