Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
MALE
NCT05470127

Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

Led by Uro-1 Medical · Updated on 2025-05-07

200

Participants Needed

1

Research Sites

174 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

Who Can Participate

Age: 18Years - 90Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Unwilling to provide consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Georgia Urology

Cartersville, Georgia, United States, 30115

Actively Recruiting

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Research Team

T

Thomas Lawson, PhD

CONTACT

J

Jack Snoke

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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