[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Storz Medical AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100613909","pmcf-investigation-of-modulith-slx-f2-with-storm-track-in-patients-with-kidney-stones-100613909",false,"NCT07272720","PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones","Post-Market Clinical Follow-Up Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones - A Confirmatory Parallel-Group, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Single kidney stone (6 - 15 mm) in the target kidney\n3. Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU\n\nExclusion Criteria:\n\n1. BMI \\> 34.9\n2. Target stone that cannot be localised\n3. Presence of one or more additional stones \\> 4 mm in the target kidney\n4. Presence of one or more additional stones ≤ 4 mm located in the same calyx (upper, mid, or lower pole) or in the renal pelvis as the target stone\n5. Stones with a density value of \\> 1,200 HU\n6. Skin to stone distance (SSD) \\> 160 mm\n7. The presence of obstructions, malformations or other factors preventing targeting or passing of the stone, including but not limited to the following:\n\n   1. Skeletal malformations and obesity, preventing targeting of the stone\n   2. Malignant tumour in the shockwave path\n   3. Arterial aneurysm or calcium deposits, or thrombosis in shockwave path\n   4. Brain, spinal column or air-filled tissue, especially the lungs, in the shockwave path\n   5. Obstruction distal to the stone (as this would hinder the passage of fragments through collecting system or ureter)\n8. Any disease\u002Fmedical condition, prior or concomitant medication\u002Ftreatment\u002Fintervention, or implant that may affect this clinical investigation, and\u002For is contraindicated for the IMD, including but not limited to the following:\n\n   1. Severe nephrocalcinosis\n   2. Uncontrolled urinary tract infection\n   3. Coagulation disorders and bleeding diathesis, not compensated according to urological and hemostaseological guidelines\n   4. Anticoagulation or platelet inhibition therapy, not bridged according to urological and hemostaseological guidelines\n   5. Uncontrolled hypertension\n   6. Blood pressure \\> 180\u002F100\n   7. Active cardiac implants that are not authorized for use with ESWL\n   8. Pancreatitis\n   9. Ehlers-Danlos syndrome\n   10. Administration of contrast agents containing gases for ultrasound diagnostics less than 24 hours before treatment.\n9. Pregnancy","ALL","18 Years",{"count":19,"type":20},126,"ESTIMATED","INTERVENTIONAL",[23],"NA","Extracorporeal shockwave lithotripsy (ESWL) is a non-invasive standard treatment for kidney stones.\n\nThis study will be conducted to evaluate the effectiveness of ESWL using MODULITH® SLX-F2 with stone tracking, compared to MODULITH® SLX-F2 without stone tracking, in adult patients with kidney stones, as measured by stone-free status.",[26,27],"Kidney Stones","Urolithiasis",[29,27,30,31],"Kidney stones","Extracorporeal shockwave lithotripsy","ESWL","RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2025-12-11",{"date":40,"type":20},"2028-10",{"name":42,"class":43},"Storz Medical AG","INDUSTRY",""]