Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
Uro-1 Medical · NCT05470127
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–90 · Men only
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 200
- US sites recruiting
- 1
- Study start
- August 1, 2022
- Record last updated
- May 7, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Prostate biopsy needle
Conditions: Prostate Disease; Prostate CA
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Georgia Urology
Cartersville, GA 30115
Site contact: Jeffrey Proctor, MD · 7706071893 · jproctor@gaurology.com
Study contacts (from the official record)
- Thomas Lawson, PhD · 5102061794 · drthomlawson@gmail.com
- Jack Snoke · 3365750434 · pjsnoke@uro1medical.com