Treatment for chronic rhinitis using the RhinAer Stylus

Effect of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve on Inflammatory Biomarkers in Patients With Allergic and Nonallergic Chronic Rhinitis

This study is testing if a new device called the RhinAer Stylus can help adults with chronic rhinitis feel better by targeting a specific area in the nose.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 22 Years to 85 Years
• Sex: All
• Sponsor: Aerin Medical (Industry-sponsored)
• Locations: 2 sites (Colorado Springs, Colorado and 1 other locations)
• Trial ID: NCT06599736 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the RhinAer Stylus in treating chronic rhinitis by targeting the posterior nasal nerve area. It is a prospective, open-label, multicenter study involving adults aged 22 to 85 who have been diagnosed with chronic rhinitis for at least 12 months. Participants will undergo the RhinAer procedure and their symptoms will be monitored, along with inflammatory biomarkers, to assess treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 85 with a diagnosis of chronic rhinitis, either allergic or non-allergic, who have experienced symptoms for at least 12 months.

Not a fit: Patients with acute rhinitis or those who do not meet the eligibility criteria, such as younger individuals or those with a symptom score below the threshold, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms of chronic rhinitis for patients.

How similar studies have performed: Other studies have shown promise in treating chronic rhinitis with similar approaches, indicating potential for success.

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.

Where this trial is running

Colorado Springs, Colorado and 1 other locations

• Colorado ENT & Allergy — Colorado Springs, Colorado, United States (Recruiting)
• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Tien Dang

Conditions Chronic Rhinitis; ENT; Chronic rhinitis; Allergic rhinitis; Non-allergic rhinitis