Clinical Studies

There are two pivotal studies that show

Cysview is clinically proven to detect bladder cancer that would be missed by White Light Cystoscopy alone.1

Study1

  • A prospective, multicenter, within patient controlled, clinical trial in adult patients with known or suspected bladder cancer who were randomized to either White Light Cystoscopy (WLC) (control group, n=384) or WLC followed by Blue Light Cystoscopy (BLC) (study drug group, n=395).
  • Only the study drug group patients received Cysview by bladder instillation prior to cystoscopy. After bladder evacuation of Cysview, bladder lesion mapping was performed initially using the KARL STORZ PDD system in the white-light mode followed by lesion mapping in the blue-light mode. Control group patients underwent only WLC with lesion mapping.
Cysview makes bladder cancer tumors glow bright pink so more can be seen during cystoscopy and TURBT

Study2

  • A prospective, open-label, within patient controlled, clinical trial using Blue Light Cystoscopy (BLC) with Cysview in the detection of bladder cancer during surveillance cystoscopy. Patients with bladder cancer in follow-up for tumor recurrence (n=304) received Cysview by bladder instillation.
  • After bladder evacuation of Cysview, a standard White Light Cystoscopy (WLC) was performed, followed by BLC with Cysview using the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System with the Flexible PDD Videoscope System. Suspected malignant lesions were counted and evaluated.
  • Patients with suspected recurrence (n=103), underwent a Cysview instillation followed by WLC and BLC with Cysview in the operating room (OR) using the KARL STORZ D-Light C PDD System with the Rigid PDD Cystoscope System. Lesion mapping was also done. The suspicious lesions were biopsied and surgically removed by TURBT.
  • The study’s primary efficacy end point was the proportion of patients with histologically confirmed malignancy that was detected only by BLC and not by WLC in the surveillance setting.
Cysview makes bladder cancer tumors glow bright pink so more can be seen during cystoscopy in surveillance
Cysview makes bladder cancer tumors glow bright pink so more can be seen during cystoscopy and TURBT

Table of Results 1

Bladder Tumor Detection within the Study Drug Group by WL and/or BL Cystoscopy1
Number of lesions Detected by Both WL & BL Detected by WL Only Detected by BL Only
CIS, n = 66 33 6 27
Ta, n = 580 472 52 56
T1, n = 95 76 10 9
T2 - T4, n = 47 38 8 1
Among the lesions detected only by BL, 23% were negative for any carcinoma-related pathology, including dysplasia. Among the lesions detected by only WL, 17% were negative for any carcinoma-related pathology, including dysplasia.

Table of Results 2

Lesion Detection by Type of Malignancy as Verified in the OR
Malignancy Type Detected by Both WL & BL Detected by WL Only Detected by BL Only
CIS, n = 43 24 3 16
Ta, n = 94 61 9 24
T1, n = 10 7 0 3
T2 - T4, n = 5 5 0 0
PUNLMP** n = 3 2 0 1
False positive n = 160 65 22 73
Total number of lesions 164 34 117
** papillary urothelial neoplasm of low malignant potential

1 Stenzl A, Burger M, Fradet Y, et al. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol. 2010;184(5):1907-13.
2 Daneshmand S et al. Efficacy and safety of blue light flexible cystoscopy With Hexaminolevulinate (HAL) in the surveillance of bladder cancer: A phase III, comparative, multi-center study. J Urol. 2017 Dec 2. pii: S0022-5347(17)78004-4. doi: 10.1016/j.juro.2017.11.096. [Epub 2017 Dec 2].