[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-urolithiasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-urolithiasis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,76,103,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640160","vacuum-assisted-mini-percutaneous-versus-transurethral-cystolithotripsy-in-pediatric-bladder-stones-100640160",false,"NCT07614880","Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones","Vacuum-Assisted Mini-Percutaneous Cystolithotomy Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Study","VAMPCL-Ped","Inclusion Criteria:\n\n* Children aged 2 to 14 years.\n* Diagnosis of bladder stone or stones measuring 10-30 mm in maximum cumulative diameter, confirmed by ultrasound.\n* Normal upper urinary tract.\n* Fit for general anesthesia.\n* Written informed consent obtained from parents or legal guardians.\n\nExclusion Criteria:\n\n* Known urethral stricture or posterior urethral valves.\n* Active urinary tract infection at the time of surgery.\n* Coagulopathy or uncorrected bleeding disorder.\n* Previous open bladder surgery.\n* Any anatomical or clinical condition that, in the investigator's judgment, precludes safe endoscopic or percutaneous cystolithotripsy.","ALL","2 Years","14 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","This prospective randomized pilot study will compare vacuum-assisted mini-percutaneous cystolithotripsy with standard transurethral cystolithotripsy for the treatment of bladder stones in children. Forty children aged 2 to 14 years with bladder stone(s) measuring 10 -30 mm will be randomly assigned to one of two surgical approaches. The vacuum-assisted mini-percutaneous group will undergo suprapubic percutaneous access using a mini sheath with suction-assisted fragment evacuation, while the transurethral group will undergo standard transurethral cystolithotripsy. The primary outcome will be total operative time. Secondary outcomes will include stone-free rate ,lithotripsy time and fragment clearance time, urethral mucosal injury, postoperative hematuria, fever, urinary tract infection, sepsis, urinary retention, urinary leakage from the suprapubic tract, catheterization time, hospital stay, postoperative pain, analgesic requirement, need for auxiliary procedures or conversion, and recurrence or urethral stricture-related symptoms during follow-up.",[28,29,30],"Pediatric Bladder Stones","Bladder Calculi","Pediatric Urolithiasis",[32,33,34,35],"Pediatric bladder stones","Mini-percutaneous cystolithotripsy","Vacuum-assisted cystolithotripsy","Ho:YAG laser lithotripsy","RECRUITING","2026-05-28",{"date":39,"type":40},"2026-06-01","ACTUAL",{"date":42,"type":40},"2026-03-04",{"date":44,"type":22},"2028-03",{"name":46,"class":47},"Beni-Suef University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100640178","dusting-vs-fragmentation-laser-cystolithotripsy-for-pediatric-bladder-stones-100640178","NCT07623980","Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones","Dusting Versus Fragmentation With Holmium:YAG Laser During Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Trial","DUST-FRAG-PED","Inclusion Criteria:\n\n1. Children aged less than 18 years.\n2. Radiologically confirmed single bladder stone less than 3 cm.\n3. Suitable for transurethral cystolithotripsy.\n4. Fit for general anesthesia.\n5. Written informed consent from parents or legal guardians.\n\nExclusion Criteria:\n\n1. Giant bladder stones more than 3 cm.\n2. Urethral pathology preventing safe transurethral access.\n3. Major lower urinary tract anomaly or neurogenic bladder.\n4. Active untreated urinary tract infection.\n5. Coagulation disorder or contraindication to endoscopic surgery.","18 Years",{"count":59,"type":22},110,[25],"Bladder stones are a clinically relevant pediatric urological condition that may require endoscopic treatment. Transurethral Holmium:YAG laser cystolithotripsy is a minimally invasive option for selected children with bladder stones.\n\nThis prospective randomized trial will compare two Holmium:YAG laser strategies during transurethral cystolithotripsy in children with a single bladder stone less than 3 cm: dusting and fragmentation. Children will be randomized to undergo laser dusting or laser fragmentation during transurethral cystolithotripsy.