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

Not Applicable

Recruiting

• Conditions: Prostate Disease; Prostate CA

• Registration Number: NCT05470127
• Lead Sponsor: Uro-1 Medical

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-22
• Study Start: 2022-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Core length of tissue in the sample	1 Day of the procedure	Quantity of Tissue Samples Collected
weight of tissue in the sample	1 Day of the procedure	Quantity of Tissue Samples Collected
Tissue Sample Preparation	1 Day of the procedure	Time required to prepare the tissue samples for pathological review
Procedure Success	1 Day of the procedure	Percentage of tissue samples collected that are suitable for pathological review

Secondary Outcome Measures

Name	Time	Method
Ease of use of the biopsy needle	1 Day of the procedure	Utility of the biopsy needle measured with a Likert scale of 1 to 5

Trial Locations

Locations (1)

Georgia Urology; 🇺🇸 Cartersville, Georgia, United States