Assessment of VMCore Biopsy Versus Standard of Care Biopsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: VMCore Biopsy System
* Device: Standard of Care Biopsy Needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will have biopsy performed with both the study needle and a standard of care needle
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VMCore Biopsy System<br>The VMCore biopsy needle will used to collect up to 10 tissue samples. | Device: VMCore Biopsy System<br>* Prostate Examine<br>|
| Active Comparator: Standard of Care Biopsy Needle<br>The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples. | Device: Standard of Care Biopsy Needle<br>* Prostate Examine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | Percentage of tissue samples suitable for pathological review | 1 Day of the procedure | 
| Adverse Events | Incidence and Severity of Adverse events associated with use of the biopsy needles | 1 Day of the procedure | 
| Patient Pain During use of the biopsy needles | Pain measured with Likert Scale of 1 to 5 | 1 Day of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Tissue volume for each sample taken | Length and diameter of tissue samples for cubic centimeters of volume | 1 Day of the procedure |