[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"therapeutic-irrigation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:therapeutic-irrigation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"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","VISOR","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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Urolithiasis, Calcium Oxalate","Ureteroscopy","Therapeutic Irrigation","Intraoperative Complications",[32,33,34,35,36,15,37],"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":41,"type":42},"2025-09-18","ACTUAL",{"date":44,"type":21},"2025-09-20",{"date":46,"type":21},"2026-12-31",{"name":48,"class":49},"Ningbo No. 1 Hospital","OTHER"]