None listed
Conditions
Brief summary
Prior studies have shown that cryoablation in the nose improves nasal symptoms in patients with chronic rhinitis. This study is a prospective, non-randomized clinical study to assess the safety and effectiveness of the ClariFix Cryoablation Device when used to ablate unwanted tissue in the nose of patients with chronic rhinitis.
Interventions
The intervention consists of cryoablation in the nasal passageway using a new cryosurgical device called the ClariFix Device. The ClariFix Device circulates liquid nitrous oxide through a closed-tip cryoprobe, where it is allowed to expand through a fine annular space. The transformation of the liquid into gas extracts heat from the surrounding areas by the Joule-Thompson effect. Either one or two treatments are delivered in each nasal cavity under endoscopic visualization, for a total of two to
The intervention consists of cryoablation in the nasal passageway using a new cryosurgical device called the ClariFix Device. The ClariFix Device circulates liquid nitrous oxide through a closed-tip cryoprobe, where it is allowed to expand through a fine annular space. The transformation of the liquid into gas extracts heat from the surrounding areas by the Joule-Thompson effect. Either one or two treatments are delivered in each nasal cavity under endoscopic visualization, for a total of two to four treatments per patient. The treatment is delivered under local anesthesia. The total procedure time is approximately 30 minutes. The study procedure is performed only once per patient; there are no repeat procedures.
Sponsors
Arrinex, Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Subject is >18 years of age b) Subject has had moderate to severe symptoms of rhinorrhea and nasal congestion for >6 months (rTNSS rating of 2 or 3 for rhinorrhea and congestion) c) Subject has signed EC-approved informed consent form
Exclusion criteria
a) Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor b) Subject has a septal perforation c) Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose d) Subject has had prior head or neck irradiation e) Subject has active or chronic nasal or sinus infection f) Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks g) Subject has a history of dry eye or dry nose symptoms h) Subject is pregnant i) Subject is participating in another clinical research study j) Subject has an allergy or intolerance to anesthetic agent k) Subject is an active smoker or has been a smoker within the last 6 months l) Any physical condition that in the investigator’s opinion would prevent adequate study participation or pose increased risk
Outcome results
None listed