NCT05099263

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

The Vivaer Procedure for Treatment of the Septal Swell Bodies for Airway Obstruction - A Prospective Open-Label Multicenter Study (SWELL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Aerin Medical · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Prospective, Open-Label, Multicenter, Single Arm Study of the Aerin Medical Vivaer ARC Stylus to treat Septal Swell Bodies (SSB) to improve symptoms in adults diagnosed with nasal obstruction attributed to SSB.

Conditions

• Nasal Obstruction

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-09-14
• Primary completion: 2022-04-27
• Completion: 2024-10-16
• First posted: 2021-10-29
• Last updated: 2025-08-28
• Results posted: 2024-08-21

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study