Recruiting

Prostate Biopsy System

Sponsor:

Uro-1 Medical

Code:

NCT05470127

Conditions

Prostate Disease

Prostate CA

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Prostate biopsy needle

Study Details

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

Study ID

NCT05470127

Start date

Aug 1, 2022

Status verified date

May, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: SUREcore biopsy needle

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

active comparator: Standard of Care biopsy needle

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

Interventions

Prostate biopsy needle

Prostate tissue biopsy with a biopsy needle

Primary outcome measure

  • Procedure Success [ Time Frame: 1 Day of the procedure ]
  • Core length of tissue in the sample [ Time Frame: 1 Day of the procedure ]
  • weight of tissue in the sample [ Time Frame: 1 Day of the procedure ]
  • Tissue Sample Preparation [ Time Frame: 1 Day of the procedure ]

Central Contacts and Locations

Central contacts

Thomas Lawson, PhD

5102061794drthomlawson@gmail.com

Jack Snoke

3365750434pjsnoke@uro1medical.com

Locations

Georgia Urology

Recruiting

Cartersville, Georgia, United States, 30115

Contacts

Jeffrey Proctor, MD

7706071893jproctor@gaurology.com

Principal Investigator:

Jeffrey Proctor, MD

More Information

Sponsor

Uro-1 Medical

Last update posted

May 7, 2025

Last verified

May, 2025

Keywords

  • Prostate CA
  • Needle biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uro-1 Medical on 2025-05-07.