Vivaer Procedure for Nasal Congestion
(SWELL Trial)
Trial Summary
What is the purpose of this trial?
This trial studies the use of the Vivaer Arc Stylus, a device that helps shrink swollen nasal tissues, in adults with nasal blockages caused by Septal Swell Bodies (SSB).
Will I have to stop taking my current medications?
You may need to stop taking anticoagulant medications (blood thinners) during the perioperative period, which is a 3-day window on either side of the procedure. If you regularly use oxymetazoline (Afrin) nasal decongestant or oral steroids, you may not be eligible for the trial.
What data supports the effectiveness of the Vivaer treatment for nasal congestion?
How does the Vivaer treatment for nasal congestion differ from other treatments?
The Vivaer treatment is unique because it uses a radiofrequency device to treat nasal obstruction by reshaping the nasal tissues, which can be done in an office setting under local anesthesia, offering a less invasive option with a shorter recovery time compared to traditional surgical methods.26789
Research Team
Anais Laborde
Principal Investigator
Aerin Medical
Eligibility Criteria
This trial is for adults aged 22 to 85 with nasal congestion, specifically due to swollen septal bodies. Participants must have a NOSE score of at least 55, indicating significant nasal blockage, and be able to stop blood thinners around the procedure. They should not have had recent nasal surgery or plan any within 3 months after this treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Vivaer procedure using the Vivaer ARC Stylus to treat Septal Swell Bodies in a single session
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of NOSE Scale score changes
Long-term Follow-up
Participants are monitored for device-related adverse events and long-term outcomes
Treatment Details
Interventions
- Vivaer Arc Stylus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aerin Medical
Lead Sponsor