What side effects are associated with this type of intervention?

Common treatments for nasal congestion include radiofrequency energy procedures, such as the Vivaer Arc Stylus, which remodel nasal tissues. Known side effects of these treatments can include mild pain, swelling, crusting, and bleeding at the treatment site. Other general treatments for nasal congestion, such as decongestant sprays and oral medications, may cause side effects like dryness, irritation, increased heart rate, and insomnia.

What prior FDA approvals exist?

The FDA has approved various treatments for nasal congestion, including pharmacological options like decongestants and antihistamines. However, for treatments similar to the Vivaer Arc Stylus, which uses radiofrequency energy to remodel nasal tissues, the FDA has approved devices such as the VivAer Nasal Airway Remodeling device. This device uses controlled radiofrequency energy to target and reduce tissue in the nasal airway, thereby improving airflow and reducing congestion. These minimally invasive procedures offer an alternative to traditional surgical methods for patients with chronic nasal obstruction.

What other types of research exist?

Promising novel alternatives to the Vivaer Arc Stylus for treating nasal congestion in 2024 include: 1) Cryotherapy (ClariFix) which targets the posterior nasal nerve to reduce inflammation and congestion, 2) Balloon Sinuplasty, a minimally invasive procedure to open sinus passages, and 3) Biologics such as Dupilumab (Dupixent) for patients with chronic rhinosinusitis with nasal polyps. These treatments offer different mechanisms of action and have shown efficacy in clinical settings.

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N/A

Vivaer Procedure for Nasal Congestion (SWELL Trial)

N/A

Waitlist Available

Research Sponsored by Aerin Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%

Age 22 to 85 years (inclusively)

Must not have

Severe case of septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the participant's nasal obstruction symptoms and warranting surgical intervention

Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months (13 weeks) visit following baseline

Awards & highlights

No Placebo-Only Group

Summary

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).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed here but may include discomfort from the procedure, risks associated with stopping anticoagulants temporarily, and typical surgical risks like poor wound healing or infection.

Eligibility Criteria

Inclusion Criteria

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

Select...

More than half of my middle nasal passage is blocked.

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I am between 22 and 85 years old.

Exclusion Criteria

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

Select...

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

Select...

I regularly use Afrin nasal spray or take oral steroids.

Select...

I am allergic to some anesthetics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months (13 weeks) visit following baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months (13 weeks) visit following baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months (13 weeks) visit following baseline 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 Mean Change

Secondary study objectives

Number of Participants With Device Related Adverse Events

Responder Percent

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vivaer ProcedureExperimental Treatment1 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).

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for nasal congestion include the use of radiofrequency energy, decongestants, antihistamines, and nasal corticosteroids. Radiofrequency energy, as used in treatments like the Vivaer Arc Stylus, works by remodeling the nasal tissues to reduce obstruction and improve airflow. Decongestants constrict blood vessels in the nasal passages, reducing swelling and congestion. Antihistamines block histamine receptors to reduce allergic reactions and nasal inflammation. Nasal corticosteroids reduce inflammation in the nasal passages, providing long-term relief. These treatments are crucial for patients as they alleviate symptoms, improve breathing, and enhance overall quality of life.

Long-term efficacy of radiofrequency treatment of turbinate hypertrophy: a patient based point of view.Radiofrequency volumetric tissue reduction for treatment of turbinate hypertrophy: a pilot study.