The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)
NCT ID: NCT05099263
Last Updated: 2025-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2021-09-14
2024-10-16
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 Procedure
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will undergo bilateral treatment of the nasal airway in a single study procedure session. Each side of the nose will be treated as follows:
• Two (2) to six (6) nonoverlapping applications of RF energy are performed at the SSB per nostril.
The default treatment settings will be used for the study: temperature 60 C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (36 months).
Vivaer Arc Stylus
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal airway in a single study session.
Interventions
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Vivaer Arc Stylus
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal airway in a single study session.
Eligibility Criteria
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Inclusion Criteria
2. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
3. Baseline NOSE score ≥ 55.
4. Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%.
5. Reduction in size of the SSB after application of topical decongestant on a cotton plug directly to the SSB region.
6. Improvement in the symptoms of nasal obstruction after SSB decongestion suggesting that the SSB may play a role in nasal obstruction.
7. Willing and able to withhold anticoagulant medications during the perioperative period (3-day window on either side).
8. Willing and able to provide informed consent.
9. Willing and able to comply with the participant-specific requirements outlined in the study protocol.
Exclusion Criteria
2. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the participant's nasal obstruction symptoms and warranting surgical intervention.
3. Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
4. Known or suspected allergies or contraindications for any general or local anesthetic agents.
5. Known or suspected to be pregnant or is lactating.
6. Participating in another clinical research study.
7. Other medical conditions which in the opinion of the investigator would predispose the participant to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
8. Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids.
9. For sites participating in the CT substudy only: Active sinus condition (eg, significant sinus diseases, infection or polyp formation) identified by CT.
22 Years
85 Years
ALL
Yes
Sponsors
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Aerin Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Anais Laborde
Role: STUDY_DIRECTOR
Aerin Medical
Locations
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Colorado Otolaryngology Associates LLC
Colorado Springs, Colorado, United States
Chicago Nasal and Sinus Center
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
Mount Sinai
New York, New York, United States
Madison ENT
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Vanderbilt Asthma, Sinus & Allergy Program
Nashville, Tennessee, United States
Alamo ENT Associates
San Antonio, Texas, United States
Countries
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References
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Pritikin J, Silvers S, Rosenbloom J, Davis B, Signore AD, Sedaghat AR, Tajudeen BA, Schmale I, Lyons J, Corey J, Chandra R. Temperature-controlled radiofrequency device treatment of septal swell bodies for nasal airway obstruction: An open-label, single arm multicenter study. Int Forum Allergy Rhinol. 2023 Oct;13(10):1915-1925. doi: 10.1002/alr.23156. Epub 2023 Mar 27.
Pritikin J, Silvers S, Rosenbloom J, Davis B, Del Signore A, Sedaghat AR, Tajudeen BA, Schmale I, Chandra RK. Twenty-Four-Month Outcomes Following Temperature-Controlled Radiofrequency Treatment for Septal Swell Body Hypertrophy: An Open-Label, Single-Arm Multicenter Study. Int Forum Allergy Rhinol. 2025 Jun;15(6):651-654. doi: 10.1002/alr.23541. Epub 2025 Feb 12. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CTP1125
Identifier Type: -
Identifier Source: org_study_id
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