NCT07555769 Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial
| NCT ID | NCT07555769 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Juan Luis Vásquez |
| Condition | Bladder Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-10-12 |
| Primary Completion | 2030-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-10-12 with a primary completion date of 2030-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion 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 * Disease where other treatments are considered unsuitable or have been declined by the patient * The patient may receive simultaneous systemic treatment * Selected high-burden non-muscle-invasive bladder tumors after MDT assessment * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 * Life expectancy of ≥ 3 months * Patients must be deemed able to tolerate general anesthesia * Sexually active participants in the reproductive age must use contraception. Accepted contraception includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization * Patients must stop treatment with anticoagulants before surgery in accordance with national guidelines * Plasma ionized Ca2+ must be within the normal upper limit. Correction is allowed * Hematology * Thrombocytes ≥ 50 billion/L * International normalized ratio (INR) ≤ 1.5. Correction is allowed Exclusion Criteria: * Pregnancy (confirmed by a blood sample) or lactation * Allergy to calcium gluconate or any of its excipients * Any clinical condition or previous treatment, that in the investigators' opinion made the patient ineligible * Contraindications to treatment with calcium gluconate as described: * Hypersensitivity to calcium gluconate or any of its excipients * Hypercalcemia (e.g. due to hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilization osteoporosis, sarcoidosis, milk-alkali syndrome)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07555769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07555769 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07555769 currently recruiting?
Yes, NCT07555769 is actively recruiting participants. Contact the research team at julv@regsj.dk for enrollment information.
Where is the NCT07555769 trial being conducted?
This trial is being conducted at Roskilde, Denmark.
Who is sponsoring the NCT07555769 clinical trial?
NCT07555769 is sponsored by Juan Luis Vásquez. The trial plans to enroll 20 participants.