At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis
In Brief
A clinical study evaluating RhinAer ARC Stylus for Chronic Rhinitis. Completed, enrolled 129 participants across 15 sites in 2 countries.
Detailed Summary
Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.
Study Details
Timeline
Interventions
The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG815), which is a cleared (FDA - K192471) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. RhinAer has CE Marking in EU. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy was cleared for use in the US (FDA - K162810) and has CE Marking in the EU (CE639608).