Assessment of VMCore Biopsy Versus Standard of Care Biopsy

Uro-1 Medical

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: Standard of Care Biopsy Needle; Device: VMCore Biopsy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04982536

VMCore Assessment

Details and patient eligibility

About

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.

Full description

This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Unable or unwilling to provide consent

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

VMCore Biopsy System

Experimental group

Description:

The VMCore biopsy needle will used to collect up to 10 tissue samples.

Treatment:

Device: VMCore Biopsy System

Standard of Care Biopsy Needle

Active Comparator group

Description:

The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples.

Treatment:

Device: Standard of Care Biopsy Needle