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

NCT ID: NCT05470127

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Disease Prostate CA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The two biopsy needle sets will be used in the same patient during the procedure.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SUREcore biopsy needle

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

Group Type EXPERIMENTAL

Prostate biopsy needle

Intervention Type DEVICE

Prostate tissue biopsy with a biopsy needle

Standard of Care biopsy needle

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

Group Type ACTIVE_COMPARATOR

Prostate biopsy needle

Intervention Type DEVICE

Prostate tissue biopsy with a biopsy needle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prostate biopsy needle

Prostate tissue biopsy with a biopsy needle

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uro-1 Medical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Lawson, PhD

Role: STUDY_DIRECTOR

Lawson & Associates

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Georgia Urology

Cartersville, Georgia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas Lawson, PhD

Role: CONTACT

5102061794

Jack Snoke

Role: CONTACT

3365750434

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jeffrey Proctor, MD

Role: primary

7706071893

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SUREcore v. SOC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MRI Guided Prostate Biopsy
NCT06302595 RECRUITING NA
Prostate Core Needle Biopsy
NCT02756975 COMPLETED NA
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
NCT05413850 RECRUITING PHASE1/PHASE2