[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593938":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":53,"collaborators":56,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":25,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":25,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":106,"whyStopped":25,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Superpulse Thulium Fiber laser (SPTFL)","ACTIVE_COMPARATOR","With the help of a Superpuled Thulium Fibre laser machine, the ureteral or renal stones that are going to be treated with the RIRS procedure are either fragmented or dusted as part of the procedure.",[13],"Device: Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone",{"label":15,"type":10,"description":16,"interventionNames":17},"Holmium: YAG laser","With the help of a Holmium fibre laser machine, the ureteral or renal stones that are going to be treated with the RIRS procedure are either fragmented or dusted as part of the procedure.",[18],"Device: Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone","RIRS procedure for upper ureteral or renal stone lithotripsy with Superpulsed Thulium Laser",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone","RIRS procedure for upper ureteral or renal stone lithotripsy with Holmium: YAG Laser",[15],[31],{"name":32,"affiliation":5,"role":33},"Kewei Xu, MD, PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+86-13632331628","xukewei@mail.sysu.edu.cn",[40],{"facility":41,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":25},"Sun Yat sen Memorial Hospital of Sun Yat sen University","Guangzhou","Guangdong","510120","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},{"type":33,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Xu Kewei","Kewei Xu, MD, Ph.D",[57,59,61,63,65,67,69,71,73,75,77],{"name":58,"class":6},"RenJi Hospital",{"name":60,"class":6},"Tongji Hospital",{"name":62,"class":6},"West China Hospital",{"name":64,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"name":66,"class":6},"Renmin Hospital of Wuhan University",{"name":68,"class":6},"Beijing Friendship Hospital",{"name":70,"class":6},"Second Affiliated Hospital of Guangzhou Medical University",{"name":72,"class":6},"Beijing Tsinghua Changgeng Hospital",{"name":74,"class":6},"People's Hospital of Guangxi Zhuang Autonomous Region",{"name":76,"class":6},"Peking University Shenzhen Hospital",{"name":78,"class":6},"Shenzhen People's Hospital","100593938","super-pulsed-thulium-fiber-laser-versus-holmiumyag-laser-in-retrograde-intrarenal-surgery-for-upper-ureteral-and-renal-stones-100593938",false,"NCT07012941","Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureteral and Renal Stones","An Application of Super-pulsed TFL vs Ho:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureter and Renal Stones: A Multi-center Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n1. 18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;\n2. Patients who have been confirmed by bilateral renal\u002Furinary tract CT to have upper ureteral or renal stones, single or multiple, and are planning to undergo ureteroscopic lithotripsy for stone removal;\n3. Confirmed by bilateral renal\u002Furinary tract CT, the cumulative maximum diameter of stones is 10mm\\\u003Ccumulative maximum diameter ≤ 25mm;\n4. Those who voluntarily participate and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Uncontrollable systemic hemorrhagic disease;\n2. Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;\n3. Uncontrolled urinary tract infections;\n4. Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;\n5. Pregnant, planned pregnancy within 3 months, and lactating female patients;\n6. The patients determined by the investigator to be unsuitable for this study include (but are not limited to): known to have human immunodeficiency virus (HIV) or AIDS; Suffering from mental illness; Infectious diseases;","ALL","18 Years","75 Years",{"count":90,"type":91},448,"ESTIMATED","INTERVENTIONAL",[94],"NA","The holmium laser is currently considered the gold standard for lithotripsy on urinary lithiasis, whereas the super-pulsed thulium fibre laser is a relatively new technology. Through a multi-center prospective randomised clinical study that mainly aims to explore the effectiveness and safety of a super-pulsed fibre thulium laser compared to a holmium laser in the treatment of upper ureteral and renal stones (10mm\\\u003Ccumulative maximum diameter ≤ 25mm) in retrograde intrarenal surgery. The research participants are assigned randomly to undergo retrograde intrarenal surgery (RIRS) either using a super-pulsed thulium fibre laser or a holmium-YAG laser with an allocation ratio of 1:1. The secondary aim of this study is to provide high-level evidence for the development of diagnostic and treatment guidelines in the field of urolithiasis, both domestically and internationally. The outcomes of the RIRS procedures are compared for the two treatment arms.",[97,98],"Ureterolithiasis","Renal Calculi",[100,101,102,103,104,105],"Super pulse thulium fiber laser (SPTFL)","Ho:YAG laser","Lithotripsy","Ureteral Stone","Ureteroscopy","renal stone","NOT_YET_RECRUITING","2025-06-09",{"date":109,"type":110},"2025-06-10","ACTUAL",{"date":112,"type":91},"2025-07-01",{"date":114,"type":91},"2027-03-20",{"name":5,"class":6},1]