At a glance
ClinicalIndex Comparison RecordN/ACompleted· 70 enrolled
Drug / intervention
Vivaer Arc Stylusdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Vivaer Procedure for Treatment of the Septal Swell Bodies for Airway Obstruction - A Prospective Open-Label Multicenter Study (SWELL)
In Brief
A clinical study evaluating Vivaer Arc Stylus for Nasal Obstruction. Completed, enrolled 70 participants across 9 sites.
Detailed Summary
Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Obstruction
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartSep 2021
First PostedOct 2021
Primary CompletionApr 2022
Study CompletionOct 2024
TodayJul 2026
First PostedOct 29, 2021
Enrollment StartSep 14, 2021
Primary CompletionApr 27, 2022
Study CompletionOct 16, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.7 years ago
Interventions
Vivaer Arc Stylusdevice
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.