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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

Recruiting

Who can join

Ages 18 to 90 · Men

Full 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

About the study

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.

What is being tested

Sponsor: Uro-1 Medical · Participants: 200 · Started: Aug 1, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05470127

Locations in the U.S.

GeorgiaGeorgia Urology, Cartersville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.