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Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transperineal Prostate Biopsy for Prostate Tissue Classification Algorithm Development
The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach.
The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach. Ultrasound images corresponding to each needle insertion and T2-weighted MR scans will be saved for the purpose of further algorithm development that will provide physicians with real time tissue classification in conjunction with location information from the ultrasound imaging.
Age
All ages
Sex
MALE
Healthy Volunteers
No
The James Buchanan Brady Urological Institute and Department of Urology
Baltimore, Maryland, United States
NYU Langone Urology Associates
New York, New York, United States
Start Date
October 10, 2018
Primary Completion Date
July 9, 2019
Completion Date
July 9, 2019
Last Updated
July 11, 2019
60
ESTIMATED participants
ClariCore System
DEVICE
Lead Sponsor
Precision Biopsy, Inc.
NCT05691465
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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