NCT02928640

Brief Summary

The purpose of the study is to collect information on prostrate biopsy tissue for use in developing a method determining the difference in normal and cancerous prostrate tissue using the ClariCore System.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3.3 years

First QC Date

October 4, 2016

Last Update Submit

February 13, 2019

Conditions

Cellular Diagnosis, Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Primary Effectiveness

    Correlate histopathology of tissue biopsy core samples with corresponding spectral data obtained in vivo for algorithm training at time of procedure.

    Ath the time of procedure

Secondary Outcomes (2)

  • Assessment of Pain

    Up to 30 days post-procedure

  • Incidence and frequency of adverse events

    Up to 30 days post-procedure

Other Outcomes (3)

  • Technical Success

    Until clinical study closure, at time of 30 day follow up

  • Clinical Success

    Until clinical study closure, at time of 30 day follow up

  • Negative Predictive Value

    Until clinical trial closure, at time of 30 days follow up

Study Arms (1)

ClariCore System

EXPERIMENTAL

ClairCore System study designed for data collection to build the prostrate tissue classification algorithm.

Device: ClariCore System

Interventions

ClariCore SystemDEVICE

Data collection to build the prostrate tissue classification algorithm.

Also known as: ClariCore Optical Biopsy System
ClariCore System

Eligibility Criteria

Age22 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient scheduled for TRUS-guided prostrate biopsy with or without MR TRUS Fusion determined based on standard of care requirements
  • Prostrate volume ≥ 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or prostrate MRI
  • Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure

You may not qualify if:

  • Contraindications to TRUS prostrate biopsy
  • Acute painful perianal disorder
  • Surgical absence of a rectum or the presence of a rectal fistula
  • Patients with contraindications to MRI (e.g., pacemaker, claustrophobia, etc.) (MR/TRUS only)
  • Patients with renal dysfunction are excluded due to their inability to undergo contrast enhanced MRI
  • Previous prostrate surgeries
  • Prior pelvic irradiation
  • 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 has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
  • Bladder cancer (current or prior)
  • Symptomatic acute prostatitis
  • Actively taking blood thinning agents (with the exception of low dose aspirin \[81 mg\] Plavix, Coumadin, etc.) or severe comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g., coagulopathy
  • Any malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 years
  • Hormone therapy for locally advanced disease (except patients on 5-alpha reductase inhibitors to reduce the size of the prostrate)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Johns Hopkins Brady Urological Institute- The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Comprehensive Urology

Royal Oak, Michigan, 48073, United States

Location

Associated Professionals of New York, PLLC

Syracuse, New York, 13210, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Sierra Yearly

    Sponsor GmbH

    STUDY DIRECTOR

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 4, 2016

First Posted

October 10, 2016

Study Start

September 1, 2016

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(5)