ClariCore System Used in Transperineal Prostate Biopsy
NCT03734575 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-07-11
Summary
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.
Conditions
Interventions
- DEVICE
-
ClariCore System
The user will perform a standard trans-perineal biopsy and collect a number of biopsy cores as per standard practice.
Sponsors & Collaborators
-
Precision Biopsy, Inc.
lead INDUSTRY
Principal Investigators
-
James Wysock, MD · NYU Langone Urology Associates
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-10
- Primary Completion
- 2019-07-09
- Completion
- 2019-07-09
- FDA Device
- Yes
Countries
- United States
Study Locations
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