ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation (SCORE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03504761|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cellular Diagnosis, Prostate Cancer||Device: ClariCore Optical Biopsy System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||325 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transrectal Ultrasound (TRUS)-Guided Prostate Biopsy for Real-Time Tissue Evaluation|
|Actual Study Start Date :||April 25, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: ClariCore System
ClariCore System study designed to obtain prostate biopsies utilizing real-time tissue classification with the ClariCore Optical Biopsy System.
Device: ClariCore Optical Biopsy System
Demonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification.
Other Name: ClariCore System
- Validation of the tissue classification algorithm [ Time Frame: At time of procedure ]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.
- Sensitivity and Specificity [ Time Frame: At time of procedure ]The sensitivity and specificity of the ClariCore System will be calculated and reported.
- Cancer Detection Rate [ Time Frame: At time of procedure ]The cancer detection per core rate in the Targeted Cores that have been classified as suspicious will be determined and reported.
- Identification of New or Clinically Significant Disease [ Time Frame: At time of procedure, at time of 7 day follow up ]The number of instances where a new or more clinically significant disease (Gleason 7 or greater) is diagnosed during collection of the Targeted Cores compared to the SOC Cores
- Adverse Event Incidence [ Time Frame: Up to 7 days post-procedure ]The cumulative incidence of adverse events related to the device or the procedure.
- Serious Adverse Event [ Time Frame: Up to 7 days post-procedure ]The cumulative incidence of serious adverse events (SAEs) related to the device or the procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504761
|Contact: Amanda K Jonas, B.S.||email@example.com|
|Contact: Sierra Yearsley, B.S.||firstname.lastname@example.org|
|United States, Colorado|
|The Urology Center of Colorado||Recruiting|
|Denver, Colorado, United States, 80211|
|Contact: Robin Dorsey 303-762-7155|
|Principal Investigator: Larry Karsh, MD|
|United States, Maryland|
|Brady Urological Institute, Johns Hopkins Hospital||Not yet recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Robin Gurganus, RN, CCRC 410-614-6926 email@example.com|
|Contact: Leslie Mangold, MS 410-955-2139 firstname.lastname@example.org|
|Principal Investigator: Michael A Gorin, M.D., Ph.D.|
|United States, New York|
|NYU Langone Urology Associates||Recruiting|
|New York, New York, United States, 10016|
|Contact: Elton Llukani Elton.Llukani@nyumc.org|
|Contact: James Wysock, MD James.Wysock@nyumc.org|
|Memorial Sloan-Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10021|
|Contact: Melissa Salerno, BS email@example.com|
|Contact: Tanya Milan, MPH 646-227-2231 firstname.lastname@example.org|
|Principal Investigator: Bafar Edhaie, M.D.|
|United States, South Carolina|
|Carolina Urologic Research Center||Recruiting|
|Myrtle Beach, South Carolina, United States, 29572|
|Contact: Jennifer Baiden 843-449-1010 ext 237 email@example.com|
|Principal Investigator: Neal Shore, MD|
|Sub-Investigator: Kenneth Krzyzaniak, MD|
|United States, Texas|
|Urology of San Antonio||Not yet recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Manuel R Hernandez 210-617-4116 firstname.lastname@example.org|
|Principal Investigator: Daniel Saltzstein, MD|
|Principal Investigator:||Neal Shore, M.D.||Carolina Urologic Research Center/Atlantic Urology Clinics|