[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Uro-1 Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100475376","evaluation-of-the-performance-of-a-novel-prostate-biopsy-system-compared-with-standard-of-care-biopsy-needle-on-quantitative-and-qualitative-tissue-parameters-100475376",false,"NCT05470127","Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters","Inclusion Criteria:\n\n* Adult male scheduled for prostate biopsy\n* Able to provide informed consent\n* Able and willing to provide verbal assessment of his condition 5 days post-procedure\n\nExclusion Criteria:\n\n* Unwilling to provide consent","MALE","18 Years","90 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"NA","Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.",[26,27],"Prostate Disease","Prostate CA",[27,29],"Needle biopsy","RECRUITING","2025-05-02",{"date":33,"type":34},"2025-05-07","ACTUAL",{"date":36,"type":34},"2022-08-01",{"date":38,"type":20},"2025-12",{"name":40,"class":41},"Uro-1 Medical","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100579897","comparing-standard-of-care-biopsy-system-to-a-novel-biopsy-needle-system-by-computational-pathologic-analysis-100579897","NCT06830265","Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis","Comparing a Standard of Care Prostate Biopsy System with a Novel System Using Standard As Well As Computational Pathology Analyses to Measure Clinical and Morphometric Parameters.","Inclusion Criteria:\n\n* Adult males with PSA density greater than or equal to 0.15\n* Lesions are visible under MRI\n* PIRADS score is greater than or equal to 3\n* Able to and willing to provide consent\n\nExclusion Criteria:\n\n* Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer\n* History of dementia, cognitive impairment, or deep vein thrombosis (DVT)\n* Is a prisoner currently or has a history of incarceration\n* Unable to understand English\n* Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4\n* Has concurrent malignancies\n* Is positive for HIV, HBV, and\u002For HCV infection\n* Has low-performance status",{"count":51,"type":20},20,[23],"Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quantity of tissue retrieved by both systems. Further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and Gleason scores in terms of tissue area, tissue length, and tissue tortuosity.",[55],"Prostate Cancer Screening","NOT_YET_RECRUITING","2025-02-11",{"date":59,"type":34},"2025-02-17",{"date":61,"type":20},"2025-02-15",{"date":63,"type":20},"2026-01-10",{"name":40,"class":41},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100558426","evaluation-of-surecore-plus-biopsy-system-100558426","NCT06550960","Evaluation of SureCore Plus Biopsy System","Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate Using Standard of Care and Artificial Intelligence (AI) Analysis","Inclusion Criteria:\n\n* Patient has BPH requiring a prostate biopsy\n* Able and willing to provide consent\n\nExclusion Criteria:\n\n* Active infection\n* Subject participating in an other device study of the prostate","80 Years",{"count":74,"type":20},30,[23],"This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.",[78],"BPH","2024-08-08",{"date":81,"type":34},"2024-08-13",{"date":83,"type":20},"2024-08-05",{"date":85,"type":20},"2025-02-01",{"name":40,"class":41},""]