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

NCT05470127 | Recruiting FDA Device

• 1 other identifier: SUREcore v. SOC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Disease; Prostate CA

Keywords

Prostate CA; Needle biopsy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Ease of use of the biopsy needle

  1 Day of the procedure

Study Arms (2)

SUREcore biopsy needle

EXPERIMENTAL

The SUREcore needle will be used to collect up to 10 tissue samples

Device: Prostate biopsy needle

Standard of Care biopsy needle

ACTIVE COMPARATOR

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

Device: Prostate biopsy needle

Interventions

Prostate biopsy needle DEVICE

Prostate tissue biopsy with a biopsy needle

SUREcore biopsy needle; Standard of Care biopsy needle

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Prostate tissue is to be collected, which is only present in males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwilling to provide consent

Sponsors & Collaborators

• Uro-1 Medical: lead

Study Sites (1)

Georgia Urology

Cartersville, Georgia, 30115, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Thomas Lawson, PhD

  Lawson & Associates

  STUDY DIRECTOR

Central Study Contacts

Thomas Lawson, PhD

CONTACT

5102061794; drthomlawson@gmail.com

Jack Snoke

CONTACT

3365750434; pjsnoke@uro1medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The two biopsy needle sets will be used in the same patient during the procedure.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 22, 2022
• Study Start: August 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

US (1)