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Recruiting NCT05470127
Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
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Trial Parameters
Condition Prostate Disease
Sponsor Uro-1 Medical
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex MALE
Min Age 18 Years
Max Age 90 Years
Start Date 2022-08-01
Completion 2025-10
All Conditions
Interventions
Prostate biopsy needle
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adult male scheduled for prostate biopsy * Able to provide informed consent * Able and willing to provide verbal assessment of his condition 5 days post-procedure Exclusion Criteria: * Unwilling to provide consent
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