Study Comparing a New Prostate Biopsy Needle and Retrieval Device to Standard Biopsy Methods for Men with Prostate Disease

What this Trial Is About

Researchers are evaluating the performance and safety of the SUREcore biopsy needle and the coreCARE specimen retrieval device compared to a standard biopsy needle and tissue container in men undergoing prostate biopsy. The study aims to assess whether these new devices improve the quality and completeness of prostate tissue samples, which are often fragmented with current biopsy tools. This post-market study is sponsored by Uro-1 Medical and involves men diagnosed with prostate disease or prostate cancer. Participants will undergo prostate tissue biopsy following a 12-core systematic template. Six samples will be collected using the standard biopsy needle and six with the SUREcore needle. The tissue samples will then be randomly retrieved either by the swiping method or using the coreCARE device. The study compares the amount and quality of tissue collected with each method, and users will rate the ease of use of the biopsy tools during the procedure. During and up to five days after the biopsy procedure, researchers will monitor for any adverse events. Pathologists will evaluate the quality of the tissue cores obtained, and users will provide feedback on the biopsy devices. Primary outcomes measured include procedure success, core tissue length, tissue weight, and tissue sample preparation, all assessed on the day of the procedure. Participants will also be asked to verbally assess their condition five days following the biopsy.

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