VivAer: A Correlation Between Symptom Scores and Objective Findings

Launched by ENDEAVOR HEALTH · Oct 6, 2022

Keywords

ClinConnect Summary

This clinical trial, called VivAer, is studying a new procedure to help people who have trouble breathing through their noses due to nasal obstruction. Many patients have symptoms that don’t get better with regular treatments, and this trial aims to see how well the VivAer procedure improves airflow in the nose. The VivAer procedure uses a special device to gently heat and reshape the tissues inside the nose, and it can be done in a doctor’s office with local anesthesia, meaning patients stay awake but won’t feel pain.

To be eligible for the study, participants must be adults 18 years or older who have significant nasal obstruction issues. They should have tried other treatments without much success and should have specific problems related to their nasal passage. Those interested will undergo the VivAer procedure and return for follow-up visits at 4, 12, and 24 weeks to see how well the treatment worked. This study is important because it offers a new, less invasive option for patients struggling with nasal obstruction.

Gender

ALL

Eligibility 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.