ClariCore System Used in Transperineal Prostate Biopsy

NCT03734575 | Suspended FDA Device

• 1 other identifier: CIP-1012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Adverse Events (Safety)

  At time of procedure

Study Arms (1)

ClariCore System

EXPERIMENTAL

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

Interventions

ClariCore System DEVICE

The user will perform a standard trans-perineal biopsy and collect a number of biopsy cores as per standard practice.

ClariCore System

Eligibility Criteria

• Gender Eligibility Details: Males per Investigator assessment appropriate for transperineal prostate biopsy
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males per Investigator assessment appropriate for transperineal prostate biopsy
• Patient scheduled for transperineal prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy
• Prostate volume \> 20cc and length at least 22mm as verified by ultrasound or prostate MRI prior to the procedure
• 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

You may not qualify if:

• Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or transperineal prostate mapping 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 \[TURP (bipolar, monopolar, laser)\] TUMT, HIFU, Cryo, Rezum, Urolift\], not including previous prostate biopsy
• 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)
• 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, in the opinion of the Investigator
• 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

Sponsors & Collaborators

• Precision Biopsy, Inc.: lead

Study Sites (2)

The James Buchanan Brady Urological Institute and Department of Urology

Baltimore, Maryland, 21287, United States

Location

NYU Langone Urology Associates

New York, New York, 10016, United States

Location

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

• James Wysock, MD

  NYU Langone Urology Associates

  PRINCIPAL INVESTIGATOR

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: October 16, 2018
• First Posted: November 8, 2018
• Study Start: October 10, 2018
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)