Trial Information
Endoscopic Rescetion of High Grade(TA, T1, Cis)Non-muscle Invasive Bladder Tumors: Modification of Usual Management of This Resection by Using the Blue Light and Evaluation of the Outcome: Should we Maintain the Dogma of Second Endoscopic Resection as a Principle?
Inclusion Criteria:
- 18 year-old and older male and female subjects having high grade non-muscle invasive
bladder tumor, with urinary cytology , imaging examination (Ultrasound, urography, or
scan) and endoscopic examination
Exclusion Criteria:
- Less than 18 years of age, and having no:
- Non-muscle invasive tumor, and of low grade.
- Bladder tumor infiltrating the muscular layer shown by pre-operative test, with
absence of urinary cytology
- No blue light source in sustainable way
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of extra lesions revealed by blue light compared to the resection performed in white light
Outcome Time Frame:
2 to 6 weeks after resection
Safety Issue:
No
Principal Investigator
Henry BOTTO, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hôpital FOCH 40, rue Worth 92150 Suresnes
Authority:
France: Direction Générale de la Santé
Study ID:
2009/34
NCT ID:
NCT01750970
Start Date:
November 2009
Completion Date:
February 2013
Related Keywords:
- Bladder Tumor
- Urinary Bladder Neoplasms