Vivaer Procedure for Nasal Congestion

(SWELL Trial)

Recruiting at 8 trial locations

Overseen By Lisa Tran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aerin Medical

Must not be taking: Oxymetazoline, Oral steroids

Disqualifiers: Rhinoplasty, Severe septal deviation, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the use of the Vivaer Arc Stylus, a device that helps shrink swollen nasal tissues, in adults with nasal blockages caused by Septal Swell Bodies (SSB).

Will I have to stop taking my current medications?

You may need to stop taking anticoagulant medications (blood thinners) during the perioperative period, which is a 3-day window on either side of the procedure. If you regularly use oxymetazoline (Afrin) nasal decongestant or oral steroids, you may not be eligible for the trial.

What data supports the effectiveness of the Vivaer treatment for nasal congestion?

A systematic review and meta-analysis found that the Vivaer System, a radiofrequency device, is effective in treating nasal obstruction caused by nasal valve collapse, offering a less invasive option with fewer complications compared to traditional surgery. ^{1 2 3 4 5}

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

The Vivaer treatment is unique because it uses a radiofrequency device to treat nasal obstruction by reshaping the nasal tissues, which can be done in an office setting under local anesthesia, offering a less invasive option with a shorter recovery time compared to traditional surgical methods. ^{2 6 7 8 9}

Research Team

Anais Laborde

Principal Investigator

Aerin Medical

Eligibility Criteria

This trial is for adults aged 22 to 85 with nasal congestion, specifically due to swollen septal bodies. Participants must have a NOSE score of at least 55, indicating significant nasal blockage, and be able to stop blood thinners around the procedure. They should not have had recent nasal surgery or plan any within 3 months after this treatment.

Inclusion Criteria

I can stop taking blood thinners around the time of my surgery.

My swollen sinus became smaller after using a decongestant.

More than half of my middle nasal passage is blocked.

Exclusion Criteria

I have a severe nasal blockage due to a deviated septum, enlarged turbinates, polyps, or drooping nose tip needing surgery.

You have other health issues that could make it harder for your body to heal from surgery or increase the risk of complications.

I have not had nose surgery in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Vivaer procedure using the Vivaer ARC Stylus to treat Septal Swell Bodies in a single session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of NOSE Scale score changes

13 weeks

1 visit (in-person) at 3 months

Long-term Follow-up

Participants are monitored for device-related adverse events and long-term outcomes

36 months

Treatment Details

Interventions

• Vivaer Arc Stylus

Trial Overview The study tests the Vivaer Arc Stylus device's effectiveness in treating Septal Swell Bodies (SSB) causing nasal obstruction. It's an office-based procedure evaluated post-market, meaning it’s already approved but further studied for clinical use outcomes.

Participant Groups

Group I: Vivaer Procedure Experimental Treatment 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 will undergo bilateral treatment of the nasal airway in a single study procedure session. Each side of the nose will be treated as follows: • Two (2) to six (6) nonoverlapping applications of RF energy are performed at the SSB per nostril. The default treatment settings will be used for the study: 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 (36 months).

Who Is Running the Clinical Trial?

Aerin Medical

Lead Sponsor

Trials

13

Recruited

930+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Custom made alar stents for nostril stenosis: a 24-month evaluation. [2015]

2. 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]

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

A Prospective Study of Outcomes of Septoplasty with Turbinate Reductions in Patients with Allergic Rhinitis. [2020]

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

One-year follow-up of a TRASER clinical trial for the treatment of nasal telangiectasias. [2019]

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

A simple and reliable method of patient evaluation in the surgical treatment of nasal obstruction. [2022]

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

Spreader Graft for Severe Deviation of Nasal Septum with Obstruction of the Internal Nasal Valve: Clinical and Functional Results. [2020]

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

A novel method for internal nasal valve reconstruction: H-graft technique. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Minimally invasive nasal valve repair: An evaluation using the NOSE scale. [2014]