Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial

This phase I study evaluates intravesical calcium electroporation (CaEP) with a new transurethral electrode. The study is primarily designed to assess the safety of CaEP and secondarily, to preliminary explore the efficacy in patients with limited alternative therapies. The anticipated benefits and structured safety precautions justify the ethical conduct of the investigation.

Trial Details

NCT ID

NCT07555769

Phase

PHASE1

Sponsor

Juan Luis Vásquez

Status

RECRUITING

Cancer Type

Bladder Cancer

Interventions

Calcium electroporation
Intratumoral calcium injection
Transurethral electroporation

Locations (sample)

Roskilde, Denmark|55.64152,12.08035

Key Eligibility Criteria

Age ≥ 18 years and able to understand participant information and give informed consent
Histologically verified urothelial bladder tumor
Unfit for cystectomy and/or radiotherapy
Patients with recurrence after radiotherapy unfit for salvage cystectomy

For full eligibility, visit ClinicalTrials.gov.

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