[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594888":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":132,"collaborators":19,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":19,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":19,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":38,"whyStopped":19,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Smith & Nephew, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"REFLEX ULTRA 45","EXPERIMENTAL","The investigational product REFLEX ULTRA 45 includes two models which are EIC4845-01 and EICA4845-01. The only difference between these two models is the EICA4845-01 has a maximum two-use limit.",[13],"Device: REFLEX ULTRA 45",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","One time use for surgery",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Dongdong Zhu","China-Japan Union Hospital, Jilin University","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Cathy Xiao","CONTACT","+86 18221637315","Cathy.xiao@smith-nephew.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Julian Yang","+86 18101802151","Julian.yang@smith-nephew.com",[36,56,68,85,101,116],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital, Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510080","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51,55],{"name":52,"role":28,"phone":53,"phoneExt":19,"email":54},"Jian Li","020-87608412","lijian7@mail.sysu.edu.cn",{"name":52,"role":24,"phone":19,"phoneExt":19,"email":19},{"facility":57,"status":38,"city":39,"state":40,"zip":58,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"The Third Affiliated Hospital, Sun Yat-sen University","510630",{"type":45,"coordinates":60},[47,48],{"lat":48,"lon":47},[63,67],{"name":64,"role":28,"phone":65,"phoneExt":19,"email":66},"Ointai Yang","020-85252131","yangqint@mail.sysu.edu.cn",{"name":64,"role":24,"phone":19,"phoneExt":19,"email":19},{"facility":69,"status":38,"city":70,"state":71,"zip":72,"country":42,"countryCode":43,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Henan Provincial People's Hospital","Zhengzhou","Henan","462000",{"type":45,"coordinates":74},[75,76],113.64861,34.75778,{"lat":76,"lon":75},[79,81,84],{"name":80,"role":28,"phone":19,"phoneExt":19,"email":19},"Guangke Wang",{"name":19,"role":28,"phone":82,"phoneExt":19,"email":83},"0371-87160070","13598895398@163.com",{"name":80,"role":24,"phone":19,"phoneExt":19,"email":19},{"facility":86,"status":38,"city":87,"state":88,"zip":89,"country":42,"countryCode":43,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Jiangsu Province Hospital","Nanjing","Jiangsu","210003",{"type":45,"coordinates":91},[92,93],118.77778,32.06167,{"lat":93,"lon":92},[96,100],{"name":97,"role":28,"phone":98,"phoneExt":19,"email":99},"Lei Cheng","025-68303974","chenglei@jsph.org.cn",{"name":97,"role":24,"phone":19,"phoneExt":19,"email":19},{"facility":102,"status":38,"city":103,"state":104,"zip":105,"country":42,"countryCode":43,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"China-Japan Union Hospital of Jilin University","Changchun","Jilin","130033",{"type":45,"coordinates":107},[108,109],125.32278,43.88,{"lat":109,"lon":108},[112,115],{"name":22,"role":28,"phone":113,"phoneExt":19,"email":114},"0431-89876991","zhudd@jlu.edu.cn",{"name":22,"role":24,"phone":19,"phoneExt":19,"email":19},{"facility":117,"status":38,"city":118,"state":119,"zip":120,"country":42,"countryCode":43,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine","Hangzhou","Zhejiang","310016",{"type":45,"coordinates":122},[123,124],120.16142,30.29365,{"lat":124,"lon":123},[127,131],{"name":128,"role":28,"phone":129,"phoneExt":19,"email":130},"Mang Xiao","0571-86006065","Joelxm@zju.edu.cn",{"name":128,"role":24,"phone":19,"phoneExt":19,"email":19},{"type":133,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":145,"type":146},105,"ESTIMATED","INTERVENTIONAL",[149],"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.",[152],"Nasal Obstruction Due to Inferior Turbinate Hypertrophy",[154,155,156,157,158],"REFLEX","CITR","ITH","Coblation Inferior Turbinate Reduction","Inferior Turbinate Hypertrophy","2026-01-05",{"date":161,"type":162},"2026-01-07","ACTUAL",{"date":164,"type":162},"2025-07-02",{"date":166,"type":146},"2028-06-30",{"name":5,"class":6},6]