Recruiting

ClariCore System

Sponsor:

Precision Biopsy, Inc.

Code:

NCT03504761

Conditions

Cellular Diagnosis, Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 22+

Healthy Volunteers: Not accepted

Interventions

ClariCore Optical Biopsy System

Study Details

Brief 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

Study ID

NCT03504761

Start date

Apr 25, 2018

Status verified date

Feb, 2019

Completion date

Dec, 2020

Anticipated

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

325 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: ClariCore System

ClariCore System study designed to obtain prostate biopsies utilizing real-time tissue classification with the ClariCore Optical Biopsy System.

Interventions

ClariCore Optical Biopsy System

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

Primary outcome measure

  • Validation of the tissue classification algorithm [ Time Frame: At time of procedure ]

Central Contacts and Locations

Central contacts

Amanda K Jonas, B.S.

510-676-0904amanda.jonas@precisionbiopsy.com

Sierra Yearsley, B.S.

650-867-0927sierra.yearsley@precisionbiopsy.com

Locations

The Urology Center of Colorado

Recruiting

Denver, Colorado, United States, 80211

Contacts

Robin Dorsey

303-762-7155

Principal Investigator:

Larry Karsh, MD

NYU Langone Urology Associates

Recruiting

New York, New York, United States, 10016

Contacts

Elton Llukani

Elton.Llukani@nyumc.org

James Wysock, MD

James.Wysock@nyumc.org

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contacts

Jennifer Baiden

843-449-1010jbaiden@atlanticurologyclinics.com

Principal Investigator:

Neal Shore, MD

More Information

Sponsor

Precision Biopsy, Inc.

Last update posted

Feb 15, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Precision Biopsy, Inc. on 2019-02-15.