[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475376":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":62,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Uro-1 Medical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SUREcore biopsy needle","EXPERIMENTAL","The SUREcore needle will be used to collect up to 10 tissue samples",[13],"Device: Prostate biopsy needle",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care biopsy needle","ACTIVE_COMPARATOR","The urologist will use his\u002Fher standard biopsy needle to collect up to 15 tissue samples",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Prostate biopsy needle","Prostate tissue biopsy with a biopsy needle",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Thomas Lawson, PhD","Lawson & Associates","STUDY_DIRECTOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","5102061794","drthomlawson@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Jack Snoke","3365750434","pjsnoke@uro1medical.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Georgia Urology","RECRUITING","Cartersville","Georgia","30115","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-84.80231,34.16533,{"lat":53,"lon":52},[56,60],{"name":57,"role":33,"phone":58,"phoneExt":25,"email":59},"Jeffrey Proctor, MD","7706071893","jproctor@gaurology.com",{"name":57,"role":61,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":74,"type":75},200,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81,82],"Prostate Disease","Prostate CA",[82,84],"Needle biopsy","2025-05-02",{"date":87,"type":88},"2025-05-07","ACTUAL",{"date":90,"type":88},"2022-08-01",{"date":92,"type":75},"2025-12",{"name":5,"class":6},1]