Clinical Trial: Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Brief Summary: Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.

Detailed Summary: This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when 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, 26 weeks ]

Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NOSE Responder Rate [ Time Frame: Baseline, 26 weeks ]
    Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment.
  • Incidence of Treatment-Related Adverse Events (Safety) [ Time Frame: Baseline through 26 weeks ]
    Characterization of the type and frequency of adverse events reported during or following the study procedure, throughout the follow-up period.


Original Secondary Outcome: Same as current

Information By: Aerin Medical

Dates:
Date Received: September 22, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: May 3, 2017
Last Verified: May 2017