ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy
|ClinicalTrials.gov Identifier: NCT02773940|
Recruitment Status : Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: ClariCore System||Not Applicable|
The overall objective of this study is to acquire and analyze spectral data and correlative tissue biopsy cores using the ClariCore System for the purpose of algorithm development.
The system algorithm will be trained to identify real-time in vivo 'Normal' versus 'Suspicious' prostate tissue. The 'Normal' or 'Suspicious' assignment will be based on the optical signal principle component parameters of the measured signal when compared to a threshold to be derived from pathologically known values of suspicious (or possibly cancerous) and normal (or non-cancerous) measurements in prostate tissue.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 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 Radical Retropubic Prostatectomy For Prostate Tissue Classification Algorithm Development|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: ClariCore System
Biopsy tissue and correlative spectral data will be acquired using the ClariCore System during the patient's already scheduled radical retropubic prostatectomy (RRP) surgery.
Device: ClariCore System
Biopsy tissue and correlative spectral data will be acquired using the ClariCore System during a patient's already scheduled radical retropubic prostatectomy (RRP) surgery.
- Optical spectra measurements will be correlated with biopsy tissue core samples in patients with known prostate cancer undergoing radical retropubic prostatectomy surgery to develop a prostate tissue classification database [ Time Frame: Through study completion which ends at time of procedure completion ]
- All adverse events reported during the procedure that are related to the ClariCore System [ Time Frame: Through study completion which ends at time of procedure completion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773940
|United States, Maryland|
|Brady Urological Institute, Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Alan W Partin, M.D., Ph.D.||Johns Hopkins University|
|Principal Investigator:||E. David Crawford, M.D.||University of Colorado, Denver|