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 type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | Uro-1 Medical Industry-sponsored |
| Locations | 1 site (Cartersville, Georgia) |
| Status | Recruiting |
| Started | August 1, 2022 |
| Main results expected | October 2025 |
| Study ends | December 2025 |
| Registry record updated | May 7, 2025 |
| Trial ID | NCT05470127 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
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Georgia Urology
Cartersville, Georgia, United States Recruiting
Study contacts
- Study coordinator: Thomas Lawson, PhD
- Email: drthomlawson@gmail.com
- Phone: 5102061794
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.