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

Arrinex, Inc.0 个研究点目标入组 30 人开始时间: 2014年5月5日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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
•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

发起方