The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)

Completed · Not applicable

Conditions studied: Nasal Obstruction

In brief

Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).

Key facts

Study ID

NCT05099263

Run by

Aerin Medical

People needed

70

Starts

2021-09-14

Expected to finish

2024-10-16

Last updated by the study team

2025-08-28

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 22 to 85 years (inclusively).
• Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
• Baseline NOSE score ≥ 55.
• Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%.
• Reduction in size of the SSB after application of topical decongestant on a cotton plug directly to the SSB region.
• Improvement in the symptoms of nasal obstruction after SSB decongestion suggesting that the SSB may play a role in nasal obstruction.
• Willing and able to withhold anticoagulant medications during the perioperative period (3-day window on either side).
• Willing and able to provide informed consent.
• Willing and able to comply with the participant-specific requirements outlined in the study protocol.

You may not qualify if…

• Rhinoplasty, septoplasty, inferior turbinate (IT) reduction, or other surgical nasal procedures within the preceding 6 months.
• 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.
• Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
• Known or suspected allergies or contraindications for any general or local anesthetic agents.
• Known or suspected to be pregnant or is lactating.
• Participating in another clinical research study.
• 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.
• Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids.
• For sites participating in the CT substudy only: Active sinus condition (eg, significant sinus diseases, infection or polyp formation) identified by CT.

Where it is running

• 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

Full record on ClinicalTrials.gov

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