A Randomized, Comparative Phase III, 2-Center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-Invasive Bladder Cancer
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted
Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with
suspicion of non-invasive bladder cancer.
Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen
is according to standard clinical practice in Denmark.
Recurrence of non-invasive bladder cancer is frequent, and this study is designed to
investigate whether Hexvix assisted TURB can reduce the early recurrence compared to
standard TURB
Observational
Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective
Gregers G Hermann, MD, DM Sci
Principal Investigator
Frederiksberg Hospital
Denmark: National Board of Health
PC B304/04
NCT00412971
April 2005
September 2008
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