Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
NCT ID: NCT02914236
Last Updated: 2019-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-09-27
2017-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vivaer Stylus
Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area
Vivaer Stylus
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Interventions
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Vivaer Stylus
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
75 Years
ALL
No
Sponsors
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Aerin Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Wolf, MD
Role: STUDY_DIRECTOR
Aerin Medical
Ofer Jacobowitz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital, New York, NY
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TP258
Identifier Type: -
Identifier Source: org_study_id
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