[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628555":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":52,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Ureteral Access Sheath (UAS)","EXPERIMENTAL","Participants receive the standard ureteral access sheath during ureterorenoscopy and laser lithotripsy.",[13],"Device: Standard ureteral access sheath",{"label":15,"type":10,"description":16,"interventionNames":17},"FANS Ureteral Access Sheath (Elephant-II)","Participants receive the Flexible and Navigable Suction (FANS) ureteral access sheath during ureterorenoscopy and laser lithotripsy.",[18],"Device: Flexible and Navigable Suction (FANS) Ureteral Access Sheath",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Standard ureteral access sheath","Participants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Flexible and Navigable Suction (FANS) Ureteral Access Sheath","The Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II), which enables active suction during flexible ureterorenoscopy and laser lithotripsy.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Luca LV Villa","CONTACT","0226439742","villa.luca@hsr.it",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Concetta Cangemi","0226435662","cangemi.concetta@hsr.it",[41],{"facility":42,"status":25,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"IRCCS Ospedale San Raffaele","Milan","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],12.59836,42.78235,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Luca Villa","Medical Doctor","100628555","fans-vs-standard-ureteral-access-sheath-in-furs-100628555",false,"NCT07463157","FANS vs Standard Ureteral Access Sheath in fURS","Comparative Study on the Efficacy of the Ureteral Access Sheath With Integrated Suction FANS Versus the Standard Sheath in Patients With Renal Calculi Undergoing Ureterorenoscopy and Laser Lithotripsy: a Prospective, Randomized, Interventional, Single-center Study","CLEAR-URS","Inclusion Criteria:\n\n1. Participant is willing and able to provide written informed consent before any study-specific procedures are performed.\n2. Male or female, aged 18 years or older.\n3. Diagnosed with renal calculi ≥5 mm in diameter, confirmed by imaging, and eligible for fURS with laser lithotripsy according to European Association of Urology (EAU) guidelines.\n4. In stable general health and fit for elective endoscopic surgery under general anesthesia.\n5. Willing and able to comply with all study-related procedures, including follow-up imaging and clinical assessments.\n\n   \\-\n\nExclusion Criteria:\n\n1. Solitary kidney (monorenal patients).\n2. Untreated positive urine culture or ongoing urinary tract infection not resolved with appropriate antibiotic therapy prior to surgery.\n3. Known anatomical abnormalities of the urinary tract that may interfere with ureteroscopic access or device placement (e.g., ureteral stricture, congenital malformations).\n4. Pregnancy or breastfeeding at the time of enrollment or planning pregnancy during the study period. In all female patients, a Gravindex test is performed on the day of admission; contraceptive measures are not required\n5. Concomitant ureteral stone\n6. Ureteral stenosis\n7. Known allergy or hypersensitivity to materials used in the investigational or control ureteral access sheath.\n8. Any severe comorbid condition (e.g., uncontrolled cardiovascular disease, severe coagulopathy, active malignancy) that in the opinion of the investigator would interfere with study participation or increase procedural risk.\n9. Any psychological, cognitive, or social condition that may limit the ability to provide informed consent or comply with follow-up procedures.","ALL","18 Years",{"count":67,"type":68},134,"ESTIMATED","INTERVENTIONAL",[71],"NA","This is a prospective, interventional single blinded, randomized, single-center study designed to compare the efficacy of a ureteral access sheath with integrated suction (FANS) versus a standard ureteral access sheath (UAS) in patients undergoing ureterorenoscopy and laser lithotripsy for renal stones. The hypothesis is that the use of the FANS device improves stone-free rates and reduces postoperative infectious complications compared to the standard sheath.",[74],"Renal Calculi",[76,77,78,79,80,81],"Renal calculi","Kidney stones","Ureterorenoscopy","Laser lithotripsy","Ureteral access sheath","FANS device","NOT_YET_RECRUITING","2026-03-10",{"date":85,"type":86},"2026-03-12","ACTUAL",{"date":88,"type":68},"2026-03-15",{"date":90,"type":68},"2029-01",{"name":5,"class":6},1]