Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
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.
Description
The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to r…
Eligibility
- Age range
- 18–90 years
- Sex
- Male
- Healthy volunteers
- No
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
Interventions
- DeviceProstate biopsy needle
Prostate tissue biopsy with a biopsy needle
Location
- Georgia UrologyCartersville, Georgia