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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
Sponsor: Uro-1 Medical
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.
Key Details
Gender
MALE
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-08-01
Completion Date
2025-12
Last Updated
2025-05-07
Healthy Volunteers
No
Conditions
Interventions
Prostate biopsy needle
Prostate tissue biopsy with a biopsy needle
Locations (1)
Georgia Urology
Cartersville, Georgia, United States