Clinical Trial: Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Aerin Medical

Current Primary Outcome:

• Improvement 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
• VAS of nasal obstruction [ Time Frame: Baseline, 90 days ]
  Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Aerin Medical

Dates:
Date Received: May 15, 2017
Date Started: June 2017
Date Completion: December 2017
Last Updated: May 15, 2017
Last Verified: May 2017