A Study of RhinAer Stylus for Treating Chronic Rhinitis

Running, not enrolling · Not applicable

Conditions studied: Chronic Rhinitis

In brief

Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.

Key facts

Study ID

NCT06599736

Run by

Aerin Medical

People needed

25

Starts

2024-10-03

Expected to finish

2026-03-01

Last updated by the study team

2026-02-12

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 22 to 85 years (inclusively).
• Willing and able to provide informed consent.
• Willing and able to comply with the patient-specific requirements outlined in the study protocol.
• Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration
• Willing to undergo the RhinAer procedure
• Has a baseline rTNSS symptom score of ≥6 at time of screening
• If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure).
• 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.

You may not qualify if…

• Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits access to the posterior nasal nerve treatment area.
• Has seasonal rhinitis symptoms.
• Current or recent use of biologic therapy within past 3 months.
• History of chronic epistaxis or has had episodes of significant nose bleeds in the past 3 months.
• Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure.
• Known or suspected to be pregnant or is lactating.
• Has any condition resulting in a predisposition to excessive bleeding (e.g., hereditary hemorrhagic telangiectasia [HHT]).
• Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has a history of 'dry eye.'
• Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation).
• Has had a nasal or sinus surgical procedure in the past six (6) months.
• Currently participating in another clinical research study or has participated in an interventional study within the past 3 months.
• Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period
• 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 it is running

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

Full record on ClinicalTrials.gov

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