Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

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

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

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction
• Intervention / Treatment: Device: Vivaer Stylus

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Central California Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Colorado ENT and Allergy
  • New Jersey
    • Oradell, New Jersey, United States, 07649
      • ENT and Allergy Associates, LLP
  • New York
    • Bayside, New York, United States, 11360
      • ENT and Allergy Associates, LLP
    • New Hyde Park, New York, United States, 11042
      • ENT and Allergy Associates, LLP
    • New York, New York, United States, 10017
      • ENT and Allergy Associates, LLP
    • Staten Island, New York, United States, 10314
      • ENT and Allergy Associates, LLP
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Ear, Nose and Throat Associates
  • Texas
    • McKinney, Texas, United States, 75070
      • Ear, Nose and Throat Associates of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vivaer Stylus; Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area	Device: Vivaer Stylus; Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area; Other Names: Aerin Medical Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in NOSE Score	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.	Baseline, 26 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale	Procedure-related pain as reported by the subject using a 100mm Visual Analog Scale (VAS), immediately post-procedure and at the 4-week follow-up visit. Higher scores indicate more severe pain. The Pain VAS is presented to the subject as a 100mm line anchored on each end by verbal descriptors: 0 = no pain and 100 = worse pain imaginable. The distance between 0 and the vertical mark made by the subject is measured and the result is expressed in millimeters.	Immediately after study procedure, 4-weeks
Subject Satisfaction	Study-specific survey to assess patient satisfaction with the discomfort of the procedure and recovery period, as well as their perceived results. The survey included 5 questions related to tolerability of the procedure, ease of recovery, change in breathing, satisfaction with treatment, and willingness to recommend treatment. Each question was scored on a 10-point scale, with 1 indicating the most negative response to the question (e.g., "very bad", "much worse", or "very dissatisfied") and 10 indicating the most favorable rating (e.g., "hardly noticeable", "much better", or "very satisfied"). Each question was individually scored and reported.	26 weeks

Collaborators and Investigators

• Sponsor: Aerin Medical
• Investigators: Study Director: Scott Wolf, MD, Aerin Medical; Principal Investigator: Ofer Jacobowitz, MD, PhD, Mount Sinai Hospital, New York, NY

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2016
• Primary Completion (Actual): July 21, 2017
• Study Completion (Actual): August 18, 2017

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Nasal airway obstruction; Nasal valve
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: TP258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No