\n\nThe primary outcome is total operative time. Secondary outcomes include laser time, need for active fragment extraction, endoscopic stone-free status at the end of the procedure, ultrasound-assessed stone-free status during follow-up, intraoperative complications, postoperative urinary symptoms, urinary tract infection, need for postoperative catheterization, and hospital stay.",[29,28,30],[64,65,66,67,68],"Transurethral cystolithotripsy","Dusting","Holmium:YAG laser","Fragmentation","Bladder stone surgery",{"date":70,"type":40},"2026-06-03",{"date":72,"type":40},"2026-05-06",{"date":74,"type":22},"2027-05",{"name":46,"class":47},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":102,"locationsCount":48},"100640931","phase-2-intravesical-aminophylline-to-facilitate-ureteroscopic-access-in-children-with-distal-ureteral-stones-100640931","NCT07617896","Intravesical Aminophylline to Facilitate Ureteroscopic Access in Children With Distal Ureteral Stones.","Intravesical Aminophylline to Facilitate Semi-Rigid Ureteroscopic Access in Children With Lower Ureteral Stones: A Prospective Randomized Double-Blind Placebo-Controlled Trial","Inclusion Criteria:\n\n* Children older than 2 years and younger than 18 years.\n* Single unilateral lower\u002Fdistal ureteral stone confirmed by low-dose non-contrast computed tomography according to local policy.\n* Stone size 5 to 15 mm.\n* Candidate for definitive treatment by semi-rigid ureteroscopy.\n* Sterile urine culture before surgery, or previously positive urine culture that has been properly treated before intervention.\n* Intraoperative failed initial gentle negotiation of the ureteric orifice\u002Fintramural ureter according to the study definition.\n* Written informed consent from the parent or legal guardian, with child assent when appropriate.\n\nExclusion Criteria:\n\n* Known hypersensitivity to aminophylline, theophylline, or ethylenediamine.\n* Use of oral or intravenous aminophylline or theophylline within the previous 24 hours.\n* Pre-existing ipsilateral JJ ureteral stent.\n* Stone peeping at the ureteric orifice.\n* Congenital or acquired abnormality that may affect distal ureteric access, such as ureterocele, obstructive megaureter, distal ureteric stricture, previous ureteric reimplantation, or previous ipsilateral ureteral reconstruction.\n* Known bladder dysfunction or conditions likely to affect normal bladder capacity.\n* Multiple ipsilateral ureteral stones or associated renal stones requiring flexible ureteroscopy or a ureteral access sheath strategy.\n* Febrile urinary tract infection, pyonephrosis, sepsis, or any case requiring urgent decompression instead of definitive ureteroscopy.\n* Cardiac disease, arrhythmia, uncontrolled hypertension, hyperthyroidism, epilepsy or seizure disorder, or significant hepatic impairment.\n* Inability to complete follow-up.",{"count":84,"type":22},60,[86],"PHASE2","This study will evaluate whether intravesical aminophylline can facilitate semi-rigid ureteroscopic access in children with distal ureteral stones when the first gentle attempt to enter the ureter is unsuccessful.\n\nChildren scheduled for semi-rigid ureteroscopy for distal ureteral stones will first undergo the standard gentle attempt to pass the ureteroscope through the ureteric orifice and intramural ureter. If access is achieved, the child will continue standard treatment and will not be randomized. If access is not achieved, the child will be randomized during the operation to receive either intravesical aminophylline or intravesical normal saline placebo.\n\nThe study solution will be instilled into the bladder for approximately 5 minutes, then drained, and a second gentle ureteroscopic access attempt will be made. The main outcome is successful same-session passage of the intended semi-rigid ureteroscope without balloon dilation. The study will also assess the need for JJ stenting and deferred ureteroscopy, same-session stone treatment, operative outcomes, complications, and early aminophylline-related safety.",[30,89,90],"Distal Ureteral Stone","Ureteral Calculi",[92,93,94,95,96],"Intravesical Aminophylline","Semi-Rigid Ureteroscopy","Pediatric Ureteroscopy","Ureteroscopic Access","Distal Ureteral Stones","2026-05-25",{"date":39,"type":40},{"date":100,"type":40},"2026-05-09",{"date":74,"type":22},{"name":46,"class":47},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":57,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":48},"100631849","shear-wave-elastography-for-predicting-extracorporeal-shock-wave-lithotripsy-outcomes-in-pediatric-renal-stones-100631849","NCT07506031","Shear Wave Elastography for Predicting Extracorporeal Shock Wave Lithotripsy Outcomes in Pediatric Renal Stones","Evaluating Shear Wave Elastography as a Predictor of Extracorporeal Shock Wave Lithotripsy Outcomes and Stone Composition in Children \"A Prospective Study\"","SWE-ESWL","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  1. Single Renal stones measured 6- 20 mm in maximal dimension.