NCT06599736

A Study of RhinAer Stylus for Treating Chronic Rhinitis

Effect of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve on Inflammatory Biomarkers in Patients With Allergic and Nonallergic Chronic Rhinitis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Aerin Medical · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.

Detailed description

Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.

Conditions

• Chronic Rhinitis

Interventions

Type	Name	Description
DEVICE	RhinAer Stylus	The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG1393, CAT1394), which is a 510(k) cleared (FDA - K221907) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy is also cleared for use in the US (FDA - K162810).

Timeline

• Start date: 2024-10-03
• Primary completion: 2025-11-12
• Completion: 2026-03-01
• First posted: 2024-09-19
• Last updated: 2026-02-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study