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Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

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ClinicalTrials.gov Identifier: NCT03156270
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Aerin Medical

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Arm Intervention/treatment
Experimental: Vivaer Stylus
Thermal treatment of the 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 Stylus




Primary Outcome Measures :
  1. Improvement 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

  2. VAS of nasal obstruction [ Time Frame: Baseline, 90 days ]
    Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject


Other Outcome Measures:
  1. Endoscopic exam score [ Time Frame: Baseline, immediately post-treatment, 90 days ]
    Lund-Kennedy endoscopic exam scores

  2. Peak nasal inspiratory flow [ Time Frame: Baseline, 90 days ]
    Peak inspiratory flow measurements of nasal physical resistance

  3. Cone beam CT scan [ Time Frame: Baseline, 90 days ]
    Evaluation of disease severity through computerized tomography (CT) staging; computational modeling of nasal airflow based on CT scan

  4. SNOT-22 [ Time Frame: Baseline, 90 days ]
    Sino-Nasal Outcome Test (SNOT-22) assessment as evaluated by the study subject



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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

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


Contacts
Contact: Scott Wolf, MD 650-434-3247 scott@aerinmedical.com

Locations
United States, Ohio
The Ohio State Eye and Ear Institute Recruiting
Columbus, Ohio, United States, 43212
Contact: Brad Otto, MD    614-366-6221      
Sponsors and Collaborators
Aerin Medical
Ohio State University
Investigators
Principal Investigator: Brad Otto, MD The Ohio State Eye and Ear Institute

Responsible Party: Aerin Medical
ClinicalTrials.gov Identifier: NCT03156270     History of Changes
Other Study ID Numbers: TP423
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: 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