\n  2. ESWL will be planned as the first line of treatment.\n\nExclusion Criteria:\n\n1. Patients with internal ureteral stent.\n2. ureteral stones.\n3. abnormal renal anatomies (pelvic kidney, horseshoe kidney, and rotational anomaly).\n4. active UTI at time of ESWL.\n5. coagulopathy .\n\nExclusion Criteria:\n\n\\-","1 Year",{"count":113,"type":22},108,"OBSERVATIONAL","This prospective study aims to evaluate the role of shear wave elastography (SWE) as a non-invasive and radiation-free tool for predicting the success of extracorporeal shock wave lithotripsy (ESWL) in pediatric patients with renal stones. Currently, computed tomography (CT)-derived Hounsfield units (HU) are used to estimate stone hardness; however, repeated radiation exposure is a concern in children. SWE may provide an alternative method by assessing stone stiffness using ultrasound.\n\nPediatric patients under 18 years with renal stones (6-20 mm) scheduled for ESWL will be included. SWE measurements will be performed prior to treatment, and patients will be followed for 3 months to assess treatment outcomes. The primary outcome is ESWL success, while secondary outcomes include correlation between SWE and HU, number of ESWL sessions required, prediction of stone composition, and assessment of the relationship between SWE measurements and stone composition.\n\nThis study seeks to determine whether SWE can serve as a reliable predictor of ESWL outcomes, correlate with stone composition, and reduce the need for radiation-based imaging in children.",[30],"2026-03-27",{"date":119,"type":40},"2026-04-01",{"date":121,"type":40},"2025-12-02",{"date":123,"type":22},"2026-06",{"name":46,"class":47},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":19,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":48},"100615932","optical-motion-capture-assisted-ultrasound-for-pediatric-eswl-100615932","NCT07299032","Optical Motion Capture-Assisted Ultrasound for Pediatric ESWL","A Randomized Controlled Study on the Localization Efficiency of Optical Motion Capture-Assisted Ultrasound Pre-localization in Pediatric Extracorporeal Shock Wave Lithotripsy","Inclusion Criteria:\n\n* Pediatric patients aged 0 to 14 years with a confirmed diagnosis of upper urinary tract stones.\n* Diagnosis confirmed by ultrasound or low-dose CT; stone long diameter ≤ 20 mm (for upper ureteral stones, diameter ≤ 15 mm); absence of urinary tract structural malformations.\n* Meeting the indications for ESWL with no absolute contraindications, and scheduled to undergo ESWL treatment.\n* Guardians provide informed consent and voluntarily sign the written informed consent form; willing and able to cooperate with the 4-week postoperative follow-up and related examinations.\n* Preoperative assessment reveals no contraindications to ESWL, such as uncontrolled infection, severe coagulation disorders, or severe impairment of cardiopulmonary, hepatic, or renal function.\n\nExclusion Criteria:\n\n* Presence of absolute contraindications for ESWL: Uncontrolled severe urinary tract infection or sepsis; severe uncorrected coagulopathy or current use of anticoagulant\u002Fantiplatelet medications; severe renal impairment (significantly decreased GFR); active severe cardiopulmonary disease rendering the patient unable to tolerate anesthesia or shock wave therapy; or absence of an anatomically safe shock wave path (e.g., due to severe skeletal deformities).\n* Stones suspected to be extremely hard or complex: Refractory stones indicated by excessively high CT Hounsfield Units (HU) or ultrasound Shear Wave Elastography (SWE) values \\> 13.7 kPa; or cystine stones in children \\> 2 years of age (associated with significantly low ESWL success rates).\n* Anatomical or physiological challenges: Severe obesity that compromises ultrasound localization; or patients with a solitary kidney or poor contralateral renal function accompanied by a large stone burden.\n* Prior intervention: History of prior ESWL or other lithotripsy procedures at the target site, which may confound the evaluation of therapeutic efficacy.\n* Underlying systemic conditions: Comorbid severe metabolic diseases or hereditary stone diseases (e.g., cystinuria) requiring priority comprehensive management.