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Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

Primary Purpose

Nasal Obstruction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivaer Stylus
Sponsored by
Aerin Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction focused on measuring nasal valve, nasal airway obstruction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State Eye and Ear Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vivaer Stylus Treatment

Arm Description

Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area

Outcomes

Primary Outcome Measures

Change in NOSE Score
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.
Change in VAS of Nasal Obstruction
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.

Secondary Outcome Measures

Full Information

First Posted
May 15, 2017
Last Updated
June 15, 2021
Sponsor
Aerin Medical
Collaborators
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03156270
Brief Title
Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction
Official Title
A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
August 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerin Medical
Collaborators
Ohio State University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
Keywords
nasal valve, nasal airway obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vivaer Stylus Treatment
Arm Type
Experimental
Arm Description
Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area
Intervention Type
Device
Intervention Name(s)
Vivaer Stylus
Other Intervention Name(s)
Aerin Medical Stylus
Intervention Description
Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Primary Outcome Measure Information:
Title
Change in NOSE Score
Description
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.
Time Frame
Baseline, 90 days
Title
Change in VAS of Nasal Obstruction
Description
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.
Time Frame
Baseline, 90 days
Other Pre-specified Outcome Measures:
Title
Change in Peak Nasal Inspiratory Flow
Description
Peak inspiratory flow measurements of nasal physical resistance
Time Frame
Baseline, 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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): 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Otto, MD
Organizational Affiliation
The Ohio State Eye and Ear Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State Eye and Ear Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

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