Clinical trial NCT02914236: Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
Official title: A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Keywords: Nasal valve
Nasal airway obstruction
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in NOSE Score
timeFrame: Baseline, 26 weeks
Secondary outcomes:
measure: NOSE Responder Rate
timeFrame: Baseline, 26 weeks
measure: Percentage of Participants With Treatment-Related Adverse Events (Safety)
timeFrame: Baseline through 26 weeks
Other outcomes:
measure: Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale
timeFrame: Immediately after study procedure, 4-weeks
measure: Subject Satisfaction
timeFrame: 26 weeks
Locations:
city: Fresno
country: United States
facility: Central California Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: Oradell
country: United States
facility: ENT and Allergy Associates, LLP
state: New Jersey
city: Bayside
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: New Hyde Park
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: New York
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: Staten Island
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose and Throat Associates
state: North Carolina
city: McKinney
country: United States
facility: Ear, Nose and Throat Associates of Texas
state: Texas
Study officials:
affiliation: Aerin Medical
name: Scott Wolf, MD
role: STUDY_DIRECTOR
affiliation: Mount Sinai Hospital, New York, NY
name: Ofer Jacobowitz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: