Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

• ClinicalTrials.gov Identifier: NCT02914236
• Recruitment Status: Completed
• First Posted: September 26, 2016
• Results First Posted: March 6, 2018
• Last Update Posted: May 21, 2019
• Sponsor: Aerin Medical
• Information provided by (Responsible Party): Aerin Medical

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Nasal Obstruction	Device: Vivaer Stylus	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
• Actual Study Start Date: September 27, 2016
• Actual Primary Completion Date: July 21, 2017
• Actual Study Completion Date: August 18, 2017

Arms and Interventions

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 Name: Aerin Medical Device

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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.

Other Outcome Measures:

1. Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale [ Time Frame: Immediately after study procedure, 4-weeks ]

   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.

2. Subject Satisfaction [ Time Frame: 26 weeks ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Central California Clinical Research

Fresno, California, United States, 93720

United States, Colorado

Colorado ENT and Allergy

Colorado Springs, Colorado, United States, 80909

United States, New Jersey

ENT and Allergy Associates, LLP

Oradell, New Jersey, United States, 07649

United States, New York

ENT and Allergy Associates, LLP

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

United States, North Carolina

Piedmont Ear, Nose and Throat Associates

Winston-Salem, North Carolina, United States, 27103

United States, Texas

Ear, Nose and Throat Associates of Texas

McKinney, Texas, United States, 75070

Sponsors and Collaborators

Aerin Medical

Investigators

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

  Study Documents (Full-Text)

Documents provided by Aerin Medical:

Study Protocol and Statistical Analysis Plan  [PDF] February 1, 2017

More Information

• Responsible Party: Aerin Medical
• ClinicalTrials.gov Identifier: NCT02914236
• Other Study ID Numbers: TP258
• First Posted: September 26, 2016
• Results First Posted: March 6, 2018
• Last Update Posted: May 21, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Aerin Medical:

Nasal valve; Nasal airway obstruction

Additional relevant MeSH terms:

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