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Completed

NCT Number: NCT04277507

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

Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Nasal and Sinus Center, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vivaer Stylus

Device

Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Other names: Aerin Medical Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study title

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

Acronym: AERWAY

Important dates

Study start
2020
Primary completion
2020
Study completion
2024
First posted
Feb 20, 2020
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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