Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

NCT ID: NCT03156270

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-19
• Study Completion Date: 2019-08-06

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.

Conditions

Nasal Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vivaer Stylus Treatment

Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area

Group Type: EXPERIMENTAL

Vivaer Stylus

Intervention Type: DEVICE

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

Interventions

Vivaer Stylus

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

Intervention Type: DEVICE

Other Intervention Names

Aerin Medical Stylus

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

Aerin Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brad Otto, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State Eye and Ear Institute

Locations

The Ohio State Eye and Ear Institute

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TP423

Identifier Type: -

Identifier Source: org_study_id