* 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.
Study aim: 1. To calibrate the CellDetect® device for detecting TCC in urine cytology samples. 2. 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: 1. To calibrate the CellDetect® device for identifying TCC in urine cytology samples. 2. To determine the performance of the CellDetect® device in identifying recurrence of TCC in urine samples.
Study Type
OBSERVATIONAL
Enrollment
500
Emek Medical Center
Afula, Israel
NOT_YET_RECRUITINGUrology Department, Bnai Zion Medical Center
Haifa, Israel
RECRUITINGUrology Department, Hadassah Medical Center Ein Kerem
Jerusalem, Israel
RECRUITINGUrology Department, Meir Medical Center
Kfar Saba, Israel
RECRUITINGUrology Department, Rabin Medical Center, Belinson Campus
Petah Tikva, Israel
RECRUITINGUrology Department, Sourasky Medical Center
Tel Aviv, Israel
RECRUITINGUrology Department, Sheba Medical Center
Tel Litwinsky, Israel
RECRUITINGThis platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.