Clinical trial Recruiting at 1 site Interventional Ages 18 to 90 Men only

Comparing a new prostate biopsy system to standard biopsy methods

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

Run by Uro-1 Medical · NCT05470127 · Data updated 2026-11-12

This study is testing a new prostate biopsy system to see if it collects better tissue samples than the standard biopsy method for men needing a biopsy.

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexMen only
Enrollment200 (estimated)
SponsorUro-1 Medical
Industry-sponsored
Locations1 site (Cartersville, Georgia)
StatusRecruiting
StartedAugust 1, 2022
Main results expectedOctober 2025
Study endsDecember 2025
Registry record updatedMay 7, 2025
Trial IDNCT05470127 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adult males who are scheduled for a prostate biopsy and can provide informed consent.

Probably not a fit

Patients who are unwilling to provide consent or are not scheduled for a prostate biopsy will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the performance of a novel prostate biopsy system, the SUREcore biopsy needle and coreCARE specimen retrieval device, against the standard biopsy needle and typical tissue container used in urology. The study involves obtaining prostate tissue samples from adult males scheduled for biopsy, using a systematic approach to collect samples with both devices. Participants will provide informed consent and will be monitored for adverse events during and after the procedure, while pathologists will assess the quality of the tissue cores obtained.

Why it matters

Potential benefit: If successful, this study could lead to improved tissue quality for prostate cancer diagnosis, enhancing the accuracy of pathological reviews.

How similar studies have gone: While this approach is innovative, similar studies have shown varying success in improving biopsy techniques, indicating potential for advancement in this area.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Georgia Urology
    Cartersville, Georgia, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.