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

Recruiting now · Not applicable

Conditions studied: Prostate Disease, Prostate CA

In brief

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.

Key facts

Study ID

NCT05470127

Run by

Uro-1 Medical

People needed

200

Starts

2022-08-01

Expected to finish

2025-12-01

Last updated by the study team

2025-05-07

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Unwilling to provide consent

Where it is running

• Georgia Urology — Cartersville, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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