Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Completed · Not applicable

Conditions studied: Nasal Obstruction

In brief

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

Key facts

Study ID

NCT02914236

Run by

Aerin Medical

People needed

50

Starts

2016-09-27

Expected to finish

2017-08-18

Last updated by the study team

2019-05-21

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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