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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

Comparing new prostate biopsy system with standard biopsy needle.

Recruiting
18-90 years
Male
Phase N/A

This study looks at a new prostate biopsy tool called the **SUREcore biopsy needle** and a **coreCARE specimen retrieval device**. A biopsy is when doctors take a small piece of tissue to look for disease. The study compares these new tools with the usual ones used in clinics. The goal is to see if the new tools collect better tissue samples, which makes it easier for doctors to check for problems in the prostate. The **prostate** is a gland in men that helps make fluid for semen.

Doctors will take 12 tissue samples from the prostate. Six samples will use the usual needle, and six samples will use the SUREcore needle. The samples will be collected in different ways to see which method works best. Doctors will watch for any problems during and after the procedure. Participants will share how they feel about the tools, and a doctor called a **pathologist** will check the quality of the samples.

  • The study is for adult males having a prostate biopsy.
  • Participants will need to talk about their condition 5 days after the procedure.
  • Participants must be able to provide consent.
Study details
    Prostate Disease
    Prostate CA

NCT05470127

Uro-1 Medical

11 May 2025

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