Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology
1. Calibrate the CellDetect® device for detecting bladder cancer (TCC) in urine cytology
2. Determine the feasibility of CellDetect® device to detect bladder cancer in urine
The study includes two parts: Open label calibration part and prospective blinded part to
determine the feasibility of CellDetect® device to identify bladder cancer in urine cytology
* The following subjects will be enrolled:
- Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance
- Subjects undergoing TURTor Cystectomy procedures
Part I - up to 100 urine eligible samples Part II - up to 200 urine eligible samples
1. Calibrate the CellDetect® device for identifying TCC in urine cytology.
2. Show reproducibility and performance of the calibrated product in urine cytology
3. Provide preliminary data showing the feasibility of CellDetect® device to correctly
identify TCC in urine samples.
Observational Model: Cohort, Time Perspective: Prospective
Israel: Ethics Commission