Trials / Completed
CompletedNCT04614324
A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)
A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Aerin Medical · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.
Detailed description
Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® ARC Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® ARC Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RhinAer ARC Stylus | 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). |
Timeline
- Start date
- 2020-10-05
- Primary completion
- 2021-06-30
- Completion
- 2024-12-20
- First posted
- 2020-11-04
- Last updated
- 2025-08-28
- Results posted
- 2024-08-21
Locations
15 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04614324. Inclusion in this directory is not an endorsement.