Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of
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
| Condition(s) | Prostate Disease, Prostate CA |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Lead sponsor | Uro-1 Medical |
| Locations | Cartersville, Georgia, United States |
| Start date | 2022-08-01 |
| NCT ID | NCT05470127 |
| Official listing | https://clinicaltrials.gov/study/NCT05470127 |