Assessment of VMCore Biopsy Versus Standard of Care Biopsy

Not Applicable

• Conditions: Prostate Cancer

• Registration Number: NCT04982536
• Lead Sponsor: Uro-1 Medical

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.

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 Timeline

• Study Start: 2020-07-19
• Status Verified: 2021-07
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-07-29
• Last Update Posted: 2021-07-29
• Primary Completion: 2022-07-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Tissue volume for each sample taken	1 Day of the procedure	Length and diameter of tissue samples for cubic centimeters of volume

Trial Locations

Locations (1)

Georgia Urology; 🇺🇸 Cartersville, Georgia, United States