[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579897":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":24,"responsibleParty":39,"collaborators":41,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":24,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":24,"enrollmentInfo":56,"targetDuration":24,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":24,"overallStatus":65,"whyStopped":24,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":24},{"fullName":5,"class":6},"Uro-1 Medical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test group","ACTIVE_COMPARATOR","The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe.",[13],"Device: Novel needle biopsy catheter (test)",{"label":15,"type":10,"description":16,"interventionNames":17},"Single Arm","The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Novel needle biopsy catheter (test)","Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Ted Belleza","STUDY_DIRECTOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Ted Belleaza","CONTACT","831-295-7133","tbelleza@uro1medical.com",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Thomas Lawson, PHD","510-206-1794","drthomlawson@gmail.com",{"type":40,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[42,45],{"name":43,"class":44},"Duke University","OTHER",{"name":46,"class":44},"NYU Langone Health","100579897","comparing-standard-of-care-biopsy-system-to-a-novel-biopsy-needle-system-by-computational-pathologic-analysis-100579897",false,"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","MALE","18 Years",{"count":57,"type":58},20,"ESTIMATED","INTERVENTIONAL",[61],"NA","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.",[64],"Prostate Cancer Screening","NOT_YET_RECRUITING","2025-02-11",{"date":68,"type":69},"2025-02-17","ACTUAL",{"date":71,"type":58},"2025-02-15",{"date":73,"type":58},"2026-01-10",{"name":5,"class":6}]