Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational S… (NCT06189092) | Clinical Trial Compass
RecruitingNot Applicable
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Italy65 participantsStarted 2023-10-28
Plain-language summary
Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.
Who can participate
Age range
16 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:
* Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
* Non-indication for embolizing treatment
* Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.
Exclusion Criteria:
* Previous treatment for \< 30 days
* Pregnancy and lactation status
* Patients of childbearing age without contraceptive use
* Presence of metal synthetic media
* COPD with FiO2 \< 30 mmHg
* Impaired renal function with eGFR\<30 ml/min/1.73mq
* Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related
* Patients who have already received a cumulative dose of Bleomycin ≥100 mg
* Patients who have undergone prior thoracic radiotherapy
* Patients with a history of seizures and epilepsy
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.