\n* Compliance issues: Guardians unable to cooperate with the complete follow-up process, or patients with a high anticipated risk of being lost to follow-up.",{"count":133,"type":22},80,[25],"The incidence of pediatric urinary system stones has shown an upward trend in recent years, and Extracorporeal Shock Wave Lithotripsy (ESWL) has become one of the most important minimally invasive treatments for pediatric upper urinary tract stones. Currently, the widely used clinical ultrasound mechanical coupling localization mode suffers from issues such as limited scanning degrees of freedom and difficulty in intuitively grasping the spatial relationship between the stone and the focal point. These issues lead to prolonged stone pre-localization times, significant reliance on operator experience, and a steep learning curve for young and primary care physicians, thereby restricting the standardization and widespread promotion of pediatric ESWL.\n\nBuilding upon existing ESWL equipment, this project independently constructs an \"Optical Motion Capture-Assisted Ultrasound Pre-localization System.\" By utilizing multi-camera infrared motion capture to acquire the 3D pose of the ultrasound probe and the shock wave source in real-time and establishing a unified spatial coordinate system, the system achieves automatic conversion and visual display of the stone's position from the ultrasound image to the shock wave focal point coordinates. This guides the operator to quickly complete focal point pre-localization after freely scanning for the stone. Results from preliminary phantom studies and initial clinical pilot experiments indicate that, while maintaining the routine ESWL workflow, this system can significantly shorten the first effective pre-localization time for pediatric stones from approximately 15 minutes to around 5 minutes, without a significant decrease in the stone clearance rate. This suggests the technology possesses good engineering feasibility and clinical application prospects.\n\nThis study proposes to conduct a single-center, prospective, single-blind randomized controlled clinical trial. Pediatric patients with upper urinary tract stones eligible for ESWL will be randomly assigned 1:1 to an experimental group and a control group. The experimental group will use the Optical Motion Capture-Assisted Ultrasound Pre-localization System for stone pre-localization, while the control group will use the routine ultrasound mechanical coupling localization method.\n\nThe \\*\\*primary outcome measure\\*\\* is the time to first effective stone pre-localization. \\*\\*Secondary outcomes\\*\\* include the stone clearance rate evaluated by imaging at 4 and 12 weeks post-operation, the total number of shock waves released and total energy, total procedure time, intraoperative and postoperative complication rates, sedation\u002Fanesthesia dosage, and family satisfaction. Additionally, the study will systematically evaluate the system's impact on physician learning curves and work intensity by analyzing the localization success rate of operators with different seniority levels, learning curves (the trend of localization time versus the number of cases), and subjective workload scores.\n\nThe core scientific question this project aims to answer is: Under the premise of not compromising the therapeutic efficacy and safety of pediatric ESWL, can optical motion capture-assisted ultrasound pre-localization significantly improve stone localization efficiency, reduce operator workload, and shorten the learning curve for young physicians, thereby enhancing the standardization and accessibility of pediatric ESWL? The expected results will provide an evidence-based foundation for optimizing pediatric ESWL localization modes and formulating relevant technical standards and training programs. Furthermore, it will lay the clinical validation groundwork for future intelligent lithotripsy systems integrating functions such as intelligent identification and robotic arm automatic tracking.",[30,137,138,139,140,141],"Extracorporeal Shock Wave Lithotripsy","Optical Motion Capture","Ultrasound Localization","Randomized Controlled Trial","Localization Efficiency","NOT_YET_RECRUITING","2026-01-05",{"date":145,"type":40},"2026-01-06",{"date":147,"type":22},"2026-01-01",{"date":149,"type":22},"2028-01-01",{"name":151,"class":47},"The Children's Hospital of Zhejiang University School of Medicine"]