Abstract / Summary
Abstract Objective The purpose of this registry was to capture observational data on a large and diverse cohort treated with the ClariFix Cryotherapy device for chronic rhinitis. Study Design Prospective, multicenter, nonrandomized, observational registry. Setting Twenty‐two tertiary care and private otolaryngology practices. Methods ClariFix treatment was administered to adult patients with allergic or nonallergic chronic rhinitis. Outcome measures included the reflective Total Nasal Symptom Score, mini Rhinoconjunctivitis Quality of Life Questionnaire, Patient Global Impression of Change, Clinician Global Impression‐Improvement, and adverse events related to the device or procedure through 24‐month follow‐up. Results A total of 354 participants received 932 treatments. The mean change in total reflective Total Nasal Symptom Score from baseline to all follow‐ups was significant ( P < .001); greater than 73% of participants were responders, achieving ≥1 point reduction at all follow‐ups. Participants with baseline reflective Total Nasal Symptom scores ≥ 7 had greater improvement than those with baseline scores < 7 ( P < .001). Greater than 74% of participants were quality of life responders (≥0.4 points) at all follow‐ups with the mini Rhinoconjunctivitis Quality of Life Questionnaire. More than 73% of participants reported PGIC improvement at all follow‐ups. Clinicians noted improvement in 87.1% of participants at 3‐month follow‐up. No device‐ or treatment‐related serious adverse events were reported. Device‐ and treatment‐related adverse events were transient, nonserious, and typically resolved by over‐the‐counter medication and warm beverages. Conclusion This registry provides additional long‐term evidence of the safety and efficacy of cryotherapy for the treatment of chronic rhinitis in a diverse population through 24 months.