Treatment of Nasal Airway Obstruction Using the Aerin Medical Device (NCT02914236) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
United States50 participantsStarted 2016-09-27
Plain-language summary
Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.
Who can participate
Age range22 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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