Clinical trial NCT06599736: A Study of RhinAer Stylus for Treating Chronic Rhinitis
Official title: Effect of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve on Inflammatory Biomarkers in Patients With Allergic and Nonallergic Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Rhinitis
Keywords: ENT
Chronic rhinitis
Allergic rhinitis
Non-allergic rhinitis
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Active treatment for all subject enrolling prospectively.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patients
timeFrame: Baseline and 3 months post study procedure
Secondary outcomes:
measure: The change in cough and post-nasal drip symptoms
timeFrame: From baseline to 6 months post-procedure
measure: The change in nasal symptoms of chronic rhinitis
timeFrame: From baseline to 6 months post-procedure
measure: Change in SNOT-22 score
timeFrame: From baseline to 6 months post-procedure
measure: Evaluate the impact of the RhinAer treatment in subjects with migraine-related symptoms
timeFrame: From baseline to 6 months post-procedure
measure: Evaluate medication usage in chronic rhinitis patients
timeFrame: From baseline to completion of study, an average of 6 months
measure: Evaluate patient reported pain outcomes related to the study procedure
timeFrame: Completed following the study procedure during treatment visit
Other outcomes:
measure: Evaluate the occurrence of any device- or procedure-related adverse events
timeFrame: From baseline to completion of study, an average of 6 months
Locations:
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References: