Phase
Condition
Common Cold
Allergy
Nasal Obstruction
Treatment
RhinAer Stylus
Clinical Study ID
Ages 22-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 thestudy protocol.
Presenting to the ENT office seeking evaluation and/or treatment for chronicrhinitis (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 theperioperative period (at least 3-day window pre- and post-procedure).
Has been diagnosed with either allergic or non-allergic chronic rhinitis and meetthe following criteria:
- a. Allergic rhinitis: diagnosed with perennial (non-seasonal) allergic rhinitisand has demonstrated sensitization to specific allergens through skin pricktesting, 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
Exclusion Criteria:
Anatomic obstructions in the nasal passage(s) that in the investigator's opinionlimits 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 thepast 3 months.
Known or suspected allergies or contraindications to the anesthetic agents and/orantibiotic 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 ahistory 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 aninterventional 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 predisposethe patient to poor wound healing, increased surgical risk, or poor compliance withthe requirements of the study.
Study Design
Study Description
Connect with a study center
Colorado ENT & Allergy
Colorado Springs, Colorado 80923
United StatesActive - Recruiting
University of Cincinnati
Cincinnati, Ohio 45267
United StatesActive - Recruiting
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