[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606915":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":27,"locations":24,"responsibleParty":33,"collaborators":24,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":9,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":24,"enrollmentInfo":44,"targetDuration":24,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":56,"overallStatus":63,"whyStopped":24,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":24},{"fullName":5,"class":6},"Ningbo No. 1 Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VISOR","EXPERIMENTAL","Surgery will be performed using the VISOR through a 14Fr UAS",[13],"Procedure: VISOR",{"label":15,"type":16,"description":17,"interventionNames":18},"fURS","ACTIVE_COMPARATOR","Surgery will be performed using a standard single-use electronic ureterorenoscope through a 14Fr UAS",[19],"Procedure: fURS",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"PROCEDURE",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Li Fang","CONTACT","+8617757461299","fanyuro@126.com",{"type":34,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100606915","clinical-trial-of-visor-vs-furs-for-upper-urinary-tract-stone-100606915",false,"NCT07181759","Clinical Trial of VISOR vs fURS for Upper Urinary Tract Stone","Prospective Randomized Controlled Clinical Trial on the Treatment of Upper Urinary Tract Stones With VISOR and fURS","Inclusion Criteria:\n\n* Patients with upper urinary tract stones and a cumulative stone diameter ≤3 cm;\n* Patients scheduled to undergo \"flexible ureteroscopic holmium laser lithotripsy\";\n* Age ≥18 years;\n* Patients without psychiatric disorders or language dysfunction, capable of understanding the study and providing informed consent.\n\nExclusion Criteria:\n\n* Patients requiring bilateral lithotripsy in a single-stage ureteroscopic procedure;\n* Ipsilateral hydronephrosis with \\>4 cm renal pelvic separation;\n* Patients with a history of open or laparoscopic renal and\u002For ureteral surgery;\n* Fever (body temperature ≥38°C) due to urinary tract infection or other causes within one week prior to surgery;\n* Pregnant women;\n* Patients with severe systemic diseases, cardiac diseases, pulmonary insufficiency, or vital organ failure unable to tolerate anesthesia or surgery (ASA score ≥3);\n* Patients with anatomical abnormalities such as polycystic kidney, horseshoe kidney, or ectopic kidney;\n* Patients with coagulation disorders (e.g., INR \\>2.0 or platelet count \\\u003C80×10⁹\u002FL);\n* Patients currently participating in other device or drug clinical trials;\n* Patients deemed ineligible for the trial by the investigator.","ALL","18 Years",{"count":45,"type":46},100,"ESTIMATED","INTERVENTIONAL",[49],"NA","This prospective randomized controlled clinical study aims to evaluate the safety and efficacy of a novel Vortex Intelligence Stone Optimized Removal (VISOR,The experimental group) system compared to a single-use ureterorenoscope (the control) for treating upper urinary tract stones.\n\nA total of 100 patients with upper urinary tract stones (cumulative stone diameter ≤3 cm) will be enrolled and randomly assigned in a 1:1 ratio to either the experimental group (n=50) or the control group (n=50). The experimental group will undergo surgery using the innovative system, which integrates irrigation-suction, pressure monitoring-regulation, and lithotripsy-evacuation functions. The control group will be treated with a conventional single-use ureterorenoscope.\n\nThe primary outcome measure is the immediate stone-free rate (SFR), defined as the proportion of patients with residual fragments \\\u003C4 mm on renal non-contrast computed tomography (NCCT) performed within 24 hours postoperatively. Key secondary endpoints include the SFR at 3 months, operative and lithotripsy times, total laser energy used, intraoperative ureteral injury (Traxer grading), postoperative pain scores, incidence of fever (\\>38.0°C), and overall complication rates (Clavien-Dindo classification).\n\nPatient follow-up assessments will be conducted at 24 hours, 21±7 days, and 90±14 days post-surgery to monitor stone clearance, complications, and recovery. This study seeks to determine if the novel system offers superior stone clearance while maintaining a safe renal pelvic pressure profile, potentially improving outcomes for patients with larger renal stones treated ureteroscopically.",[52,53,54,55],"Urolithiasis, Calcium Oxalate","Ureteroscopy","Therapeutic Irrigation","Intraoperative Complications",[57,58,59,60,61,9,62],"Ureterorenoscopy","Upper urinary tract calculi","Intrarenal pressure","Stone-free rate (SFR)","Lithotripsy","Vortex intelligence Stone Optimized Removal(VISOR）","NOT_YET_RECRUITING","2025-09-12",{"date":66,"type":67},"2025-09-18","ACTUAL",{"date":69,"type":46},"2025-09-20",{"date":71,"type":46},"2026-12-31",{"name":5,"class":6}]