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Completed

NCT Number: NCT03156270

Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

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

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Key information

Conditions

Nasal Obstruction Airway Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State Eye and Ear Institute

Columbus, Ohio, 43212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • Use of external nasal dilator strips (e.g., Breathe Right Strips)
  • Q-Tip test (manual intranasal lateralization)
  • Use of nasal stents
  • 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

Treatment and study plan

Vivaer Stylus

Device

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

Other names: Aerin Medical Stylus

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Change in Peak Nasal Inspiratory Flow

    Time frame: Baseline, 90 days

    Peak inspiratory flow measurements of nasal physical resistance

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Collaborators

  • Ohio State University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2017
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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