ClariFix Rhinitis RCT

A prospective, multicenter, randomized, sham-controlled, single-blind (participants) study to demonstrate the superiority of treatment with the ClariFix cryotherapy device for reducing symptoms when compared with a sham treatment in patients with chronic rhinitis. The ClariFix device is a Class II FDA-cleared medical device that is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Inclusion criteria

• Be ≥21 years of age.
• Has been diagnosed with chronic nonallergic or allergic rhinitis.
• Have moderate to severe symptoms of rhinorrhea (individual reflective Total Nasal Symptoms Score [rTNSS] symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total rTNSS of 4 (out of 12) at baseline.
• Have an allergy test (by skin prick or intradermal testing or by validated in vitro tests for specific Immunoglobin E [IgE]) on file within 12 months of the baseline visit.
• Be an appropriate candidate for bilateral ClariFix treatment performed under local anesthesia.
• Be willing and able to comply with all study elements, as indicated by their written informed consent.
• Be willing and able to comply with all study elements and provide written consent.

Exclusion criteria

• Have clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
• Have had previous sinus or nasal surgery within 6 months of study enrollment.
• Have previously undergone cryotherapy or other surgical interventions for rhinitis.
• Have an active nasal or sinus infection.
• Have rhinitis symptoms that are primarily due to seasonal allergies.
• Have plans to (or otherwise anticipates the need to) undergo an ENT (ear, nose, throat) procedure concurrently or within 3 months after the study procedure.
• Is on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure (81 mg aspirin and herbal supplements are acceptable).
• Be unable to discontinue ipratropium bromide (IB) at least 14 days before baseline and through the 90-day follow-up visit.
• Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
• Have a history of rhinitis medicamentosa.
• Have had previous head and/or neck irradiation.
• Have an allergy or intolerance to local anesthetic agents.
• Have cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or open and/or infected wounds at or near the target tissue.
• Have a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data.
• Be participating in another clinical research study.