VivAer: A Correlation Between Symptom Scores and Objective Findings

NorthShore University HealthSystem

Status: Enrolling

Conditions: Nasal Obstruction; Airway Remodeling; Airway Obstruction; Medically Unexplained Symptoms

Treatments: Device: VivAer Stylus

Study type: Interventional

Funder types: Other

Identifiers

NCT05573919

EH22-177

Details and patient eligibility

About

This is a prospective, single-center study. This study seeks to determine the objective improvement in nasal airflow in patients after undergoing the VivAer procedure, which involves the use of a stylus to deliver controlled and targeted low energy radiofrequency heating (heating by applying high-frequency radio waves) to the nasal sidewall to gently reshape the tissues. Patients who experience refractory, or medically unexplained, nasal obstruction often have symptoms that are not alleviated or resolved by standard non-surgical treatment options. VivAer, a recently developed, FDA-approved procedure, is one of the standard surgical treatments for nasal obstruction. Unlike most of the other established surgical treatments for nasal obstruction, however, VivAer is a minimally-invasive procedure, and it is an outpatient intervention that can be performed under local anesthetic. Eligible patients who are enrolled in the study will undergo the VivAer procedure, and will return to the clinic for three in-office follow-up visits at 4, 12, and 24 weeks after the procedure.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

VivAer Patients

Experimental group

Description:

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.

Treatment:

Device: VivAer Stylus