Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

• Sponsor: Aerin Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03156270
• Collaborator: Ohio State University (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.5
• Patients Per Site Per Month: 0.9

Study Details

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	N/A

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
• 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: Sep 19, 2017
• Actual Primary Completion Date: Jul 12, 2019
• Actual Study Completion Date: Aug 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 Names: Aerin Medical Stylus

Outcome Measures

Primary Outcome Measures

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

   Peak inspiratory flow measurements of nasal physical resistance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - Jan 25, 2019

More Information

Publications

None provided.

• Responsible Party: Aerin Medical
• ClinicalTrials.gov Identifier: NCT03156270
• Other Study ID Numbers: TP423
• First Posted: May 17, 2017
• Last Update Posted: Jun 16, 2021
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Recruitment Details	Patients with a history of chronic nasal obstruction for at least 1 year were prospectively enrolled at this tertiary academic center.

Arm/Group Title	Vivaer Stylus Treatment
Arm/Group Description	Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Period Title: Overall Study
STARTED	20
COMPLETED	18
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Subjects Followed Through 90 Days
Arm/Group Description	Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Overall Participants	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.4 (17.3)
Sex: Female, Male (Count of Participants)
Female	6 33.3%
Male	12 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	18 100%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 5.6%
Black or African American	1 5.6%
White	16 88.9%
Region of Enrollment (participants) [Number]
United States	18 100%
Nasal Obstruction Symptom Evaluation (NOSE) score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	78.9 (11.6)

Outcome Measures

1. Primary Outcome

Title	Change in NOSE Score
Description	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.
Time Frame	Baseline, 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Followed Through 90 Days
Arm/Group Description	Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-44.5 (27.0)

2. Primary Outcome

Title	Change in VAS of Nasal Obstruction
Description	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.
Time Frame	Baseline, 90 days

Outcome Measure Data

Analysis Population Description

Includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment

Arm/Group Title	Subjects Followed Through 90 Days
Arm/Group Description	Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-2.6 (2.2)

3. Other Pre-specified Outcome

Title	Change in Peak Nasal Inspiratory Flow
Description	Peak inspiratory flow measurements of nasal physical resistance
Time Frame	Baseline, 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Followed Through 90 Days - Baseline Data	Subjects Followed Through 90 Days - 90 Day Data
Arm/Group Description	Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment	Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Measure Participants	18	18
Mean (Standard Deviation) [ml/sec]	60.2 (34.5)	72.4 (43.7)

Adverse Events

Time Frame	From procedure through 90-day evaluation
Adverse Event Reporting Description	Subjects were queried for adverse events after the procedure and at the 90-day evaluation visit. Details of events were documented on a standardized case report form.
Arm/Group Title	Subjects Followed Through 90 Days
Arm/Group Description	Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
All Cause Mortality
	Subjects Followed Through 90 Days
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Serious Adverse Events
	Subjects Followed Through 90 Days
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Subjects Followed Through 90 Days
	Affected / at Risk (%)	# Events
Total	6/18 (33.3%)
General disorders
Colonoscopy with polyp removal	1/18 (5.6%)	1
Infections and infestations
Sinusitis	2/18 (11.1%)	3
Body rash	1/18 (5.6%)	1
Musculoskeletal and connective tissue disorders
Orthopedic injury or surgery	2/18 (11.1%)	6
Dental treatments	2/18 (11.1%)	3
Respiratory, thoracic and mediastinal disorders
Bulb on nostril with diminished airflow	1/18 (5.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI/Institution will provide Sponsor with a copy of any proposed manuscripts or other material for publication thirty (30) days prior to publication for review and comment. Sponsor's comments shall be given due consideration by PI/Institution. Publication may be delayed at Sponsor's written request for a period not to exceed sixty (60) days if it contains a disclosure of an invention(s) on which either party desires to file a patent.