[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558426":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":25,"responsibleParty":36,"collaborators":25,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":25,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":25,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":25,"overallStatus":57,"whyStopped":25,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":25},{"fullName":5,"class":6},"Uro-1 Medical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SureCore Plus biopsy needle","EXPERIMENTAL","Prostate biopsy of subject with BPH with a SureCore biopsy needle",[13],"Device: Evaluation of two biopsy systems",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care biopsy needle","ACTIVE_COMPARATOR","Prostate biopsy of subject with BPH with a standard of care (SOC) biopsy needle",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Evaluation of two biopsy systems","Each subject will have prostate biopsy taken in 6 locations in one lobe of the prostate and then biopsy in 6 locations in the other lobe of the prostate",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Jeffrey Proctor, MD","Georgia Urology","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","770 607 1893","jproctor@georgiaurology.com",{"type":37,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100558426","evaluation-of-surecore-plus-biopsy-system-100558426",false,"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","MALE","18 Years","80 Years",{"count":49,"type":50},30,"ESTIMATED","INTERVENTIONAL",[53],"NA","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.",[56],"BPH","NOT_YET_RECRUITING","2024-08-08",{"date":60,"type":61},"2024-08-13","ACTUAL",{"date":63,"type":50},"2024-08-05",{"date":65,"type":50},"2025-02-01",{"name":5,"class":6}]