[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nasal-obstruction-due-to-inferior-turbinate-hypertrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nasal-obstruction-due-to-inferior-turbinate-hypertrophy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100594888","post-market-clinical-study-to-evaluate-the-safety-and-effectiveness-of-reflex-ultra-45-for-coblation-inferior-turbinate-reduction-in-china-100594888",false,"NCT07025304","Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China","A Prospective, Multi-center, Post-Market Clinical Study to Evaluate the Safety and Effectiveness of the REFLEX ULTRA 45 for the Coblation Inferior Turbinate Reduction in China","Inclusion Criteria:\n\n* Subject with at least two-year history of perennial rhinitis and who has failed one month of continuous standardized treatment with hormonal nasal spray by the date of surgery.\n* Subject with nasal obstruction due to turbinate hypertrophy and is suitable to receive coblation inferior turbinate reduction for bilateral nasal cavity without outfracture of inferior turbinate per the investigator's judgement.\n* Subject is 18 - 65 years old (inclusive).\n* Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) approved consent form before any study procedures are performed, including pre- operative data review and\u002For collection of data on electronic Case Report Forms (eCRFs).\n* Subject is willing and able to participate in required follow-up visits and is able to complete study activities.\n\nExclusion Criteria:\n\n* Subject who does not meet the indication or is contraindicated according to specific REFLEX ULTRA 45 's Instructions for Use (IFUs).\n* Subject with obvious deviation of nasal septum with the necessity of surgery under investigator's judgement.\n* Participation in the treatment period of another clinical trial within thirty (30) days of all visits completed.\n* Subject who needs other nasal surgery other than single inferior turbinate reduction evaluated by MRI and nasal endoscopy.\n* Subject who has nasal obstruction due to inferior turbinate bony hypertrophy.\n* Subject who was treated with inferior turbinate reduction before informed consent.\n* Subjects who completed the Zung Self-Rating Anxiety Scale and the anxiety rate is more than 59.\n* Woman who is pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.\n* Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.\n* Subject who has participated previously in this clinical trial or who has been withdrawn.\n* Subject with a history of poor compliance with medical treatment.\n* Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.","ALL","18 Years","65 Years",{"count":20,"type":21},105,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study is a prospective, multi-center, post-market clinical study to evaluate the safety and effectiveness of REFLEX ULTRA 45 for the coblation inferior turbinate reduction in China. The study product is REFLEX ULTRA 45 (EIC4845-01\u002FEICA4845-01). Also it needs to be performed with the controller system COBLATOR II or WEREWOLF. The sample size is 105 subjects with approximate 6 sites in China mainland.",[27],"Nasal Obstruction Due to Inferior Turbinate Hypertrophy",[29,30,31,32,33],"REFLEX","CITR","ITH","Coblation Inferior Turbinate Reduction","Inferior Turbinate Hypertrophy","RECRUITING","2026-01-05",{"date":37,"type":38},"2026-01-07","ACTUAL",{"date":40,"type":38},"2025-07-02",{"date":42,"type":21},"2028-06-30",{"name":44,"class":45},"Smith & Nephew, Inc.","INDUSTRY",6]