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

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: NCT04277507
Recruitment Status : Active, not recruiting
First Posted : February 20, 2020
Results First Posted : May 25, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Aerin Medical

Study Description
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Brief Summary:
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)
Actual Study Start Date : February 7, 2020
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vivaer Stylus
Intervention: Procedure: thermal treatment of 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 Device


Outcome Measures
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Primary Outcome Measures :
  1. Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months [ Time Frame: 3 Month ]
    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.


Other Outcome Measures:
  1. Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure [ Time Frame: 3 months post study procedure ]
    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.

  2. Subject Reported Change in Medication Use for Nasal Obstruction Symptoms [ Time Frame: 24 Month ]
    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

  3. Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis [ Time Frame: 24 Months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT04277507


Locations
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United States, Alabama
Alabama Nasal and Sinus Center
Birmingham, Alabama, United States, 35242
United States, Arizona
Arizona Desert ENT Specialists
Goodyear, Arizona, United States, 85395
United States, California
Sacramento ENT
Roseville, California, United States, 95661
United States, Florida
ENT Associates of South Florida
Boca Raton, Florida, United States, 33487
ENT Associates of South Florida
Plantation, Florida, United States, 33324
United States, Illinois
Chicago Nasal and Sinus Center
Chicago, Illinois, United States, 60602
United States, Louisiana
Baton Rouge General / Sinus and Nasal Specialists of Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, New Jersey
Advocare Aroesty ENT Associates
Mount Arlington, New Jersey, United States, 07856
United States, Texas
UT Physicians Otorhinolaryngology - Texas Medical Center
Houston, Texas, United States, 77030
ENT Associates of Texas
McKinney, Texas, United States, 75070
Sponsors and Collaborators
Aerin Medical
  Study Documents (Full-Text)

Documents provided by Aerin Medical:
Study Protocol  [PDF] May 16, 2022
Statistical Analysis Plan  [PDF] November 8, 2022
Informed Consent Form  [PDF] June 21, 2022

More Information
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Publications of Results:
Yao WC, Ow RA, Barham HP (2021) Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study. J Otolaryngol Rhinol 7:104. doi.org/10.23937/2572-4193.1510105

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Responsible Party: Aerin Medical
ClinicalTrials.gov Identifier: NCT04277507    
Other Study ID Numbers: TP900
First Posted: February 20, 2020    Key Record Dates
Results First Posted: May 25, 2023
Last Update Posted: April 30, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Airway Obstruction
Nasal Obstruction
Respiratory Insufficiency
Respiration Disorders
 Respiratory Tract Diseases
Nose Diseases
Otorhinolaryngologic Diseases