Vivaer Procedure for Nasal Congestion

(SWELL Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a procedure to address nasal congestion caused by swollen areas inside the nose, known as septal swell bodies. The treatment uses the Vivaer Arc Stylus device, which applies controlled energy to reduce these swellings and open the airways. It targets individuals whose nasal blockage improves with decongestants. Participants should be interested in a non-surgical, office-based procedure to relieve nasal obstruction. As an unphased trial, this study provides an opportunity to explore a non-surgical treatment option for nasal congestion relief.

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 prior data suggests that the Vivaer Arc Stylus is safe for treating nasal congestion?

Research has shown that the Vivaer Arc Stylus is safe and effective for treating stuffy noses. Studies found no serious side effects from the treatment. Patients reported easier breathing, and over 60% indicated they needed fewer or less frequent oral medications. This suggests the treatment is both effective and safe for long-term use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for nasal congestion, which often rely on medications like decongestants or nasal sprays, the Vivaer Procedure uses a unique approach by delivering bipolar radiofrequency energy directly to the nasal tissues. This treatment is administered using the Vivaer ARC Stylus, a disposable handheld device, which allows for targeted, minimally invasive therapy. Researchers are excited about this procedure because it offers the potential for long-lasting relief in a single session, avoiding the need for ongoing medication use or surgical intervention.

What evidence suggests that the Vivaer Arc Stylus is effective for treating nasal congestion?

Research has shown that the Vivaer Arc Stylus, which participants in this trial will receive, helps people with blocked nasal airways breathe better. In one study, 92.9% of participants reported easier breathing during exercise. Another study found that 83.3% of participants felt their symptoms improved. Many people also used fewer decongestants or stopped using them altogether, and only a few required additional treatments. Overall, these findings suggest that the Vivaer procedure can provide lasting relief for nasal congestion. ^{1 2 3 6 7}

Who Is on the Research Team?

Anais Laborde

Principal Investigator

Aerin Medical

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9437830/

Outcomes 12 Months After Temperature-Controlled ... Temperature-controlled radiofrequency device treatment of the nasal valve was associated with a sustained improvement in symptoms of nasal airway obstruction ...

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 with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).

3. 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 ...

4. aerinmedical.com aerinmedical.com/company/news-and-media/long-term-vivaer-study-demonstrates-sustained-relief-for-nasal-airway-obstruction-symptoms/

Long-Term VivAer® Study Demonstrates Sustained Relief ... Long-Term VivAer® Study Demonstrates Sustained Relief for Nasal Airway Obstruction Symptoms · 69.2% decreased or stopped decongestants · 66.7% ...

5. respiratory-therapy.com respiratory-therapy.com/disorders-diseases/chronic-pulmonary-disorders/chronic-diseases/data-vivaer-nasal-airway-obstruction-device/

Data on Effectiveness of VivAer Nasal Airway Obstruction ... Sustained Symptom Relief: 83.3% of patients were responders, with mean NOSE scores improving by 52.6% · Low Nasal Valve Reintervention Rate: 3.2% of patients ...

6. 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 ...

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

LOW-DOSE RADIOFREQUENCY FOR NASAL VALVE ... Silvers et al (2024) reported on a 2 year outcome of the VivAer System, in treating nasal airway obstruction (NAO) caused by nasal valve ...