Under construction – not a live service
Sign in

2024-520006-19-00RecruitingPhase 4

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.

Multicenter clinical trial with medical device associated with a drug in an authorised therapeutic use for the treatment of CVNMI evaluating the efficacy and tolerability of the adyuvant treatment with EMDA-MMC versus standard BCG in patients with high grade CVNMI

Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Next steps

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
230 (estimated)
First submitted
16 Dec 2024
Start date
15 Dec 2021
Lead sponsor
Presurgy S.L.
EU CT number
2024-520006-19-00
EudraCT number
2018-004273-27

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 230
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a first high-grade non-muscle invasive bladder cancer (stage Ta or T1) whose tumour was fully removed. It compares MMC given with electric current (EMDA-MMC) to BCG.

Age
Older than 18 years, with a life expectancy of 5 years or more.
Sex
All sexes can join.
Disease stage
First (primary) high-grade non-muscle invasive bladder cancer, stage Ta or T1, one or several tumours. Biopsies of the bladder must be negative for Tcis.
Earlier treatment
The tumour must have been fully removed by TUR, with muscle present in the sample. A repeat TUR within the first 6 weeks is needed when guidelines call for it, and in all T1 cases.

Main reasons for not taking part

  • Tumour of stage T2 or higher, or spread to lymph nodes or other organs
  • Pregnant women
  • Earlier bladder tumour or earlier pelvic radiotherapy
  • Allergic reaction to BCG or MMC in the past
  • Pacemaker or defibrillator (DIC), or carcinoma in situ (Tcis) alone or with a papillary tumour

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of bladder tumors.
  • Antecedents of pelvic radiotherapy (bladder, prostate, rectum, vagina, uterus).
  • Patients with stage T1 who have not received RE-RTU.

Other illness

  • 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.

Other

  • Patients unable to give informed consent for their participation in the study.
  • Stage tumors ≥T2.
  • cN + and / or cM + tumors.
  • Pregnant women.
  • Patients with pacemakers or DICs
  • Absence of own muscle in the sample (neither in RTU nor in RE-RTU).
  • Patients with Tcis isolated or associated with papillary tumor.
  • Presence of squamous cell carcinoma of the bladder or bladder adenocarcinoma

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (20)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Complexo Hospitalario Universitario A CoruñaA CoruñaSpainRecruiting
Hospital Universitario de CrucesBarakaldoSpainRecruiting
Fundació PuigvertBarcelonaSpainRecruiting
Hospital Universitario Puerta del MarCadizSpainRecruiting
Hospital Universitario Del HenaresCosladaSpainRecruiting
Hospital Universitario DonostiaDonostiaSpainRecruiting
Hospital San PedroLogroñoSpainRecruiting
Hospital Universitario Fundación Jiménez DíazMadridSpainRecruiting
Hospital Universitario Ramón y CajalMadridSpainRecruiting
Hospital Universitario La PazMadridSpainRecruiting
University Clinical Hospital Virgen De La ArrixacaMurciaSpainRecruiting
Hospital General Universitario Morales MeseguerMurciaSpainRecruiting
Hospital Universitario Central De AsturiasOviedoSpainRecruiting
Hospital Universitario de NavarraPamplonaSpainRecruiting
Hospital Universitario de CanariasSan Cristóbal de La LagunaSpainRecruiting
Hospital Universitario Marqués de ValdecillaSantanderSpainRecruiting
Hospital 9 De Octubre S.A.ValenciaSpainRecruiting
Fundación Instituto Valenciano de OncologíaValenciaSpainRecruiting
Hospital Universitario Rio HortegaValladolidSpainRecruiting
Hospital Universitario ArabaVitoriaSpainRecruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.