Brief Summary

Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Sep 2016

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

September 22, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed

1 day until next milestone

Study Start

First participant enrolled

September 27, 2016

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2017

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed

7 months until next milestone

Results Posted

Study results publicly available

March 6, 2018

Completed

Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

September 22, 2016

Results QC Date

January 8, 2018

Last Update Submit

May 14, 2019

Conditions

Nasal Obstruction

Keywords

Nasal valveNasal airway obstruction

Outcome Measures

Primary Outcomes (1)

Improvement in NOSE Score
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive 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, 26 weeks

Secondary Outcomes (2)

NOSE Responder Rate
Baseline, 26 weeks
Percentage of Participants With Treatment-Related Adverse Events (Safety)
Baseline through 26 weeks

Other Outcomes (2)

Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale
Immediately after study procedure, 4-weeks
Subject Satisfaction
26 weeks

Study Arms (1)

Vivaer Stylus

EXPERIMENTAL

Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area

Device: Vivaer Stylus

Interventions

Vivaer StylusDEVICE

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

Also known as: Aerin Medical Device

Vivaer Stylus

Eligibility Criteria

Age22 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Seeking treatment for nasal obstruction and willing to undergo an office-based procedure
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 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 twelve (12) months
Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction
Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms
Known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications
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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Aerin Medicallead

Study Sites (9)

Central California Clinical Research

Fresno, California, 93720, United States

Location

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Location