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


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.

Study Start Date

April, 25 2018

Estimated Completion Date

February 2019


  • Device: ClariCore Optical Biopsy System

Study ID

Precision Biopsy, Inc. -- CIP-1010-B



Trial ID


Study Type


Trial Phase


Enrollment Quota



Precision Biopsy, Inc.

Inclusion Criteria

  • Males > 22 years old
  • Patient scheduled for TRUS-guided prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy (abnormal Digital Rectum Examination, Prostate Specific Antigen kinetics, age, ethnicity, family history, etc.)
  • Enrolling physician must have expectation that prostate dimensions will meet minimum prostate volume and height requirements that will be evaluated at start of biopsy procedure (i.e., Prostate volume > 20cc and height at least 22mm)
  • Patient signs an Institutional Review Board approved, Informed Consent form to participate in the study prior to any study mandated determinations or procedure

Exclusion Criteria

  • Any anatomical or co-morbidity contraindications to TRUS prostate biopsy
  • Acute painful perianal disorder (i.e. rectal abscess)
  • Symptomatic, acute prostatitis
  • Surgical absence of a rectum or the presence of a rectal fistula
  • Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
  • Previous prostate intervention [Transurethral Prostatectomy (TURP) (bipolar, monopolar, laser)], Transurethral Microwave Thermotherapy (TUMT), High-Intensity Focused Ultrasound (HIFU), Cryo, Rezum, Urolift], not including previous prostate biopsy
  • Current use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) or history of a bleeding disorder (e.g. coagulopathy)
  • Prior pelvic irradiation
  • Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)
  • Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
  • Patient has compromised immune system
  • Active inflammatory bowel disease within the last 6 months
  • Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)
  • Patient is not likely to comply with the protocol or follow up evaluation
  • Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study
  • Patient is unable to provide legal Informed Consent




22 Years and older

Accepts Healthy Volunteers


Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Memorial SloanKettering Cancer Center - New York, New York 184.8 miles Melissa Salerno BS None
NYU Langone Urology Associates - New York, New York 186.5 miles Elton Llukani None
Brady Urological Institute Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Robin Gurganus RN CCRC 410-614-6926
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles Jennifer Baiden 843-449-1010
Urology of San Antonio - San Antonio, Texas 1,768.2 miles Manuel R Hernandez 210-617-4116
The Urology Center of Colorado - Denver, Colorado 1,768.5 miles Robin Dorsey 303-762-7155 None provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.