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

NCT03504761 | Unknown DMC FDA Device

• 1 other identifier: CIP-1010-B
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Validation of the tissue classification algorithm

  Correlate histopathology of tissue biopsy core samples with the tissue classification algorithm results obtained at the time of the procedure to validate the tissue classification algorithm.

  At time of procedure

Secondary Outcomes (2)

• Sensitivity and Specificity

  At time of procedure

• Cancer Detection Rate

  At time of procedure

Other Outcomes (3)

• Identification of New or Clinically Significant Disease

  At time of procedure, at time of 7 day follow up

• Adverse Event Incidence

  Up to 7 days post-procedure

• Serious Adverse Event

  Up to 7 days post-procedure

Study Arms (1)

ClariCore System

EXPERIMENTAL

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

Device: ClariCore Optical Biopsy System

Interventions

ClariCore Optical Biopsy System DEVICE

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

Also known as: ClariCore System

ClariCore System

Eligibility Criteria

• Age: 22 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Precision Biopsy, Inc.: lead

Study Sites (6)

The Urology Center of Colorado

Denver, Colorado, 80211, United States

RECRUITING

Brady Urological Institute, Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

NYU Langone Urology Associates

New York, New York, 10016, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

NOT YET RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Urology of San Antonio

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Neal Shore, M.D.

  Carolina Urologic Research Center/Atlantic Urology Clinics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda K Jonas, B.S.

CONTACT

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

Sierra Yearsley, B.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 20, 2018
• Study Start: April 25, 2018
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)