[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585119":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":71,"collaborators":74,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":42,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":42,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Steerable FANS Arm","EXPERIMENTAL","Participants assigned to this arm will undergo flexible ureteroscopy using the novel steerable flexible and navigable suction ureteral access sheath (FANS). This device incorporates an active deflection mechanism that allows for independent adjustment to optimize navigation into the lower pole calyx. The procedure is performed under general anesthesia with a standardized 7.5 Fr digital flexible ureteroscope, using a 200 µm holmium laser (energy settings ≤30 W) for lithotripsy, and continuous negative-pressure suction for stone fragment aspiration. Adjunct devices (e.g., stone baskets) may be utilized if necessary.",[13],"Device: Steerable FANS",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional FANS Arm","ACTIVE_COMPARATOR","Participants assigned to this arm will receive flexible ureteroscopy using the conventional flexible and navigable suction ureteral access sheath (FANS), which relies on passive deflection provided by the ureteroscope for navigation into the lower pole calyx. The procedure is conducted under general anesthesia with a 7.5 Fr digital flexible ureteroscope, employing a 200 µm holmium laser (energy settings ≤30 W) for lithotripsy and continuous negative-pressure suction for fragment removal. Adjunctive retrieval tools (e.g., stone baskets) may be used as required.",[19],"Device: Conventional FANS",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Steerable FANS","This device is designed for flexible ureteroscopy procedures in patients with lower pole renal stones ≤2 cm. It features an active deflection mechanism that enables independent adjustment to enhance access into the lower pole calyx. The description focuses solely on the device and does not include procedural details already provided in the arm description.",[9],[27],"Steerable Flexible and Navigable Suction Ureteral Access Sheath",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Conventional FANS","This device is intended for use in flexible ureteroscopy for lower pole renal stone management. It relies on passive deflection provided by the flexible ureteroscope for navigation into the lower pole calyx. The description is limited to the device characteristics without duplicating procedural details from the arm description.",[15],[33],"Conventional Flexible and Navigable Suction Ureteral Access Sheath",[35],{"name":36,"affiliation":5,"role":37},"Guohua Zeng, M.D.","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","13622754991",null,"gzgyzgh@vip.sina.com",{"name":45,"role":40,"phone":42,"phoneExt":42,"email":46},"Steffi Yuen, M.D.","Steffiyuen@surgery.cuhk.edu.hk",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of Urology, The First Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510230","China","CN",{"type":57,"coordinates":58},"Point",[59,60],113.25,23.11667,{"lat":60,"lon":59},[63,65,68,69],{"name":36,"role":40,"phone":64,"phoneExt":42,"email":43},"+8613802916676",{"name":66,"role":40,"phone":42,"phoneExt":42,"email":67},"Wei Zhu, M.D.","doczw1989@126.com",{"name":36,"role":37,"phone":42,"phoneExt":42,"email":42},{"name":66,"role":70,"phone":42,"phoneExt":42,"email":42},"SUB_INVESTIGATOR",{"type":37,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Guohua Zeng","Vice president",[75,77,79,81,83,86,88,90,92,95,97,99,101,103,105,107,109,111,113],{"name":76,"class":6},"Third Medical Center of Chinese PLA General Hospital",{"name":78,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":80,"class":6},"Peking University People's Hospital",{"name":82,"class":6},"The Second Affiliated Hospital of Kunming Medical University",{"name":84,"class":85},"The Fifth Affiliated Hospital, Sun Yat-sen University","UNKNOWN",{"name":87,"class":6},"Henan Provincial People's Hospital",{"name":89,"class":6},"Nanfang Hospital, Southern Medical University",{"name":91,"class":6},"Wuhan Hospital of Traditional Chinese Medicine",{"name":93,"class":94},"Dongguan People's Hospital","OTHER_GOV",{"name":96,"class":6},"Changzhou No.2 People's Hospital",{"name":98,"class":6},"Dongguan Tungwah Hospital",{"name":100,"class":6},"Panzhihua Central Hospital",{"name":102,"class":6},"Yan'an Affiliated Hospital of Kunming Medical University",{"name":104,"class":85},"NO.1 People's Hospital of Dali City",{"name":106,"class":6},"Huadu District People's Hospital of Guangzhou",{"name":108,"class":6},"Jiangmen Central Hospital",{"name":110,"class":85},"Shaoyang Central Hospital",{"name":112,"class":85},"Guangzhou Medical University Affiliated Qingyuan Hospital",{"name":114,"class":6},"Dongguan Kanghua Hospital","100585119","steerable-vs-conventional-fans-for-2cm-lower-pole-stone-treatment-sculpt-trial-100585119",false,"NCT06898216","Steerable vs Conventional FANS for \u003C2cm Lower Pole Stone Treatment: SCULPT Trial","Flexible Ureteroscopy With Steerable Versus Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) Utility in Less Than 2cm Lower Pole Stones Treatment: a Multicenter, Randomized Superiority Trial (SCULPT Trial)","Inclusion Criteria:\n\n* Adults aged 18-75 years\n* Diagnosed with a single lower pole renal stone ≤2 cm by CT\n* American Society of Anesthesiology (ASA) score of 1-3\n* Ability to provide written informed consent\n* Willingness and ability to comply with trial procedures and follow-up\n\nExclusion Criteria:\n\n* Patients with urinary tract anatomical abnormalities (e.g., horseshoe kidney, ileal conduit)\n* Untreated urinary tract infection\n* Presence of multiple stones or stones located outside the lower pole\n* Absolute contraindications to flexible ureteroscopy\n* Inability to understand or complete trial documentation","ALL","18 Years","75 Years",{"count":126,"type":127},400,"ESTIMATED","INTERVENTIONAL",[130],"NA","This multicenter, randomized, controlled superiority trial (the SCULPT trial) aims to compare the efficacy and safety of a novel steerable flexible and navigable suction ureteral access sheath (FANS) versus the conventional FANS in the treatment of lower pole renal stones ≤2 cm. Lower pole stones are particularly challenging due to the narrow infundibular-pelvic anatomy that limits the maneuverability of standard FANS. The steerable FANS incorporates an active deflection mechanism that allows for independent control, potentially improving the success rate of accessing the lower pole calyx, performing laser lithotripsy, and aspirating stone fragments without additional adjuncts.\n\nA total of 400 patients from 20 high-volume urological centers in China (approximately 20 patients per center) will be randomized in a 1:1 ratio to receive either steerable FANS or conventional FANS during flexible ureteroscopy. Primary outcome measures include the success rate of FANS navigation into the lower pole calyx as evidenced by direct stone visualization, effective laser lithotripsy, and successful stone aspiration. Secondary outcomes will assess immediate and 1-month stone-free rates, operative time, complication rates, instrument durability, and improvements in quality of life. This study is expected to provide critical evidence to guide clinical decision-making and potentially improve treatment efficiency for challenging lower pole renal stones.",[133],"Kidney Stones",[135,136,137,138,139],"flexible ureteroscopy","flexible and navigable suction ureteral access sheath","FANS","lower pole","renal stones","2025-03-20",{"date":142,"type":143},"2025-03-27","ACTUAL",{"date":145,"type":143},"2025-03-16",{"date":147,"type":127},"2026-03-01",{"name":5,"class":6},1]