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Study to evaluate the efficacy and safety of supportive mitomycin C administered via electric current in the treatment of non-muscle invasive bladder cancer versus the standard immunotherapy.
EU CTIS ID: 2024-520006-19-00
What this study is testing
To evaluate the efficacy of the adjuvant with EMDA-MMC (induction x6 weekly instillations and 1 year of maintenance) compared with the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvant treatment of High Grade NMLCC.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients older than 18 years and life expectancy ≥ 5 years.
- Patients able to give informed consent for the study.
- Patients with primary non-muscle infiltrating urothelial non-muscle metamorphosed (NMIBC), uni- or multi-focal, stages Ta and T1, High Grade (2004 WHO), including old G2 High Grade and all G3.
- Patients treated with optically complete TUR of the tumor and, when indicated by clinical guidelines, RE-RTU that must be performed within the first 6 weeks.
- Negative bladder random biopsies for Tcis
- Presence of own muscle in the TUR and / or in the RE-RTU.
You likely can't join if
- Patients unable to give informed consent for their participation in the study.
- Stage tumors ≥T2.
- cN + and / or cM + tumors.
- Pregnant women.
- Relative contraindications for the use of the EMDA system - Urethral stricture. - Giant prostatic lobe with bladder neck occlusion. - Psychosis - Alcoholism - Active untreated urinary infection
- Patients with a history of allergic reactions to BCG or MMC.
See the full eligibility criteria
- Patients older than 18 years and life expectancy ≥ 5 years.
- Patients able to give informed consent for the study.
- Patients with primary non-muscle infiltrating urothelial non-muscle metamorphosed (NMIBC), uni- or multi-focal, stages Ta and T1, High Grade (2004 WHO), including old G2 High Grade and all G3.
- Patients treated with optically complete TUR of the tumor and, when indicated by clinical guidelines, RE-RTU that must be performed within the first 6 weeks.
- Negative bladder random biopsies for Tcis
- Presence of own muscle in the TUR and / or in the RE-RTU.
- RE-RTU in all cases of T1 and also in Ta tumors when the initial TUR is incomplete or with absence of muscle in the sample.
- Patients unable to give informed consent for their participation in the study.
- Stage tumors ≥T2.
- cN + and / or cM + tumors.
- Pregnant women.
- Relative contraindications for the use of the EMDA system - Urethral stricture. - Giant prostatic lobe with bladder neck occlusion. - Psychosis - Alcoholism - Active untreated urinary infection
- Patients with a history of allergic reactions to BCG or MMC.
- Patients with pacemakers or DICs
- Previous history of bladder tumors.
- Antecedents of pelvic radiotherapy (bladder, prostate, rectum, vagina, uterus).
- Absence of own muscle in the sample (neither in RTU nor in RE-RTU).
- Patients with stage T1 who have not received RE-RTU.
- Patients with Tcis isolated or associated with papillary tumor.
- Presence of squamous cell carcinoma of the bladder or bladder adenocarcinoma
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.