Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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).
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
University of Cincinnati
Cincinnati, Ohio, United States
Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patients
Change from baseline in expression of type-2 inflammatory cytokine markers in nasal mucus samples at 3 months post-procedure
Time frame: Baseline and 3 months post study procedure
The change in cough and post-nasal drip symptoms
Change from baseline in cough and postnasal drip symptoms at 3 and 6 months post-procedure
Time frame: From baseline to 6 months post-procedure
The change in nasal symptoms of chronic rhinitis
Change from baseline in Reflective Total Nasal Symptom Score (rTNSS) total score at 3 and 6 months post-procedure. This is a 4 item questionnaire and each is scored from 0 (none) to 3 (severe), with a maximum score of 12. A higher number indicating more congestion.
Time frame: From baseline to 6 months post-procedure
Change in SNOT-22 score
Change from baseline in Sino-nasal Outcome Test (SNOT-22) score at 3 and 6 months post-procedure. The SNOT-22 contains 22 nose, sinus, and general health-related quality of life (HRQoL) items and is used to measure HRQoL associated with rhinosinusitis. Participants are required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be).
Time frame: From baseline to 6 months post-procedure
Evaluate the impact of the RhinAer treatment in subjects with migraine-related symptoms
Change from baseline in Headache Impact Test (HIT-6) score at 3 and 6 months post-procedure. The HIT-6 is an instrument used to measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress as well as severity of headache pain. The HIT-6 requires patients to answer six questions regarding their migraines, each question is scored on a 5-point Likert scale. The HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., Little or no impact (46 or less), Some impact (50 -55), Substantial impact (56-59) or Severe impact (60-78).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From baseline to 6 months post-procedure
Evaluate medication usage in chronic rhinitis patients
Change from baseline in medication usage at 3 months and 6 months post-procedure. Self-reported assessments of any change from baseline in frequency (including those taken as needed), dose, or change in route of administration of medications used to manage nasal symptoms related to chronic rhinitis, will be recorded. Assessment of medication use will be repeated at the time of procedure and at all subsequent follow-up timepoints, through completion of the study, an average of 6 months.
Time frame: From baseline to completion of study, an average of 6 months
Evaluate patient reported pain outcomes related to the study procedure
VAS will be completed by the patient immediately post-procedure. The Visual Analogue Scale (VAS) is a unidimensional measure of pain intensity that will be used to measure nasal pain associated with the procedure. A VAS is a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Scores are obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the patient to indicate their current level of pain in and around the nose. Results are then assigned a score between 0 and 100.
Time frame: Completed following the study procedure during treatment visit