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MRI-Ultrasound Fusion Device
MRI-ultrasound fusion device for Prostate Cancer
N/A
Waitlist Available
Led By Winston Barzell, MD
Research Sponsored by Focal Healthcare Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
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.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of biopsy cores positive for clinically significant cancer.
Secondary outcome measures
Number of men diagnosed with clinically significant and clinically insignificant cancer.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MRI-ultrasound fusion deviceExperimental Treatment1 Intervention
Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging
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Who is running the clinical trial?
Focal Healthcare Inc.Lead Sponsor
Winston Barzell, MDPrincipal Investigator21st Century Oncology, Inc.
Frequently Asked Questions
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