Blue Light Cystoscopy With Cysview® Registry

Data will be captured on specific patient types undergoing Blue Light Cystoscopy with

Cysview for known or suspected non-muscle invasive bladder cancer. Specific clinical

questions will be asked.

1. What is the incremental detection rate with Blue Light Cystoscopy with Cysview over

conventional white light cystoscopy in each of the seven (7) patient populations?

Does this translate into lower recurrence/progression rate?

2. How do the six (6) tumor variables used in the European Association of Urology (EAU)

risk tables (primary/secondary, recurrence rate, size, multifocality, grade, and

history of carcinoma in situ (CIS))6 affect this incremental rate?

3. How does an abnormal cytology or positive or negative fluorescent in situ

hybridization (FISH) affect the likelihood that Blue Light Cystoscopy with Cysview

will detect more cancers than white light?

4. What are the performance characteristics of Blue Light Cystoscopy with Cysview

within eight (8) weeks of Bacillus Calmette-Guérin (BCG) with respect to improved

tumor detection and false positive rate compared to conventional white light

cystoscopy?

5. What is the incremental Blue Light Cystoscopy with Cysview detection rate over

random bladder biopsies alone in patients being evaluated for routine three month

restaging (group 4) or occult disease (group 5)?

6. What are the performance characteristics of Blue Light Cystoscopy with Cysview after

repeated Blue Light Cystoscopy with Cysview evaluations with respect to improved

tumor detection, false positive rate and safety compared to conventional white

light?

7. Does an abnormal urinalysis help identify patients with inflammation more likely to

have false positive Blue Light Cystoscopy with Cysview results?

8. What is the practical learning curve for becoming "proficient" with Blue Light

Cystoscopy with Cysview?

9. What is the overall false positive rate with Blue Light Cystoscopy with Cysview?

10. Can Blue Light Cystoscopy with Cysview make the resection more complete? If yes, is

this due to improved margins and/or additional tumors seen under blue light?

11. What are the performance characteristics of BLC™ with Cysview® on patients with

variant histology?

12. How does BLC™ with Cysview® impact detection of tumors in surveillance and patient

management decisions?

13. How does BLC™ with Cysview® impact management of small tumors during office

biopsy/fulguration?

14. How can BLC impact patient selection for bladder cancer sparing drugs?

15. Does the combination of BLC with urine biomarkers guide appropriate therapy and or

change management?

16. Does BL have an impact on long term outcomes such as recurrence or progression?

The Blue Light Cystoscopy with Cysview Registry is a web-based program supported by

Global Vision Technologies. Data will be captured longitudinally over five (5) years on

patients from each enrolled site. Each center will enter their respective site's patient

data electronically.