Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

• ClinicalTrials.gov Identifier: NCT03156270
• Recruitment Status: Completed
• First Posted: May 17, 2017
• Results First Posted: June 16, 2021
• Last Update Posted: June 16, 2021
• Sponsor: Aerin Medical
• Collaborator: Ohio State University
• Information provided by (Responsible Party): Aerin Medical

Study Description

Brief Summary:

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

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus
• Actual Study Start Date: September 19, 2017
• Actual Primary Completion Date: July 12, 2019
• Actual Study Completion Date: August 6, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vivaer Stylus Treatment; Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area	Device: Vivaer Stylus; Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area; Other Name: Aerin Medical Stylus

Outcome Measures

Primary Outcome Measures :

1. Change in NOSE Score [ Time Frame: Baseline, 90 days ]

   Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 90 days post-study procedure. Improvement (90 day score - baseline score) is signified by a negative 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.

2. Change in VAS of Nasal Obstruction [ Time Frame: Baseline, 90 days ]

   Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject from baseline to 90 days post-study procedure. Improvement (90-day score - baseline score) is signified by a negative value.

   The visual-analog scale (VAS) of nasal obstruction is presented to the subject as a 10cm line anchored on each end by verbal descriptors: 0 = No Obstruction and 10 = Completely Obstructed. The subject is asked to place a vertical mark on the line to show the level of nasal obstruction they feel. The distance between 0 and the vertical mark made by the subject is measured and the results is expressed in centimeters. Higher scores indicate more severe obstruction.

Other Outcome Measures:

1. Change in Peak Nasal Inspiratory Flow [ Time Frame: Baseline, 90 days ]
   Peak inspiratory flow measurements of nasal physical resistance

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

The Ohio State Eye and Ear Institute

Columbus, Ohio, United States, 43212

Sponsors and Collaborators

Aerin Medical

Ohio State University

Investigators

• Principal Investigator: Brad Otto, MD; The Ohio State Eye and Ear Institute

  Study Documents (Full-Text)

Documents provided by Aerin Medical:

Study Protocol and Statistical Analysis Plan  [PDF] January 25, 2019

More Information

• Responsible Party: Aerin Medical
• ClinicalTrials.gov Identifier: NCT03156270
• Other Study ID Numbers: TP423
• First Posted: May 17, 2017
• Results First Posted: June 16, 2021
• Last Update Posted: June 16, 2021
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• 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; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases