Evaluation of the mitomicin administration, in patients with non-muscle invasive bladder cancer, using electromotive instillation (EMDA).
- Conditions
- Impact of the mitomicin-C (MMC) preoperative administration in patients with primary urothelialnon-muscle invasive bladder cancer (TVNMI) using electromotive instillation (EMDA). Prospective randomised study.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003680-11-ES
- Lead Sponsor
- PRESURGY S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
INCLUSION CRITERIA ( Please refer to Spanish version below)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 123
Exclusion Criteria
EXCLUSION CRITERIA ( Please refer to Spanish version below)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Refer to Spanish version below.;Secondary Objective: Refer to Spanish version below.;Primary end point(s): END POINTS ( Please refer to Spanish version below);Timepoint(s) of evaluation of this end point: 60 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary points ( Please refer to Spanish version below);Timepoint(s) of evaluation of this end point: 60 months