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

Description

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

Interventions

  • Device: ClariCore Optical Biopsy System

Study ID

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

Status

Unknown

Trial ID

NCT03504761

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

325

Sponsor

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

Gender

Male

Ages

22 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Memorial SloanKettering Cancer Center - New York, New York 48.5 miles Melissa Salerno BS None salernom@mskcc.org
NYU Langone Urology Associates - New York, New York 50.2 miles Elton Llukani None Elton.Llukani@nyumc.org
Brady Urological Institute Johns Hopkins Hospital - Baltimore, Maryland 219.6 miles Robin Gurganus RN CCRC 410-614-6926 rgurganus@jhmi.edu
Carolina Urologic Research Center - Myrtle Beach, South Carolina 599.5 miles Jennifer Baiden 843-449-1010 jbaiden@atlanticurologyclinics.com
Urology of San Antonio - San Antonio, Texas 1,635.9 miles Manuel R Hernandez 210-617-4116 manuel.hernandez@urologysa.com
The Urology Center of Colorado - Denver, Colorado 1,667.1 miles Robin Dorsey 303-762-7155 None

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