Improving nasal airflow with the VivAer procedure
VivAer: A Correlation Between Symptom Scores and Objective Findings
This study is testing if the VivAer procedure can help people with nasal obstruction breathe better by using a gentle heating technique to reshape their nasal tissues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Endeavor Health Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05573919 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center study evaluates the effectiveness of the VivAer procedure in enhancing nasal airflow for patients suffering from nasal obstruction. The VivAer technique utilizes a stylus to apply controlled low energy radiofrequency heating to reshape nasal tissues, providing a minimally invasive treatment option. Eligible participants will undergo the procedure and be monitored for objective improvements in their nasal airflow. The study aims to correlate symptom scores with these objective findings to assess the procedure's efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older experiencing significant nasal obstruction with a NOSE scale score of 60 or higher.
Not a fit: Patients who have had recent nasal surgeries or those with severe chronic sinusitis or allergies may not benefit from this procedure.
Why it matters
Potential benefit: If successful, this procedure could significantly improve the quality of life for patients with chronic nasal obstruction who have not responded to standard treatments.
How similar studies have performed: While the VivAer procedure is a newer approach, similar minimally invasive techniques have shown promise in improving nasal airflow in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an office-based procedure. * Nasal obstruction, defined as ≥60 by the NOSE scale. * The nasal valve is the primary or significant contributor to the subject's nasal obstruction as determined by the investigator, based on clinical presentation, physical examination, or nasal endoscopy. * 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). * Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen. Exclusion Criteria: * Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past 12 months. * Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy. * 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. * Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session. * Known or suspected pregnancy, or lactation. * Other medical conditions that the investigator believed would predispose subject to poor wound healing or increased surgical risk.
Where this trial is running
Chicago, Illinois and 1 other locations
- Swedish Covenant Hospital — Chicago, Illinois, United States (Recruiting)
- NorthShore Skokie Hospital — Skokie, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Auddie Sweis, MD — Endeavor Health
- Study coordinator: Riley J Medenwald, BS
- Email: RMedenwald@northshore.org
- Phone: 874-570-3944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.