Study aim:~To calibrate the CellDetect® device for detecting TCC in urine cytology samples.~Determine the performance of the CellDetect® device in identifying TCC recurrence in patients with a history of TCC using urine cytology samples.~The study includes two parts:~Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.~Part II Prospective, controlled, blinded part to determine the performance of the CellDetect® device in monitoring bladder cancer recurrence in in patients with a history of TCC, using urine cytology samples~* The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.~Part I - up to 200 urine eligible samples Part II - up to 300 urine eligible samples~Endpoints:~To calibrate the CellDetect® device for identifying TCC in urine cytology samples.~To determine the performance of the CellDetect® device in identifying recurrence of TCC in urine samples.
This study includes two semi-consecutive parts:~Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.~Part II Prospective, controlled, blinded part to determine the performance of the CellDetect® device in monitoring bladder cancer recurrence in patients with a history of TCC, using urine cytology samples~The following subjects will be enrolled:~Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.