[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580762":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":51,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":24,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":79,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"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},"Intelligent Pressure and Temperature-Controlled Ureteroscope System","ACTIVE_COMPARATOR","Participants in this arm will undergo surgery using the Intelligent Pressure and Temperature-Controlled Ureteroscope System, which monitors and adjusts intrarenal pressure and temperature in real-time to ensure safe and effective lithotripsy.",[13],"Device: Intelligent Pressure and Temperature-Controlled Ureteroscope System",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional Ureteroscope","Participants assigned to this arm will undergo surgery with a conventional ureteroscope. The procedure involves standard ureteroscopic lithotripsy without real-time pressure or temperature monitoring.",[18],"Device: Conventional Ureteroscope",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","RIRS procedure for upper ureteral or renal stone lithotripsy with Intelligent Pressure and Temperature-Controlled Ureteroscope System",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"RIRS procedure for upper ureteral or renal stone lithotripsy with conventional ureteroscope",[15],[29],{"name":30,"affiliation":5,"role":31},"Kewei Xu, MD, PhD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","+86-13632331628","xukewei@mail.sysu.edu.cn",[38],{"facility":39,"status":24,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Sun Yat-sen Memorial Hospital of Sun Yat-sen University","Guangzhou","Guangdong","510120","China","CN",{"type":46,"coordinates":47},"Point",[48,49],113.25,23.11667,{"lat":49,"lon":48},{"type":31,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Xu Kewei","Principal Investigator, Clinical Professor","100580762","an-intelligent-pressure-and-temperature-control-ureteral-soft-scope-system-for-treating-stones-with-infection-100580762",false,"NCT06841523","An Intelligent Pressure and Temperature Control Ureteral Soft Scope System for Treating Stones With Infection.","Intelligent Pressure and Temperature Control Ureteral Soft Scope System for the Treatment of Upper Ureteral Stones Complicated With Infection in the Kidney and Upper Ureter: a Multicenter Randomized Controlled Clinical Study","Inclusion Criteria:\n\n1. 18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;\n2. ASA I-III;\n3. Patients who have been confirmed by bilateral renal\u002Furinary tract CT to have upper ureteral or renal stones, single or multiple, with a cumulative maximum diameter of 10mm \\\u003C cumulative maximum diameter ≤ 20mm, and are planning to undergo ureteroscopic lithotripsy for stone removal;\n4. Confirmed urinary tract infection, indicated by positive urine leukocytes and nitrite, or positive urine culture, with appropriate antibiotic treatment administered preoperatively;\n5. 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 acute 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":65,"type":66},288,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to determine the efficacy and safety of a novel intelligent pressure and temperature-controlled ureteroscope system for treating renal and upper ureteral stones with concurrent infection. It will also assess its ability to reduce postoperative complications and improve stone clearance rates. The main questions it aims to answer are:\n\nDoes the intelligent system lower the complication rate and enhance stone clearance compared to standard ureteroscopy? What safety issues or medical problems do participants experience when using the intelligent system? Researchers will compare the intelligent pressure and temperature-controlled ureteroscope system to a standard ureteroscope to evaluate its effectiveness in treating renal and upper ureteral stones.\n\nParticipants will:\n\nUndergo surgery using either the intelligent system or a standard ureteroscope Be monitored for postoperative complications, stone clearance, and other relevant outcomes Participate in follow-up visits to assess recovery and treatment efficacy",[72,73],"Ureterolithiasis","Renal Calculi",[75,76,77,78],"Ureteral Stone","renal stone","Ureteroscopy","Upper urinary tract stones with concurrent infection","NOT_YET_RECRUITING","2025-03-04",{"date":82,"type":83},"2025-03-07","ACTUAL",{"date":85,"type":66},"2025-04-01",{"date":87,"type":66},"2028-04-01",{"name":5,"class":6},1]