[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598473":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":56,"collaborators":31,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":31,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":31,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":40,"whyStopped":31,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VISOR Treatment","EXPERIMENTAL","All enrolled participants (n=20) will undergo upper urinary tract stone removal using the investigational device VISOR (Vortex Intelligence Stone Optimized Removal). The procedure includes:\n\n1. Integrated irrigation-aspiration and real-time pressure monitoring\u002Fcontrol (safety threshold: \\\u003C30 mmHg).\n2. Holmium laser lithotripsy with simultaneous stone fragment removal.\n3. Postoperative assessment:\n\nUrinary CT scan at 24h to determine immediate stone-free rate (residual stones \\\u003C4 mm).\n\nFollow-up imaging (CT\u002Fultrasound) and complication monitoring at 28±7 days.",[13],"Device: Multifunctional Integrated Flexible Ureteroscope",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Multifunctional Integrated Flexible Ureteroscope","Investigational ureteroscope with three integrated functions:\n\n1. Real-time pressure control: Continuous renal pelvic pressure monitoring with auto-adjustment of irrigation\u002Faspiration flow to maintain pressure \\\u003C30 mmHg (safety threshold)\n2. Simultaneous lithotripsy \\& fragment removal: Holmium laser lithotripsy (200-365 μm fiber) coordinated with suction through working channel\n3. Single-pass stone clearance: Designed to reduce residual fragments requiring secondary procedures\n\nDistinguishing features vs conventional ureteroscopes:\n\n1. Eliminates need for separate suction devices\n2. Prevents intraoperative \"washout failure\" causing obscured vision\n3. Patent-pending pressure sensor",[9],[21],"Xinwell Scope",[23],{"name":24,"affiliation":25,"role":26},"Bohan Wang, MD., Ph.D","2nd Affiliated Hospital, School of Medicine, Zhejiang University, China","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+86-13575799866",null,"wangbohan@zju.edu.cn",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Wenjun Gao, MD., Ph.D","+86-19817482099","gaowenjun@zju.edu.cn",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"2nd Affiliated Hospital, School of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","230000","China","CN",{"type":47,"coordinates":48},"Point",[49,50],120.16142,30.29365,{"lat":50,"lon":49},[53,54],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":55,"phoneExt":31,"email":36},"086-19817482099",{"type":57,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100598473","a-single-center-clinical-study-on-the-efficacy-and-safety-of-visor-100598473",false,"NCT07071948","A Single-Center Clinical Study on the Efficacy and Safety of VISOR","A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)","Inclusion Criteria:\n\n1. Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 1-3 cm\n2. Patients who choose to undergo \"flexible ureteroscopic holmium laser lithotripsy\"\n3. Aged 18-80 years, regardless of gender\n4. Subjects without mental illness or language dysfunction, who can understand the details of this study and sign the informed consent form\n\nExclusion Criteria:\n\n1. Patients with ureteral stricture or a history of ureteral stricture\n2. Patients with a history of open renal and\u002For ureteral surgery or laparoscopic surgery\n3. Fever (body temperature ≥ 38℃) due to urinary tract infection or other reasons within one week before surgery\n4. Pregnant women, lactating women, or women who are in the menstrual period\n5. ASA classification \\> Grade 3: patients with severe systemic diseases, heart diseases, pulmonary insufficiency, and failure of important organ functions, etc., who cannot tolerate anesthesia or surgery\n6. Patients with anatomical malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney\n7. Patients with abnormal coagulation function (e.g., international normalized ratio (INR) \\> 1.5 or platelet count \\\u003C 80 × 10⁹\u002FL)\n8. Patients with failed sheath placement during surgery","ALL","18 Years","80 Years",{"count":69,"type":70},20,"ESTIMATED","INTERVENTIONAL",[73],"NA","Goal of this trial:\n\nTo test a new tool called VISOR in adults (aged 18-80) with 1-3 cm kidney or ureter stones. We want to see:\n\n1. If it's safe and works well\n2. If its built-in features (flushing\u002Fsuction, pressure control, and stone-breaking\u002Fremoval) help clear stones better while keeping surgery safe.\n\nMain questions:\n\n1. Can the VISOR clear stones successfully (with fragments \\\u003C4 mm left) for at least 9 out of every 10 people within 24 hours after surgery?\n2. Will serious problems (like severe infections or ureteral injuries) happen to no more than 1 in 20 people (5%)?\n3. Can the device keep pressure inside the kidney below 30 mmHg (a safe level) during the entire surgery?\n\nWhat participants will do:\n\nHave stone removal surgery using VISOR (breaks and removes stones at the same time).\n\nGet a CT scan within 24 hours after surgery to check if stones are cleared.\n\nReturn 4 weeks (±1 week) after surgery for:\n\nAn imaging test (CT or ultrasound)\n\nA check for any health problems related to the surgery.",[76,77],"Urolithiasis, Calcium Oxalate","Kidney Stone",[79,80,81,82],"urolithiasis","kidney stone","stone free rate","VISOR","2025-09-22",{"date":85,"type":86},"2025-09-26","ACTUAL",{"date":88,"type":86},"2025-08-06",{"date":90,"type":70},"2027-02-28",{"name":5,"class":6},1]