Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Ear… (NCT07555769) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial
20 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety within 3 months post-treatment assessed by adverse and serious adverse events.
Timeframe: From treatment to follow-up after 3 months