Assessment of VMCore Biopsy Versus Standard of Care Biopsy

Status unconfirmed · Not applicable

Conditions studied: Prostate Cancer

In brief

Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.

Key facts

Study ID

NCT04982536

Run by

Uro-1 Medical

People needed

40

Starts

2020-07-19

Expected to finish

2022-08-01

Last updated by the study team

2021-07-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male
• Scheduled for a prostate biopsy
• Able and willing to provide verbal assessment of his condition 5 days post-procedure

You may not qualify if…

• Unable or unwilling to provide consent

Where it is running

• Georgia Urology — Cartersville, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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