Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device
- Conditions
- Chronic Rhinitis
- Interventions
- Device: Radiofrequency Stylus
- Registration Number
- NCT04684875
- Lead Sponsor
- Aerin Medical
- Brief Summary
Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus
- Detailed Description
This is a prospective, non-randomized, multicenter follow-up study to collect long-term data on a cohort of patients who participated in the Aerin Medical TP668 study, "Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis". The study will be conducted in a maximum of 5 centers that participated and enrolled patients in the TP668 study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Received treatment for chronic rhinitis in Aerin Study TP668
- Unwilling to participate in this long-term study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Long-Term Study Subjects Radiofrequency Stylus All subjects who were treated with the Aerin Medical InSeca/RhinAer Stylus in the 50-subject TP668 interventional study, who consent to continue to provide quality of life data.
- Primary Outcome Measures
Name Time Method Change from Baseline rTNSS 24 months Mean change in reflective Total Nasal Symptom Score (rTNSS) from baseline. The TNSS is an instrument used to collect patient self-rated severity of rhinorrhea, nasal congestion, nasal itching and sneezing. In this study, a reflective score will be collected, in which the subject will be asked to evaluate symptom severity over the preceding 12 hours. Symptom severity is rated on a 4-point scale of 0 (absent symptoms), 1 (mild symptoms), 2 (moderate symptoms, or 3 (severe symptoms), with the total score therefore ranging from 0 to 12. A negative change reported for the change from baseline indicates an improved outcome.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Colorado ENT and Allergy
🇺🇸Colorado Springs, Colorado, United States
Advanced ENT and Allergy
🇺🇸New Albany, Indiana, United States
Piedmont ENT Associates
🇺🇸Winston-Salem, North Carolina, United States
ENT and Allergy Associates of Texas
🇺🇸McKinney, Texas, United States
Fort Worth ENT
🇺🇸Fort Worth, Texas, United States