Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
Recruiting
N/A
Interventional Study
Prostate Disease
Prostate CA
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 90
- Sex
- Male
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 200 (estimated)
- Sponsor
- Uro-1 Medical · Industry
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About This Trial
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…
Trial Locations
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Eligibility 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
Contacts