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Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)

Primary Purpose

Nasal Obstruction

Status
Active
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 or older
  2. Willing and able to provide informed consent
  3. Willing and able to comply with the study protocol
  4. Seeking treatment for nasal obstruction
  5. NOSE score of ≥ 60 at Baseline

  6. 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:

  1. Prior surgical treatment of the nasal valve
  2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
  3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
  4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

Sites / Locations

  • Alabama Nasal and Sinus Center
  • Arizona Desert ENT Specialists
  • Sacramento ENT
  • ENT Associates of South Florida
  • ENT Associates of South Florida
  • Chicago Nasal and Sinus Center
  • Baton Rouge General / Sinus and Nasal Specialists of Louisiana
  • New Orleans Sinus Center / Tandem Clinical Research
  • Advocare Aroesty ENT Associates
  • Houston ENT and Allergy
  • UT Physicians Otorhinolaryngology - Texas Medical Center
  • ENT 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

Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2020
Last Updated
May 2, 2023
Sponsor
Aerin Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04277507
Brief Title
Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
Acronym
AERWAY
Official Title
A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerin Medical

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
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
Detailed Description
Prospective, Multicenter, Non-randomized Study of the Aerin Medical Vivaer® ARC Stylus for Nasal Airway Obstruction to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating 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
122 (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
Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
Description
Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms.
Time Frame
3 Month
Other Pre-specified Outcome Measures:
Title
Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure
Description
The Pain VAS will be used to rate pain associated with the treatment (Hawker, Mian et al. 2011). Subjects are asked to mark their pain level on a 10 cm line anchored by verbal descriptors: 0 = no pain and 10 = worst pain imaginable. The study staff will measure with a metric ruler from the 0, the beginning of the line, to the vertical mark made by the subject. The result, expressed in millimeters, will represent the subject's VAS Pain Score with 100 being the worst pain imaginable.
Time Frame
3 months post study procedure
Title
Subject Reported Change in Medication Use for Nasal Obstruction Symptoms
Description
Evaluate change (reduction) in medication used for nasal obstruction symptoms from Baseline to follow up timepoints post study procedure of 3 months, 6 months, 12 months and 24 months
Time Frame
24 Month
Title
Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis
Description
Mean change in NOSE score from Baseline to 24 months post study procedure. Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning sever nasal obstructive symptoms
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Willing and able to provide informed consent Willing and able to comply with the study protocol Seeking treatment for nasal obstruction 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 three (3) months Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
Facility Information:
Facility Name
Alabama Nasal and Sinus Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Arizona Desert ENT Specialists
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Sacramento ENT
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
ENT Associates of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
ENT Associates of South Florida
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Chicago Nasal and Sinus Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Baton Rouge General / Sinus and Nasal Specialists of Louisiana
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
New Orleans Sinus Center / Tandem Clinical Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Advocare Aroesty ENT Associates
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
Houston ENT and Allergy
City
Houston
State/Province
Texas
ZIP/Postal Code
77010
Country
United States
Facility Name
UT Physicians Otorhinolaryngology - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
ENT 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

Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction

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