A Multi-Centre, international study to compare use of Narrow Band Imaging (NBI) versus White light Imaging (WLI) during TURBT to assess recurrence of bladder cancer in terms of safety and efficacy.
Not Applicable
- Conditions
- non muscle-invasive bladder cancer (NMIBC)
- Registration Number
- JPRN-UMIN000004545
- Lead Sponsor
- CROES(Clinical Research Office of the Endourological Society)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 980
Inclusion Criteria
Not provided
Exclusion Criteria
Gross hematuria at the time of TURB. (Note: Gross hematuria is defined as a heavy bladder bleeding resulting in marked amounts of blood in the urine, which may interfere with cystoscopy). Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter). Why, we do not inject anything
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All lesions must be histological confirmed. The proportion of subjects with histology-confirmed tumours (Ta or T1) who have at least one such tumor found by NBI but not by white light cystoscopy. Comparison of the proportions of Group A and Group B subjects who undergo TURB for a histology-confirmed Ta or T1 tumour who have a recurrence (histology confirmed Ta or T1) found at either three or twelve months.
- Secondary Outcome Measures
Name Time Method