Safety and Efficacy Study of the ClariFix Cryoablation Device in Patients with Chronic Rhinitis

Arrinex, Inc.0 sites30 target enrollmentMay 5, 2014

Overview

No summary available.

Registry

who.int

Start Date

May 5, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•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