Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Nasal Obstruction Clinical Trial

Official title:

A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914236
• Other study ID #: TP258
• Status: Completed
• Phase: N/A
• Start date: September 27, 2016
• Est. completion date: August 18, 2017

Study information

• Verified date: May 2019
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 18, 2017
• Est. primary completion date: July 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Airway Obstruction
• Nasal Obstruction

Intervention

Device:
• Vivaer Stylus
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Locations

Country	Name	City	State
United States	ENT and Allergy Associates, LLP	Bayside	New York
United States	Colorado ENT and Allergy	Colorado Springs	Colorado
United States	Central California Clinical Research	Fresno	California
United States	Ear, Nose and Throat Associates of Texas	McKinney	Texas
United States	ENT and Allergy Associates, LLP	New Hyde Park	New York
United States	ENT and Allergy Associates, LLP	New York	New York
United States	ENT and Allergy Associates, LLP	Oradell	New Jersey
United States	ENT and Allergy Associates, LLP	Staten Island	New York
United States	Piedmont Ear, Nose and Throat Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aerin Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale	Procedure-related pain as reported by the subject using a 100mm Visual Analog Scale (VAS), immediately post-procedure and at the 4-week follow-up visit. Higher scores indicate more severe pain.; The Pain VAS is presented to the subject as a 100mm line anchored on each end by verbal descriptors: 0 = no pain and 100 = worse pain imaginable. The distance between 0 and the vertical mark made by the subject is measured and the result is expressed in millimeters.	Immediately after study procedure, 4-weeks
Other	Subject Satisfaction	Study-specific survey to assess patient satisfaction with the discomfort of the procedure and recovery period, as well as their perceived results. The survey included 5 questions related to tolerability of the procedure, ease of recovery, change in breathing, satisfaction with treatment, and willingness to recommend treatment. Each question was scored on a 10-point scale, with 1 indicating the most negative response to the question (e.g., "very bad", "much worse", or "very dissatisfied") and 10 indicating the most favorable rating (e.g., "hardly noticeable", "much better", or "very satisfied"). Each question was individually scored and reported.	26 weeks
Primary	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	NOSE Responder Rate	Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment.	Baseline, 26 weeks
Secondary	Percentage of Participants With Treatment-Related Adverse Events (Safety)	Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.	Baseline through 26 weeks