Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Overview

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

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

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 21, 2017

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Vivaer Stylus
    • Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area

Clinical Trial Outcome Measures

Primary Measures

  • 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. Improvement (baseline score – 26-week score) is signified by a positive 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.

Secondary Measures

  • 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.
  • Percentage of Participants With Treatment-Related Adverse Events (Safety)
    • Time Frame: Baseline through 26 weeks
    • Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.

Participating in This Clinical Trial

Inclusion Criteria

  • Seeking treatment for nasal obstruction and willing to undergo an office-based procedure – 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 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 twelve (12) months – Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction – Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms – Known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications – 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: 22 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aerin Medical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Scott Wolf, MD, Study Director, Aerin Medical
    • Ofer Jacobowitz, MD, PhD, Principal Investigator, Mount Sinai Hospital, New York, NY

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