Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

NCT03156270 | Completed Results FDA Device

• 1 other identifier: TP423
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Obstruction

Keywords

nasal valve; nasal airway obstruction

Outcome Measures

Primary Outcomes (2)

• Change in NOSE Score

  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.

  Baseline, 90 days

• Change in VAS of Nasal Obstruction

  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.

  Baseline, 90 days

Other Outcomes (1)

• Change in Peak Nasal Inspiratory Flow

  Baseline, 90 days

Study Arms (1)

Vivaer Stylus Treatment

EXPERIMENTAL

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

Device: Vivaer Stylus

Interventions

Vivaer Stylus DEVICE

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

Also known as: Aerin Medical Stylus

Vivaer Stylus Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aerin Medical: lead
• Ohio State University: collaborator

Study Sites (1)

The Ohio State Eye and Ear Institute

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kai Zhao, PhD.
• Organization: Dept. of Otolaryngology-Head and Neck Surgery, The Ohio State University

zhao.1949@osu.edu

614-293-3857

Study Officials

• Brad Otto, MD

  The Ohio State Eye and Ear Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: September 19, 2017
• Primary Completion: July 12, 2019
• Study Completion: August 6, 2019
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)