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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Disease; Prostate CA
• Intervention / Treatment: Device: Prostate biopsy needle

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Lawson, PhD; Phone Number: 5102061794; Email: drthomlawson@gmail.com
• Study Contact Backup: Name: Jack Snoke; Phone Number: 3365750434; Email: pjsnoke@uro1medical.com

Study Locations

• United States
  • Georgia
    • Cartersville, Georgia, United States, 30115
      • Recruiting
      • Georgia Urology
      • Contact: Jeffrey Proctor, MD; Phone Number: 7706071893; Email: jproctor@gaurology.com
      • Principal Investigator: Jeffrey Proctor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUREcore biopsy needle; The SUREcore needle will be used to collect up to 10 tissue samples	Device: Prostate biopsy needle; Prostate tissue biopsy with a biopsy needle
Active Comparator: Standard of Care biopsy needle; The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples	Device: Prostate biopsy needle; Prostate tissue biopsy with a biopsy needle

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uro-1 Medical
• Investigators: Study Director: Thomas Lawson, PhD, Lawson & Associates

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Needle biopsy; Prostate CA
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Prostatic Diseases
• Other Study ID Numbers: SUREcore v. SOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Likert scale means for use of either of the biopsy needles will be available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No