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Radiofrequency Ablation

VivAer Procedure for Nasal Congestion

N/A
Recruiting
Led By Joseph Raviv, 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
Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen.
Subjects has symptomatic improvement with use of external or internal nasal dilators, Q-Tip or curette test (manual intranasal lateralization), or the Cottle Maneuver (manual lateral retraction of the cheek).
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

Study Summary

This trial studies an outpatient procedure (VivAer) that uses radiofrequency heating to gently reshape the tissues in the nose to improve airflow and reduce refractory nasal obstruction.

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.Check my eligibility
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.See study design
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
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I saw little to no improvement after using a nasal spray for allergies for four weeks.
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I feel better when using tools or techniques to open my nasal passages.
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My nasal blockage is mainly due to issues with my nasal valve.
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I am over 18 and willing to have a procedure to fix my blocked nose.
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I have severe nasal blockage.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PNIF Measurement
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,835 Total Patients Enrolled
Joseph Raviv, MDPrincipal InvestigatorNorthShore University HealthSystem
Auddie Sweis, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this research endeavor?

"Affirmative. Clinicaltrials.gov presents evidence that this trial is actively enrolling participants, with the initial posting date of October 7th 2022 and most recent update on December 4th 2022. This clinical trial requires 25 patients between two medical facilities."

Answered by AI

How many individuals have volunteered to take part in this scientific experiment?

"Affirmative. Clinicaltrials.gov contains evidence that this clinical trial, initially published on October 7th 2022, is seeking participants. The total number of desired enrollees is 25 and they need to come from two distinct sites."

Answered by AI
~1 spots leftby May 2024