What is the mechanism of action of this treatment?

The VivAer procedure uses low energy radiofrequency heating to gently reshape the nasal sidewall tissues, improving nasal airflow by reducing obstructions. This minimally-invasive technique targets the structural causes of nasal blockage without extensive surgery, offering a quicker recovery and fewer complications. Understanding this mechanism is crucial for patients as it highlights a treatment option that directly addresses the physical blockage, potentially providing more immediate and sustained relief compared to pharmacological treatments that primarily manage symptoms rather than the underlying cause.

What side effects are associated with this type of intervention?

Minimally invasive treatments for airway blockage, such as the VivAer procedure which uses low energy radiofrequency heating to reshape nasal tissues, are generally well-tolerated. Common side effects include temporary discomfort or pain, swelling, crusting, and minor bleeding. Some patients may also experience nasal dryness or congestion. Serious complications are rare but can include infection or prolonged healing time. Overall, these treatments have a relatively low risk profile compared to more invasive surgical options.

What prior FDA approvals exist?

The FDA has approved several treatments for airway blockage, particularly those involving minimally invasive techniques. One such treatment is the VivAer procedure, which uses low energy radiofrequency heating to reshape nasal tissues and improve airflow. This method is similar to other energy-based treatments like radiofrequency ablation, which has been used in various medical fields to reduce tissue volume and improve function. Additionally, traditional surgical options such as septoplasty and turbinate reduction have long been FDA-approved for treating nasal obstruction, though they are more invasive compared to procedures like VivAer.

What other types of research exist?

Promising alternatives to VivAer for airway blockage include: 1) Azelastine nasal spray, which has shown no adverse effects on nasal mucosa and ciliary activity in long-term use. 2) Ipratropium bromide, effective in reducing rhinorrhoea, particularly in non-allergic perennial rhinitis. 3) Bipolar radiofrequency thermotherapy, which has demonstrated clinical efficacy in treating allergic rhinitis with minimal side effects. 4) Local hyperthermia, which has shown significant symptom relief in perennial allergic rhinitis without long-term side effects.

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Radiofrequency Ablation

VivAer Procedure for Nasal Congestion

N/A

Recruiting

Led By Auddie Sweis, MD

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

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

Must have

Nasal obstruction, defined as ≥60 by the NOSE scale.

Be older than 18 years old

Must not have

Severe case of any of the following; septal deviation, turbinate hypertrophy, polyps, or ptotic nasal tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention.

Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be administered before the vivaer procedure and at 4, 12, and 24 weeks post procedure.

Awards & highlights

Summary

This trial is testing the VivAer procedure, which reshapes nasal tissues to improve airflow. It targets patients whose nasal obstruction isn't relieved by usual treatments. The procedure is minimally invasive and aims to improve airflow.

Who is the study for?

This trial is for adults over 18 with persistent nasal congestion not relieved by a four-week steroid spray regimen, where the nasal valve significantly contributes to obstruction. Candidates should see improvement with manual tests like Q-Tip or Cottle Maneuver. Excluded are those with severe sinusitis, allergies needing steroids, prior nasal surgeries within a year, pregnancy, lactation, anesthetic allergies, and conditions affecting wound healing.

What is being tested?

The study tests the VivAer procedure's effectiveness in improving airflow in patients with medically unexplained nasal blockages. It uses radiofrequency heating via a stylus to reshape nasal tissues minimally invasively under local anesthesia. Participants will be evaluated at follow-ups after undergoing this FDA-approved outpatient treatment.

What are the potential side effects?

While specific side effects of the VivAer procedure aren't listed here, similar treatments may cause temporary discomfort, swelling or bruising at the treatment site; nosebleeds; infection risk; and rare cases of tissue damage due to heat exposure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have severe nasal blockage.

Exclusion Criteria

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

Select...

I need surgery for severe nasal blockage due to a deviated septum, enlarged turbinates, polyps, or droopy nose tip.

Select...

I have severe sinus issues or allergies needing steroid pills.

Select...

I am not allergic to any anesthetics or antibiotics used in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be administered before the vivaer procedure and at 4, 12, and 24 weeks post procedure.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be administered before the vivaer procedure and at 4, 12, and 24 weeks post procedure.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be administered before the vivaer procedure and at 4, 12, and 24 weeks post procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PNIF Measurement

Secondary study objectives

NOSE Score

SNOT-22 Score

Trial Design

1Treatment groups

Experimental Treatment

Group I: VivAer PatientsExperimental Treatment1 Intervention

These patients will undergo the VivAer procedure, which involves the use of a stylus to deliver radiofrequency heating to the nasal sidewall to reshape the tissue. This will be done to resolve the patients' nasal obstruction. They will have PNIF measurements taken and will complete symptom assessment questionnaires before and after the VivAer procedure.

0 / 4Eligibility 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

The VivAer procedure uses low energy radiofrequency heating to gently reshape the nasal sidewall tissues, improving nasal airflow by reducing obstructions. This minimally-invasive technique targets the structural causes of nasal blockage without extensive surgery, offering a quicker recovery and fewer complications. Understanding this mechanism is crucial for patients as it highlights a treatment option that directly addresses the physical blockage, potentially providing more immediate and sustained relief compared to pharmacological treatments that primarily manage symptoms rather than the underlying cause.

Clinical pharmacology of asthma. Implications for treatment.Complementary and alternative therapy (CAM) in the treatment of allergic rhinitis.

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,617 Total Patients Enrolled

Auddie Sweis, MDPrincipal InvestigatorNorthShore University HealthSystem

Joseph Raviv, MDPrincipal InvestigatorNorthShore University HealthSystem

Media Library

VivAer Stylus (Radiofrequency Ablation) Clinical Trial Eligibility Overview. Trial Name: NCT05573919 — N/A

Airway Blockage Research Study Groups: VivAer Patients

Airway Blockage Clinical Trial 2023: VivAer Stylus Highlights & Side Effects. Trial Name: NCT05573919 — N/A

VivAer Stylus (Radiofrequency Ablation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05573919 — N/A

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