Assessment of VMCore Biopsy Versus Standard of Care Biopsy

A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: VMCore Biopsy System; Device: Standard of Care Biopsy Needle

Detailed Description

This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• 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, 30120
      • Recruiting
      • Georgia Urology
      • Contact: Jeffrey Proctor, MD; Phone Number: 770-607-1893

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VMCore Biopsy System; The VMCore biopsy needle will used to collect up to 10 tissue samples.	Device: VMCore Biopsy System; Prostate Examine
Active Comparator: Standard of Care Biopsy Needle; The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples.	Device: Standard of Care Biopsy Needle; Prostate Examine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success	Percentage of tissue samples suitable for pathological review	1 Day of the procedure
Adverse Events	Incidence and Severity of Adverse events associated with use of the biopsy needles	1 Day of the procedure
Patient Pain During use of the biopsy needles	Pain measured with Likert Scale of 1 to 5	1 Day of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Tissue volume for each sample taken	Length and diameter of tissue samples for cubic centimeters of volume	1 Day of the procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: VMCore Assessment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No patient data will be shared among researchers. Tissue data may be shared

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