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Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device

NCT02524860 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-03-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.

Conditions

Interventions

DEVICE

Focal-Fusion Bx

The Focal-Fusion Bx device uses hardware and software to overlay targets onto the live ultrasound image in real-time. This allows the urologist to take biopsy samples from tissue that looked suspicious on the patient's MRI.

Sponsors & Collaborators

  • Focal Healthcare Inc.

    lead INDUSTRY

Principal Investigators

  • Winston Barzell, MD · 21st Century Oncology, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

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 NCT02524860 on ClinicalTrials.gov