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

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new prostate biopsy system to see if it can more accurately detect prostate cancer compared to current standard biopsy methods. **You may be eligible if...** - You have been referred for a prostate biopsy due to elevated PSA levels or abnormal findings on imaging - You are an adult male meeting the specific health criteria for the procedure - You are willing to undergo the study biopsy procedure **You may NOT be eligible if...** - You are on blood thinners (anticoagulants) that cannot be safely paused for the procedure - You have a serious active urinary infection - You have anatomy that makes a prostate biopsy technically unsafe - You have previously had a prostatectomy (surgical removal of the prostate) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEProstate biopsy needle

Prostate tissue biopsy with a biopsy needle


Locations(1)

Georgia Urology

Cartersville, Georgia, United States

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NCT05470127


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