Vivaer Procedure for Nasal Obstruction

(VATRAC Trial)

No longer recruiting at 17 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aerin Medical

Disqualifiers: Prior nasal surgery, Severe septal deviation, Pregnancy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Vivaer procedure, which uses radiofrequency (RF) energy, can more effectively treat nasal airway obstruction (NAO) compared to a sham (fake) procedure. The Vivaer procedure applies RF energy to specific parts of the nose to open blocked nasal passages. This trial targets individuals who have tried nasal strips or sprays but still experience constant stuffy noses due to nasal valve issues. Participants should primarily attribute their nasal obstruction to the nasal valve and have found little relief from other treatments. As an unphased trial, this study provides an opportunity to explore a new treatment option for those who have not found relief from existing solutions.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions dissatisfaction with medical management, suggesting that participants may have already tried and not found relief from medications like decongestants, antihistamines, or nasal sprays.

What prior data suggests that the Vivaer procedure is safe for treating nasal airway obstruction?

Research has shown that the Vivaer procedure, which uses radio waves to treat blocked noses, is generally well-tolerated. Studies have found that patients experience significant relief from nasal symptoms without serious side effects. The treatment gently heats and reshapes the nasal passages, with positive results lasting up to three years. This indicates the procedure is both effective and safe.

Jacobowitz et al. (2019) studied the procedure's safety and found it suitable even for individuals with previous nasal surgeries, which can sometimes cause nasal valve collapse. Additionally, a clinical summary confirmed the Vivaer treatment's safety for patients with nasal blockages, showing positive outcomes.

These findings suggest the Vivaer procedure is a safe option for those experiencing nasal blockages. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Vivaer Procedure is unique because it uses a novel approach to alleviate nasal obstruction. Unlike traditional treatments, such as medications or invasive surgeries, the Vivaer Procedure employs a disposable handheld device to deliver bipolar radiofrequency energy precisely to the nasal tissue. This technique aims to reshape the nasal valves non-invasively, offering a potentially quicker recovery and fewer risks compared to surgical options. Researchers are excited because this method could provide effective relief with minimal downtime.

What evidence suggests that the Vivaer procedure is effective for nasal obstruction?

Research has shown that the Vivaer procedure, which participants in this trial may receive, effectively treats blocked nasal airways. In one study, 92.9% of patients reported improved breathing during exercise. Additionally, over 60% of patients required fewer oral medications after the treatment. The benefits appear to last, with improvements in breathing and sleep quality continuing for up to three years. These findings suggest that the Vivaer procedure can significantly aid individuals with breathing problems due to nasal blockage. ^{1 2 3 4 6}

Who Is on the Research Team?

Joseph Han, MD

Principal Investigator

EVMS Medical Group

Stacey Silvers, MD

Principal Investigator

Madison ENT

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My nasal blockage is mainly due to my nasal valve and improves with certain temporary measures.

You use internal nasal dilator cones.

Willing and able to provide informed consent.

Exclusion Criteria

Participating in another clinical research study.

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

I have not had nose or sinus surgery in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Vivaer procedure or a sham procedure for nasal airway obstruction in a single session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using NOSE and Epworth Sleepiness Scales

24 months

Multiple visits at 1, 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Sham
• Vivaer® Procedure

Trial Overview 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.

How Is the Trial Designed?

Group I: Vivaer Procedure Active Control 1 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 Procedure Placebo Group 1 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).

Who Is Running the Clinical Trial?

Aerin Medical

Lead Sponsor

Trials

13

Recruited

930+

Citations

1. vivaer.com vivaer.com/hcp/

Nasal Airway Remodeling | Non-Invasive | Proven Results 92.9% of patients reported improved breathing through their nose during exercise or exertion.2. >60% of patients reported using fewer or less frequent oral ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04549545?term=VATRAC&limit=10&rank=1

Vivaer® Procedure for Treatment of Nasal Airway ... 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 ...

3. aerinmedical.com aerinmedical.com/company/news-and-media/vivaer-continues-to-demonstrate-long-term-effectiveness-and-safety-for-nasal-airway-obstruction-treatment-in-third-study-published-with-three-year-follow-up-results/

Study Shows Positive Results After Treatment with VivAer Sustained Quality-of-Life Improvements in Patients Three Years After Nasal Valve Treatment Using TCRF with VivAer for NAO.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11947858/

Temperature‐Controlled Radiofrequency Treatment of the ... Treatment with the TCRF device for nasal valve obstruction resulted in sustained improvements in nasal obstruction symptoms and sleep quality over a 3-year ...

5. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2177889.pdf

LOW-DOSE RADIOFREQUENCY FOR NASAL VALVE ... outcomes of using temperature-controlled radiofrequency treatment (VivAer) to repair nasal valve collapse through 48 months. Of the 49 ...

6. vivaer.com vivaer.com/wp-content/uploads/2022/02/MKT1324.A_VivAer-Pivotal-2Y-Clinical-Summary.pdf

CLINICAL SUMMARY The results of this study demonstrate that VivAer treatment of the nasal valve in select patients presenting with nasal obstruction was safe and was associated ...