Assessment of VMCore Biopsy Versus Standard of Care Biopsy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982536
• Other study ID #: VMCore Assessment
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2021
• Source: Uro-1 Medical
• Contact: Thomas Lawson, PhD
• Phone: 5102061794
• Email: drthomlawson[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• VMCore Biopsy System
Prostate Examine
• Standard of Care Biopsy Needle
Prostate Examine

Locations

Country	Name	City	State
United States	Georgia Urology	Cartersville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Uro-1 Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Success	Percentage of tissue samples suitable for pathological review	1 Day of the procedure
Primary	Adverse Events	Incidence and Severity of Adverse events associated with use of the biopsy needles	1 Day of the procedure
Primary	Patient Pain During use of the biopsy needles	Pain measured with Likert Scale of 1 to 5	1 Day of the procedure
Secondary	Mean Tissue volume for each sample taken	Length and diameter of tissue samples for cubic centimeters of volume	1 Day of the procedure