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Assessment of VMCore Biopsy Versus Standard of Care Biopsy

NCT04982536 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-29

No results posted yet for this study

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

Interventions

DEVICE

VMCore Biopsy System

Prostate Examine

DEVICE

Standard of Care Biopsy Needle

Prostate Examine

Sponsors & Collaborators

  • Uro-1 Medical

    lead INDUSTRY

Principal Investigators

  • Thomas Lawson · Uro-1 Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-19
Primary Completion
2022-07-01
Completion
2022-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982536 on ClinicalTrials.gov