Comparing a new prostate biopsy system to standard biopsy methods
Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Uro-1 Medical Industry-sponsored |
| Locations | 1 site (Cartersville, Georgia) |
| Trial ID | NCT05470127 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adult males who are scheduled for a prostate biopsy and can provide informed consent.
Not a fit: Patients who are unwilling to provide consent or are not scheduled for a prostate biopsy will not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown varying success in improving biopsy techniques, indicating potential for advancement in this area.
Eligibility criteria
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 this trial is running
Cartersville, Georgia
- Georgia Urology — Cartersville, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Thomas Lawson, PhD
- Email: drthomlawson@gmail.com
- Phone: 5102061794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.