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ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation

NCT03504761 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2019-02-15

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification.

Conditions

  • Cellular Diagnosis, Prostate Cancer

Interventions

DEVICE

ClariCore Optical Biopsy System

Demonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification.

Sponsors & Collaborators

  • Precision Biopsy, Inc.

    lead INDUSTRY

Principal Investigators

  • Neal Shore, M.D. · Carolina Urologic Research Center/Atlantic Urology Clinics

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2020-01-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03504761 on ClinicalTrials.gov