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Sponsored by: |
PhotoCure |
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Information provided by: | PhotoCure |
ClinicalTrials.gov Identifier: | NCT00412971 |
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.
The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Official Title: | A Randomized, Comparative Phase III, 2-Center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-Invasive Bladder Cancer |
Estimated Enrollment: | 164 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | September 2008 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Frederiksberg Hospital | |
Frederiksberg, Denmark, 2000 | |
Odense University Hospital | |
Odense, Denmark |
Principal Investigator: | Gregers G Hermann, MD, DM Sci | Frederiksberg Hospital |
Study ID Numbers: | PC B304/04 |
Study First Received: | December 18, 2006 |
Last Updated: | September 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00412971 |
Health Authority: | Denmark: National Board of Health |
Recurrence of bladder cancer Fluorescence cystoscopy |
Cystocele Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms |
Urologic Neoplasms Urinary tract neoplasm Recurrence Bladder neoplasm |
Neoplasms Neoplasms by Site |