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NOT YET RECRUITING
NCT07555769
PHASE1

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

Sponsor: Juan Luis Vásquez

View on ClinicalTrials.gov

Summary

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.

Official title: Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06

Completion Date

2030-04

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

PROCEDURE

Calcium electroporation

Calcium electroporation involves injection of calcium gluconate into the urinary bladder tumor followed by short, electric pulses (electroporation) with the transurethral electrode

DRUG

Intratumoral calcium injection

Intratumoral injection of calcium gluconate in the urinary bladder

DEVICE

Transurethral electroporation

After injection of calcium into tumor, electroporation is applied using the transurethral electrode