ClariCore System Used in Transperineal Prostate Biopsy

Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transperineal Prostate Biopsy for Prostate Tissue Classification Algorithm Development

The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach.

Study Overview

• Status: Suspended
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: ClariCore System

Detailed Description

The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach. Ultrasound images corresponding to each needle insertion and T2-weighted MR scans will be saved for the purpose of further algorithm development that will provide physicians with real time tissue classification in conjunction with location information from the ultrasound imaging.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The James Buchanan Brady Urological Institute and Department of Urology
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Urology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Males per Investigator assessment appropriate for transperineal prostate biopsy
2. Patient scheduled for transperineal prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy
3. Prostate volume > 20cc and length at least 22mm as verified by ultrasound or prostate MRI prior to the procedure
4. Patient must be able to provide legal consent and signs an IRB (Institutional Review Board)/EC (Ethics Committee) approved Informed Consent form to participate in the study prior to any study mandated determinations or procedure

Exclusion Criteria:

1. Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or transperineal prostate mapping biopsy
2. Acute painful perianal disorder (i.e. rectal abscess)
3. Symptomatic, acute prostatitis
4. Surgical absence of a rectum or the presence of a rectal fistula
5. Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
6. Previous prostate intervention [TURP (bipolar, monopolar, laser)] TUMT, HIFU, Cryo, Rezum, Urolift], not including previous prostate biopsy
7. Current required use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) prior to a medical procedure; or history of a bleeding disorder (e.g. coagulopathy)
8. Prior pelvic irradiation
9. 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)
10. Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
11. Patient has compromised immune system, in the opinion of the Investigator
12. Active inflammatory bowel disease within the last 6 months

13. 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)

14. Patient is not likely to comply with the protocol or follow up evaluation
15. Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ClariCore System; Biopsy tissue, correlative spectral data, T2-weighted MR scans and ultrasound images acquired with the ClariCore System will be collected and recorded during standard practice transperineal biopsy.	Device: ClariCore System; The user will perform a standard trans-perineal biopsy and collect a number of biopsy cores as per standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of histopathology of tissue with ultrasound images and spectral data	The correlation of histopathology of tissue biopsy core samples with the corresponding spectral data and ultrasound images obtained in vivo for the purpose of tissue classification algorithm development using a transperineal approach.	At time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (Safety)	The cumulative incidence of adverse events related to the device or the procedure. The cumulative incidence of serious adverse events (SAEs) related to the device or the procedure.	At time of procedure

Collaborators and Investigators

• Sponsor: Precision Biopsy, Inc.
• Investigators: Principal Investigator: James Wysock, MD, NYU Langone Urology Associates

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): July 9, 2019
• Study Completion (Anticipated): July 9, 2019

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CIP-1012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No