This protocol was approved by Quorum Independent Review Board. Candidates for the study were adult patients with rhinorrhea with or without nasal congestion symptoms despite medical therapy >3 months. The study was performed across 3 sites: Sinus Center of the South Bay Area ENT; Texas Sinus Center; and San Francisco Otolaryngology. Patients who had persistent symptoms were screened with the reflective Total Nasal Symptom Score (TNSS). TNSS is a validated symptom severity scoring system that consists of the sum of 4 individual subject‐assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0 = none, 1 = mild, 2 = moderate, or 3 = severe. The reflective TNSS is a maximum 12‐point scale based on the subject's evaluation of symptom severity over the preceding 12 hours. Patients who had a minimum rhinorrhea and/or congestion subscore of 2 were eligible for the study. Patients were also screened with a diagnostic nasal endoscopy. Exclusion criteria included patient‐reported history of chronic rhinosinusitis, severe septal deviation precluding visualization of the middle meatus, endoscopic findings of polyps or purulence in the middle meatus, septal perforation, or prior sinus or nasal surgery that significantly altered the anatomy of the posterior nasal cavity. Upon entry to the study, patients completed the TNSS to assess symptoms of rhinorrhea, nasal congestion, nasal itching, and sneezing. Patient demographics and medical history were also recorded, including atopic status based on blood or skin test. Patients were asked to report their baseline medication use for treatment of rhinitis.
The intervention was performed in the office using a novel cryotherapy device called the ClariFix device. The device is a hand‐held, endoscopically placed cryoprobe through which nitrous oxide cryogen is delivered at the tip in a closed system (Fig.1 ).
The cryogen cartridge is inserted into the handle immediately prior to the procedure. The cryogen is released into the probe tip by the surgeon via a control dial. The device is designed for single‐patient use and is disposable.
The procedures were performed under local anesthesia in the office setting using topical anesthetic (4% tetracaine or 3% bupivacaine) or injected 1% lidocaine with 1:100,000 epinephrine, per surgeon's preference. After application of anesthesia, the tip of the cryodevice was applied endoscopically to the posterior middle meatus, and the surgeon then activated the cryogen to perform cryoablation of the mucosa in the region of the PNN (Fig.2 ). The cryogen cartridge was then changed and the contralateral side was treated in an identical fashion.
Patients then returned for follow‐up nasal endoscopy at 7, 30, and 90 days postprocedure. Additionally, patients were interviewed to assess nasal symptoms and side effects at 1, 7, 30, 90, 180, and 365 days.
A research assistant unaffiliated with the sponsor collected data at each site. Descriptive statistics were used to evaluate and summarize the data. Changes from baseline were evaluated using a paired t test examining the distribution of within‐patient changes from baseline for each of the follow‐up intervals. Statistical analysis was performed by an independent biostatistician funded by Arrinex.
The intervention was performed in the office using a novel cryotherapy device called the ClariFix device. The device is a hand‐held, endoscopically placed cryoprobe through which nitrous oxide cryogen is delivered at the tip in a closed system (Fig.
The cryogen cartridge is inserted into the handle immediately prior to the procedure. The cryogen is released into the probe tip by the surgeon via a control dial. The device is designed for single‐patient use and is disposable.
The procedures were performed under local anesthesia in the office setting using topical anesthetic (4% tetracaine or 3% bupivacaine) or injected 1% lidocaine with 1:100,000 epinephrine, per surgeon's preference. After application of anesthesia, the tip of the cryodevice was applied endoscopically to the posterior middle meatus, and the surgeon then activated the cryogen to perform cryoablation of the mucosa in the region of the PNN (Fig.
Patients then returned for follow‐up nasal endoscopy at 7, 30, and 90 days postprocedure. Additionally, patients were interviewed to assess nasal symptoms and side effects at 1, 7, 30, 90, 180, and 365 days.
A research assistant unaffiliated with the sponsor collected data at each site. Descriptive statistics were used to evaluate and summarize the data. Changes from baseline were evaluated using a paired t test examining the distribution of within‐patient changes from baseline for each of the follow‐up intervals. Statistical analysis was performed by an independent biostatistician funded by Arrinex.
