Vivaer Procedure for Nasal Obstruction

(VATRAC Trial)

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

119 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the Vivaer® Procedure treatment for nasal obstruction?

Research suggests that the Vivaer® Procedure, which uses radiofrequency energy to reshape nasal tissues, can effectively treat nasal obstruction caused by nasal valve collapse. Studies indicate that this treatment can be performed in an office setting with local anesthesia, offering a less invasive option with a quicker recovery compared to traditional surgery. ^{1 2 3 4 5}

How does the Vivaer treatment for nasal obstruction differ from other treatments?

The Vivaer treatment is unique because it uses a bipolar radiofrequency device to reshape the nasal airway by applying heat to the upper lateral cartilage, which can be done in an office setting under local anesthesia, offering a less invasive option compared to traditional surgery. ^{1 3 4 6 7}

Research Team

Joseph Han, MD

Principal Investigator

EVMS Medical Group

Stacey Silvers, MD

Principal Investigator

Madison ENT

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Airwayplasty: long-term outcome of nasal wall lateralisation. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Patient experience of nasal obstruction and its clinical assessment. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Could the use of a new novel bipolar radiofrequency device (Aerin) improve nasal valve collapse? A systematic review and meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Temperature Profile Measurement From Radiofrequency Nasal Airway Reshaping Device. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Patients` evaluation for the surgical management of nasal obstruction. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Internal nasal implant to correct nasal valve obstruction. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Nasal valve surgery. [2022]