Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
Primary Purpose
Nasal Obstruction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivaer Stylus
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Obstruction focused on measuring Nasal valve, Nasal airway obstruction
Eligibility 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
Sites / Locations
- Central California Clinical Research
- Colorado ENT and Allergy
- ENT and Allergy Associates, LLP
- ENT and Allergy Associates, LLP
- ENT and Allergy Associates, LLP
- ENT and Allergy Associates, LLP
- ENT and Allergy Associates, LLP
- Piedmont Ear, Nose and Throat Associates
- Ear, Nose and Throat Associates of Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vivaer Stylus
Arm Description
Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02914236
Brief Title
Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
Official Title
A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 27, 2016 (Actual)
Primary Completion Date
July 21, 2017 (Actual)
Study Completion Date
August 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerin Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.
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.
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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vivaer Stylus
Arm Type
Experimental
Arm Description
Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area
Intervention Type
Device
Intervention Name(s)
Vivaer Stylus
Other Intervention Name(s)
Aerin Medical Device
Intervention Description
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Primary Outcome Measure Information:
Title
Improvement in NOSE Score
Description
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.
Time Frame
Baseline, 26 weeks
Secondary Outcome Measure Information:
Title
NOSE Responder Rate
Description
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.
Time Frame
Baseline, 26 weeks
Title
Percentage of Participants With Treatment-Related Adverse Events (Safety)
Description
Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.
Time Frame
Baseline through 26 weeks
Other Pre-specified Outcome Measures:
Title
Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale
Description
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.
Time Frame
Immediately after study procedure, 4-weeks
Title
Subject Satisfaction
Description
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.
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Wolf, MD
Organizational Affiliation
Aerin Medical
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ofer Jacobowitz, MD, PhD
Organizational Affiliation
Mount Sinai Hospital, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central California Clinical Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Colorado ENT and Allergy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
ENT and Allergy Associates, LLP
City
Oradell
State/Province
New Jersey
ZIP/Postal Code
07649
Country
United States
Facility Name
ENT and Allergy Associates, LLP
City
Bayside
State/Province
New York
ZIP/Postal Code
11360
Country
United States
Facility Name
ENT and Allergy Associates, LLP
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
ENT and Allergy Associates, LLP
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
ENT and Allergy Associates, LLP
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Facility Name
Piedmont Ear, Nose and Throat Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ear, Nose and Throat Associates of Texas
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
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