Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-Term Study Subjects | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Stylus | Device | Low power radiofrequency energy delivered to the posterior nasal nerve area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline rTNSS | 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. | 24 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Subjects who completed the 52-week follow-up visit of Aerin Study TP668 and consent to provide long-term quality of life and symptom information.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Wolf, MD | Aerin Medical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado ENT and Allergy | Colorado Springs | Colorado | 80909 | United States | ||
| Advanced ENT and Allergy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| New Albany |
| Indiana |
| 47150 |
| United States |
| Piedmont ENT Associates | Winston-Salem | North Carolina | 27103 | United States |
| Fort Worth ENT | Fort Worth | Texas | 76109 | United States |
| ENT and Allergy Associates of Texas | McKinney | Texas | 75070 | United States |