ClariFix Cryoablation Clinical Study

This is a small, prospective, multicenter, single-arm, self-controlled interventional feasibility study to evaluation cryoablation in the nasal passage as a treatment for chronic rhinitis. The ClariFix device is FDA-cleared device with the intended use for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Inclusion criteria

• Subject is >21 years of age
• Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for >3 months (rTNSS rating of 2 or 3)
• Subject has signed IRB-approved informed consent form

Exclusion criteria

• Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
• Subject has a septal perforation
• Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
• Subject has had prior head or neck irradiation
• Subject has active or chronic nasal or sinus infection
• Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks
• Subject has a history of dry nose symptoms
• Subject is pregnant or lactating
• Subject is participating in another clinical research study
• Subject has an allergy or intolerance to anesthetic agent
• Subject is an active smoker or has been a smoker within the last 6 months
• Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk