NCT04982536

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Uro-1 Medical · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	VMCore Biopsy System	Prostate Examine
DEVICE	Standard of Care Biopsy Needle	Prostate Examine

Timeline

• Start date: 2020-07-19
• Primary completion: 2022-07-01
• Completion: 2022-08-01
• First posted: 2021-07-29
• Last updated: 2021-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study