Chronic Rhinitis
Conditions
Keywords
ENT, Chronic rhinitis, Allergic rhinitis, Non-allergic rhinitis
Brief 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.
Interventions
DEVICERhinAer 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).
Sponsors
Aerin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Active treatment for all subject enrolling prospectively.
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 22 to 85 years (inclusively). 2. Willing and able to provide informed consent. 3. Willing and able to comply with the patient-specific requirements outlined in the study protocol. 4. Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration 5. Willing to undergo the RhinAer procedure 6. Has a baseline rTNSS symptom score of ≥6 at time of screening 7. If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure). 8. Has been diagnosed with either allergic or non-allergic chronic rhinitis and meet the following criteria: * a. Allergic rhinitis: diagnosed with perennial (non-seasonal) allergic rhinitis and has demonstrated sensitization to specific allergens through skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the allergic nature of their rhinitis within the past 24 months. OR -b. Nonallergic rhinitis: diagnosed with nonallergic rhinitis with demonstration of a negative skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the nonallergic nature of their rhinitis within the past 24 months.
Exclusion criteria
1. Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits access to the posterior nasal nerve treatment area. 2. Has seasonal rhinitis symptoms. 3. Current or recent use of biologic therapy within past 3 months. 4. History of chronic epistaxis or has had episodes of significant nose bleeds in the past 3 months. 5. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure. 6. Known or suspected to be pregnant or is lactating. 7. Has any condition resulting in a predisposition to excessive bleeding (e.g., hereditary hemorrhagic telangiectasia \[HHT\]). 8. Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has a history of 'dry eye.' 9. Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation). 10. Has had a nasal or sinus surgical procedure in the past six (6) months. 11. Currently participating in another clinical research study or has participated in an interventional study within the past 3 months. 12. Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period 13. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patients | Baseline and 3 months post study procedure | Change from baseline in expression of type-2 inflammatory cytokine markers in nasal mucus samples at 3 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in cough and post-nasal drip symptoms | From baseline to 6 months post-procedure | Change from baseline in cough and postnasal drip symptoms at 3 and 6 months post-procedure |
| The change in nasal symptoms of chronic rhinitis | From baseline to 6 months post-procedure | 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. |
| Change in SNOT-22 score | From baseline to 6 months post-procedure | 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). |
| Evaluate the impact of the RhinAer treatment in subjects with migraine-related symptoms | From baseline to 6 months post-procedure | 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). |
| Evaluate medication usage in chronic rhinitis patients | From baseline to completion of study, an average of 6 months | 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. |
| Evaluate patient reported pain outcomes related to the study procedure | Completed following the study procedure during treatment visit | 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. |
Countries
United States
Outcome results
None listed