We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03156270
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : June 16, 2021
Last Update Posted : June 16, 2021
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Aerin Medical

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction

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

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : July 12, 2019
Actual Study Completion Date : August 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Vivaer Stylus Treatment
Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area
 Device: Vivaer Stylus
Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Other Name: Aerin Medical Stylus


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change 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. Improvement (90 day score - baseline score) is signified by a negative 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.


  2. Change in VAS of Nasal Obstruction [ Time Frame: Baseline, 90 days ]

    Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject from baseline to 90 days post-study procedure. Improvement (90-day score - baseline score) is signified by a negative value.

    The visual-analog scale (VAS) of nasal obstruction is presented to the subject as a 10cm line anchored on each end by verbal descriptors: 0 = No Obstruction and 10 = Completely Obstructed. The subject is asked to place a vertical mark on the line to show the level of nasal obstruction they feel. The distance between 0 and the vertical mark made by the subject is measured and the results is expressed in centimeters. Higher scores indicate more severe obstruction.



Other Outcome Measures:
  1. Change in Peak Nasal Inspiratory Flow [ Time Frame: Baseline, 90 days ]
    Peak inspiratory flow measurements of nasal physical resistance


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complaints of nasal obstruction for at least 1 year
  • Failed maximum medical therapy (4-6 weeks of steroids)
  • 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 during office exam):

    1. Use of external nasal dilator strips (e.g., Breathe Right Strips)
    2. Q-Tip test (manual intranasal lateralization)
    3. Use of nasal stents
    4. 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 three (3) months
  • Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy
  • Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention
  • Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session
  • 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156270


Locations
Layout table for location information
United States, Ohio
The Ohio State Eye and Ear Institute
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Aerin Medical
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: Brad Otto, MD The Ohio State Eye and Ear Institute
  Study Documents (Full-Text)

Documents provided by Aerin Medical:
Study Protocol and Statistical Analysis Plan  [PDF] January 25, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Aerin Medical
ClinicalTrials.gov Identifier: NCT03156270    
Other Study ID Numbers: TP423
First Posted: May 17, 2017    Key Record Dates
Results First Posted: June 16, 2021
Last Update Posted: June 16, 2021
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Aerin Medical:
nasal valve
nasal airway obstruction
Additional relevant MeSH terms:
Layout table for MeSH terms
Airway Obstruction
Nasal Obstruction
Respiratory Insufficiency
Respiration Disorders
 Respiratory Tract Diseases
Nose Diseases
Otorhinolaryngologic Diseases