Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
NCT ID: NCT04277507
Last Updated: 2025-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2020-02-07
2024-10-11
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
2. Willing and able to provide informed consent
3. Willing and able to comply with the study protocol
4. Seeking treatment for nasal obstruction
5. NOSE score of ≥ 60 at Baseline
6. 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
2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
18 Years
ALL
No
Sponsors
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Aerin Medical
INDUSTRY
Responsible Party
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Locations
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Alabama Nasal and Sinus Center
Birmingham, Alabama, United States
Arizona Desert ENT Specialists
Goodyear, Arizona, United States
Sacramento ENT
Roseville, California, United States
ENT Associates of South Florida
Boca Raton, Florida, United States
ENT Associates of South Florida
Plantation, Florida, United States
Chicago Nasal and Sinus Center
Chicago, Illinois, United States
Baton Rouge General / Sinus and Nasal Specialists of Louisiana
Baton Rouge, Louisiana, United States
Advocare Aroesty ENT Associates
Mount Arlington, New Jersey, United States
UT Physicians Otorhinolaryngology - Texas Medical Center
Houston, Texas, United States
ENT Associates of Texas
McKinney, Texas, United States
Countries
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References
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Yao WC, Pritikin J, Sillers MJ, Barham HP. Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction. Laryngoscope Investig Otolaryngol. 2023 Jun 15;8(4):808-815. doi: 10.1002/lio2.1089. eCollection 2023 Aug.
Yao WC, Ow RA, Barham HP (2021) Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study. J Otolaryngol Rhinol 7:104. doi.org/10.23937/2572-4193.1510105
Yao WC, Ow R, Sillers MJ, Nachlas NE, Johnson CD, Ehmer D, Pritikin J, Barham HP. Three-Year Outcomes After Temperature-Controlled Radiofrequency Treatment of Nasal Airway Obstruction. OTO Open. 2025 Apr 7;9(2):e70111. doi: 10.1002/oto2.70111. eCollection 2025 Apr-Jun.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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TP900
Identifier Type: -
Identifier Source: org_study_id
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