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Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

RecruitingNAAges 18 Years - 90 YearsMaleUro-1 Medical
NCT05470127 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Prostate biopsy needle
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Where

1 site
Georgia Urology
Cartersville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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