Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

Completed · Not applicable

Conditions studied: Chronic Rhinitis

In brief

A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.

Key facts

Study ID: NCT03181594
Run by: Arrinex, Inc.
People needed: 100
Starts: 2017-03-02
Expected to finish: 2020-04-06
Last updated by the study team: 2021-03-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is >21 years of age
Subject has moderate to severe symptoms of rhinorrhea (individual symptom rating of 2 or 3), mild to severe symptoms of congestion (individual symptom rating of 1, 2 or 3) and a minimum TNSS score of 4 (out of 12) at the time of the treatment visit, which have been present for > 6 months.
Subject has had documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens or is willing to have one performed prior to study exit.
Subject has been dissatisfied with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief by the subject's assessment.
Subject has signed IRB-approved informed consent form

You may not qualify if…

Subject has clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to septal deviation or perforation, nasal polyps, sinonasal tumor.
Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
Subject has active nasal or sinus infection.
Subject has moderate to severe ocular symptoms.
Subject has a history of nosebleeds in the past 3 months.
Subject has a history of rhinitis medicamentosa.
Subject has had prior head or neck irradiation
Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
Subject is pregnant.
Subject is participating in another clinical research study.
Subject has an allergy or intolerance to anesthetic agent.
Subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.

Where it is running

California Sleep Institute — East Palo Alto, California, United States
Sacramento Ear, Nose, and Throat — Sacramento, California, United States
San Francisco Otolaryngology Medical Group — San Francisco, California, United States
Ear, Nose, and Throat Associates of South Florida — Boca Raton, Florida, United States
Bethlehem Ear, Nose, and Throat — Bethlehem, Pennsylvania, United States
EVMS Otolaryngology — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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