Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate

Study Overview
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Brief Summary
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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.

Detailed Description
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The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.

Official Title
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Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate

Conditions
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Prostate Disease

Intervention / Treatment
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* Device: Prostate biopsy needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unwilling to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The two biopsy needle sets will be used in the same patient during the procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUREcore biopsy needle<br>The SUREcore needle will be used to collect up to 10 tissue samples | Device: Prostate biopsy needle<br>* Prostate tissue biopsy with a biopsy needle<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: Prostate biopsy needle<br>* Prostate tissue biopsy with a biopsy needle<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 collected that are suitable for pathological review | 1 Day of the procedure | 
| Core length of tissue in the sample | Quantity of Tissue Samples Collected | 1 Day of the procedure | 
| weight of tissue in the sample | Quantity of Tissue Samples Collected | 1 Day of the procedure | 
| Tissue Sample Preparation | Time required to prepare the tissue samples for pathological review | 1 Day of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use of the biopsy needle | Utility of the biopsy needle measured with a Likert scale of 1 to 5 | 1 Day of the procedure |