Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device

Aerin Medical45 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Rhinitis

Interventions

Radiofrequency StylusDEVICE

Low power radiofrequency energy delivered to the posterior nasal nerve area

Eligibility

Sex: ALLMin age: 22 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Received treatment for chronic rhinitis in Aerin Study TP668 Exclusion Criteria: * Unwilling to participate in this long-term study

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

Fort Worth ENT

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Data from ClinicalTrials.gov

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