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

Sponsor
Aerin Medical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04277507
Collaborator
(none)
125
Enrollment
12
Locations
1
Arm
33.7
Anticipated Duration (Months)
10.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Vivaer Stylus
 N/A

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

Study Type:
Interventional
Actual Enrollment :
125 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 :
Feb 7, 2020
Actual Primary Completion Date :
Nov 30, 2020
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

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 Names:
  • Aerin Medical Device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in Nasal Obstructive Symptom Evaluation (NOSE) Scores [Baseline, 3 months, 6 months, 12 months and 24 months post study procedure]

      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 severe nasal obstructive symptoms.

    2. Improvement in symptoms as documented by the subject in the Quality of Life (QOL) Questionnaire. [3 months, 6 months, 12 months and 24 months post study procedure]

      Subject self reported study-specific Quality of Life (QOL) Questionnaire - The QOL questionnaire will be used to gain better understanding of the impact of nasal obstruction on the subject's daily activities, feelings, symptoms and medication use. Symptoms will be recorded on a scale of 0, No problem to 5, Problem as bad as it could be. A satisfaction with outcome of Vivaer treatment will be asked in one question on a scale where 1=symptoms have no effect on daily activity to 10=symptoms completely effect daily activity. The QOL will be completed by the subject at 3 months, 6 months, 12 months and 24 months post study procedure.

    Other Outcome Measures

    1. Subject-reported Visual Analog Scale (VAS) Pain scores in relation to the area treated by the study procedure [3 months post study procedure]

      Visual Analog Scale (VAS) Pain scores will be evaluated at 3 months post study procedure. VAS scores range from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

    2. Subject reported medication use for nasal obstruction symptoms [3 months, 6 months, 12 months and 24 months post study procedure]

      Evaluate change 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. Subject reported type and frequency of adverse events [3 months, 6 months, 12 months and 24 months post study procedure]

      Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Alabama Nasal and Sinus Center Birmingham Alabama United States 35242
    2 Arizona Desert ENT Specialists Goodyear Arizona United States 85395
    3 Sacramento ENT Roseville California United States 95661
    4 ENT Associates of South Florida Boca Raton Florida United States 33487
    5 ENT Associates of South Florida Plantation Florida United States 33324
    6 Chicago Nasal and Sinus Center Chicago Illinois United States 60602
    7 Baton Rouge General / Sinus and Nasal Specialists of Louisiana Baton Rouge Louisiana United States 70809
    8 New Orleans Sinus Center / Tandem Clinical Research Metairie Louisiana United States 70072
    9 Advocare Aroesty ENT Associates Mount Arlington New Jersey United States 07856
    10 Houston ENT and Allergy Houston Texas United States 77010
    11 UT Physicians Otorhinolaryngology - Texas Medical Center Houston Texas United States 77030
    12 ENT Associates of Texas McKinney Texas United States 75070

    Sponsors and Collaborators

    • Aerin Medical

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aerin Medical
    ClinicalTrials.gov Identifier:
    NCT04277507
    Other Study ID Numbers:
    • TP900
    First Posted:
    Feb 20, 2020
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Airway Obstruction
    Nasal Obstruction

    Study Results

    No Results Posted as of Jan 6, 2022