Clinical trial NCT03156270: Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction
Official title: A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Keywords: nasal valve
nasal airway obstruction
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
First posted: 2017-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction

Detailed description: This is a non-significant risk, prospective, non-randomized study to evaluate subjective and objective measures of nasal obstruction both before and after treatment with the Vivaer Stylus. The Stylus is used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Eligibility criteria: Inclusion Criteria:

* Complaints of nasal obstruction for at least 1 year
* Failed maximum medical therapy (4-6 weeks of steroids)
* 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 during office exam):

  1. Use of external nasal dilator strips (e.g., Breathe Right Strips)
  2. Q-Tip test (manual intranasal lateralization)
  3. Use of nasal stents
  4. 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
* Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy
* Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention
* Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session
* 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

Primary outcomes:
measure: Change in NOSE Score
timeFrame: Baseline, 90 days
measure: Change in VAS of Nasal Obstruction
timeFrame: Baseline, 90 days
Secondary outcomes:
Other outcomes:
measure: Change in Peak Nasal Inspiratory Flow
timeFrame: Baseline, 90 days
Locations:
city: Columbus
country: United States
facility: The Ohio State Eye and Ear Institute
state: Ohio
Study officials:
affiliation: The Ohio State Eye and Ear Institute
name: Brad Otto, MD
role: PRINCIPAL_INVESTIGATOR
References: