Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

Overview

This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction

Full Title of Study: “A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 12, 2019

Detailed Description

This is a non-significant risk, prospective, non-randomized study to evaluate subjective and objective measures of nasal obstruction both before and after treatment with the Vivaer Stylus. The Stylus is used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Interventions

  • Device: Vivaer Stylus
    • Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Arms, Groups and Cohorts

  • Experimental: Vivaer Stylus Treatment
    • Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area

Clinical Trial Outcome Measures

Primary Measures

  • Change in NOSE Score
    • Time Frame: Baseline, 90 days
    • Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 90 days post-study procedure. Improvement (90 day score – baseline score) is signified by a negative value. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity.
  • Change in VAS of Nasal Obstruction
    • Time Frame: Baseline, 90 days
    • Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject from baseline to 90 days post-study procedure. Improvement (90-day score – baseline score) is signified by a negative value. The visual-analog scale (VAS) of nasal obstruction is presented to the subject as a 10cm line anchored on each end by verbal descriptors: 0 = No Obstruction and 10 = Completely Obstructed. The subject is asked to place a vertical mark on the line to show the level of nasal obstruction they feel. The distance between 0 and the vertical mark made by the subject is measured and the results is expressed in centimeters. Higher scores indicate more severe obstruction.

Participating in This Clinical Trial

Inclusion Criteria

  • Complaints of nasal obstruction for at least 1 year – Failed maximum medical therapy (4-6 weeks of steroids) – Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at Baseline – Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or during office exam): 1. Use of external nasal dilator strips (e.g., Breathe Right Strips) 2. Q-Tip test (manual intranasal lateralization) 3. Use of nasal stents 4. Cottle Maneuver (manual lateral retraction of the cheek) Exclusion Criteria:

  • Prior surgical treatment of the nasal valve – Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) 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 nose 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 to be pregnant, or is lactating – Other medical conditions which in the opinion of the investigator could predispose the subject to poor wound healing or increased surgical risk

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aerin Medical
  • Collaborator
    • Ohio State University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Brad Otto, MD, Principal Investigator, The Ohio State Eye and Ear Institute

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