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Optical Biopsy System

ClariCore System for Prostate Cancer (SCORE Trial)

N/A
Waitlist Available
Led By Neal Shore, M.D.
Research Sponsored by Precision Biopsy, 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 up to 7 days post-procedure
Awards & highlights

SCORE Trial 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.

Eligible Conditions
  • Prostate Cancer

SCORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Validation of the tissue classification algorithm
Secondary outcome measures
Cancer Detection Rate
Sensitivity and Specificity
Other outcome measures
Adverse Event Incidence
Identification of New or Clinically Significant Disease
Serious Adverse Event

SCORE Trial Design

1Treatment groups
Experimental Treatment
Group I: ClariCore SystemExperimental Treatment1 Intervention
ClariCore System study designed to obtain prostate biopsies utilizing real-time tissue classification with the ClariCore Optical Biopsy System.

Find a Location

Who is running the clinical trial?

Precision Biopsy, Inc.Lead Sponsor
3 Previous Clinical Trials
360 Total Patients Enrolled
2 Trials studying Prostate Cancer
160 Patients Enrolled for Prostate Cancer
Neal Shore, M.D.Principal InvestigatorCarolina Urologic Research Center/Atlantic Urology Clinics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation
2018. "ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03504761.
~47 spots leftby Apr 2025
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