A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting

1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be
included only at the first surveillance cystoscopy after a histologically confirmed
tumor. The histologically confirmed tumor could either be from a TURB or from a
surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by
histology)

2. History of one or more of the following:

- Multiple tumors

- Recurrent tumors

- High grade tumor(s)

Exclusion Criteria:

1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed
resulting in significant amounts of blood in the urine, which may visually limit
cystoscopy. Where the haematuria is light, the patient should not be excluded, if in
the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will
alleviate the haematuria limitations to cystoscopy)

2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training
patients are eligible even if they cannot undergo operating room cystoscopy)

3. Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or
intravesical chemotherapy within the past 6 weeks prior to the procedure

4. Porphyria

5. Known allergy to hexaminolevulinate hydrochloride or a similar compound

6. Pregnancy or breast-feeding (all women of child-bearing potential must document a
negative urine pregnancy test before study inclusion and use adequate contraception
during the study

7. Participation in other clinical studies with investigational drugs either concurrently
or within the last 30 days

8. Patient is the investigator or any sub investigator, research assistant, pharmacist,
study coordinator, other staff or relative thereof directly involved in the conduct of
the protocol

9. Patients that the investigator believes are unlikely to comply with the protocol, e.g.
mental condition rendering the patient unable to understand the nature, scope, and
possible consequences of participating in the clinical study, uncooperative attitude
or unlikelihood of completing the study