Recruiting

VMCore vs. Standard

Sponsor:

Uro-1 Medical

Code:

NCT04982536

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VMCore Biopsy System

Standard of Care Biopsy Needle

Study Details

Brief summary:

Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.

Conditions

Prostate Cancer

Study ID

NCT04982536

Start date

Jul 19, 2020

Status verified date

Jul, 2021

Completion date

Aug 1, 2022

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male
  • Scheduled for a prostate biopsy
  • Able and willing to provide verbal assessment of his condition 5 days post-procedure

Exclusion Criteria:

  • Unable or unwilling to provide consent

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: VMCore Biopsy System

The VMCore biopsy needle will 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

VMCore Biopsy System

Prostate Examine

Standard of Care Biopsy Needle

Prostate Examine

Primary outcome measure

  • Procedure Success [ Time Frame: 1 Day of the procedure ]
  • Adverse Events [ Time Frame: 1 Day of the procedure ]
  • Patient Pain During use of the biopsy needles [ 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, 30120

Contacts

Jeffrey Proctor, MD

770-607-1893

More Information

Sponsor

Uro-1 Medical

Last update posted

Jul 29, 2021

Last verified

Jul, 2021

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 2021-07-29.