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Completed

NCT Number: NCT02914236

Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Evaluation of the Aerin Medical Device used for the treatment of nasal 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

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central California Clinical Research, Fresno, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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. Improvement in NOSE Score

    Time frame: Baseline, 26 weeks

    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 outcomes

  1. NOSE Responder Rate

    Time frame: Baseline, 26 weeks

    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.

  2. Percentage of Participants With Treatment-Related Adverse Events (Safety)

    Time frame: Baseline through 26 weeks

    Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.

Other outcomes

  1. Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale

    Time frame: Immediately after study procedure, 4-weeks

    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.

  2. Subject Satisfaction

    Time frame: 26 weeks

    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.

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study title

A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2016
Registry last updated
May 21, 2019

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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