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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-90
SponsorUro-1 Medical

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Unwilling to provide consent

Trial design

Treatments tested in this trial

  • Prostate biopsy needle

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators