[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567382":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":10,"responsibleParty":39,"collaborators":10,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":10,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":10,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"sTFL + Flexible Negative-Pressure UAS",null,"Under general anesthesia, a guidewire is first inserted. Then, the Flexible Negative Pressure UAS is inserted along the guidewire to the stone site. A ureteroscope is inserted through the sheath to the stone site. The sTFL is used to fragment the stone with a power setting of 0.8J and a frequency of 12 - 20Hz. Simultaneously, the fragmented stones are removed by negative pressure suction.",[13],"Device: Super Pulsed Thulium Fiber Laser (sTFL) + Flexible Negative Pressure Ureteral Access Sheath (UAS) Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"sTFL + Conventional UAS","Under general anesthesia, the Conventional UAS is inserted to the upper ureter or the ureteropelvic junction. A ureteroscope is inserted through the sheath to the stone site. The sTFT is used to fragment the stone with a power setting of 0.8J and a frequency of 12 - 20Hz. After fragmentation, the stones are removed by a stone basket.",[18],"Device: Super Pulsed Thulium Fiber Laser (sTFL) + Conventional Ureteral Access Sheath (UAS) Intervention",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Super Pulsed Thulium Fiber Laser (sTFL) + Flexible Negative Pressure Ureteral Access Sheath (UAS) Intervention","The intervention combines a Super Pulsed Thulium Fiber Laser (sTFL) with a power setting of 0.8J and a frequency of 12 - 20Hz for stone fragmentation and a Flexible Negative Pressure Ureteral Access Sheath (UAS) that allows access to the stone site and enables negative pressure suction for stone removal.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Super Pulsed Thulium Fiber Laser (sTFL) + Conventional Ureteral Access Sheath (UAS) Intervention","The intervention combines a Super Pulsed Thulium Fiber Laser (sTFL) with a power setting of 0.8J and a frequency of 12 - 20Hz for stone fragmentation and a Conventional Ureteral Access Sheath (UAS) used for access to the upper ureter or ureteropelvic junction for stone treatment.",[15],[30],{"name":31,"affiliation":5,"role":32},"Yi Shao","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Ruixuan Zhu","CONTACT","+86 13780820139","luluzhu2023@qq.com",{"type":32,"investigatorFullName":31,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Director","100567382","new-laser-and-suction-sheath-for-kidney-stone-treatment-100567382",false,"NCT06667466","New Laser and Suction Sheath for Kidney Stone Treatment","Prospective, Multicenter, Randomized Controlled Trial of Super Pulse Thulium Fiber Laser Combined With Flexible Negative Pressure Suction Sheath Versus Conventional Sheath for the Treatment of Kidney Stones","Inclusion Criteria:\n\n* Age ≥18 years old.\n* Diagnosed with kidney stones and\u002For ureteral stones, and stone diameter is ≥6mm and ≤20mm\n* Plan to undergo fURS lithotripsy\n* General anesthesia to complete the operation\n* The latest urine culture before surgery is negative\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Isolated kidney\n* Previous history of kidney transplantation or urinary diversion surgery\n* Congenital malformations of urinary system\n* Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc\n* Severe heart or lung disease, malignancy and immune deficiency status\n* Neurogenic bladder\n* Failure to provide informed consent\n* Have an untreated urinary tract infection\n* The presence of known anatomic abnormalities (such as ureteral stenosis), urothelial tumors, or stones that can be removed directly without the use of laser lithotripsy\n* Pregnant women\n* In cases where the stone cannot be reached with a bendable negative pressure suction sheath, or in cases where the stone cannot be reached with a conventional sheath or the pyeloureteral junction\n* Epidural anesthesia or lumbar anesthesia to complete the operation","ALL","18 Years","70 Years",{"count":52,"type":53},140,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to learn if the combination of super pulsed thulium fiber laser (sTFL) with a flexible negative pressure suction sheath is more effective and safer than sTFL with a conventional sheath in treating kidney stones and\u002For ureteral stones. The main questions it aims to answer are:\n\nDoes the sTFL with a flexible negative pressure suction sheath have a higher stone - free rate than the sTFL with a conventional sheath? Does the sTFL with a flexible negative pressure suction sheath have fewer complications than the sTFL with a conventional sheath?\n\nResearchers will compare the two treatment groups to see if there are differences in stone - free rate and complication rates.\n\nParticipants will:\n\nUndergo ureteroscopic lithotripsy surgery. In the experimental group, have a flexible negative pressure suction sheath inserted along a guidewire to the stone site under general anesthesia, then have a ureteroscope inserted through the sheath to the stone site, and have the stone fragmented by sTFL with a power setting of 0.8J and a frequency of 12 - 20Hz while the fragments are removed by negative pressure suction.\n\nIn the control group, have a conventional sheath inserted to the upper ureter or the ureteropelvic junction under general anesthesia, then have a ureteroscope inserted through the sheath to the stone site, and have the stone fragmented by sTFL with a power setting of 0.8J and a frequency of 12 - 20Hz and the fragments removed by a stone basket.",[57,58],"Kidney Calculi","Ureteral Calculi","NOT_YET_RECRUITING","2026-01-18",{"date":62,"type":63},"2026-01-21","ACTUAL",{"date":65,"type":53},"2026-11-20",{"date":67,"type":53},"2027-11-20",{"name":5,"class":6}]