RecruitingNot ApplicableNCT05470127
Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
Sponsor
Uro-1 Medical
Enrollment
200 participants
Start Date
Aug 1, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: MALEMin Age: 18 YearsMax Age: 90 Years
Inclusion Criteria3
- 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 Criteria1
- Unwilling to provide consent
Interventions
DEVICEProstate biopsy needle
Prostate tissue biopsy with a biopsy needle
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05470127
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