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Treatment of low-flow vascular malformations with bleomycin electrosclerotherapy (BEST)
EU CTIS ID: 2025-524123-45-00
What this study is testing
To determine the efficacy and feasibility of BEST in the treatment of low-flow vascular malformations.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with low-flow vascular malformations (venous, lymphatic, capillary or mixed type malformations),
- Patients with a low-flow vascular malformation poorly responding or recurring after previous treatment(s).
- Technical feasibility of the BEST procedure, i.e.: injection of bleomycin and safe placement of electrodes into the vascular malformation are technically feasible.
- age ≥ 18
- longer lesion diameter not exceeding 25 cm.
- more than one lesion can be treated. The limiting factor is the maximal dose per patient per treatment session; 10 000 IU in adults,
You likely can't join if
- Pregnancy and lactation
- chronic renal dysfunction.
- in adults, previous bleomycin exposure with a cumulative dose greater than 100 000 IU. In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated,
- In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated.
- Known allergy or hypersensitivity to bleomycin.
- Presence of significant central venous drainage precluding sclerotherapy.
See the full eligibility criteria
- Patients with low-flow vascular malformations (venous, lymphatic, capillary or mixed type malformations),
- Patients with a low-flow vascular malformation poorly responding or recurring after previous treatment(s).
- Technical feasibility of the BEST procedure, i.e.: injection of bleomycin and safe placement of electrodes into the vascular malformation are technically feasible.
- age ≥ 18
- longer lesion diameter not exceeding 25 cm.
- more than one lesion can be treated. The limiting factor is the maximal dose per patient per treatment session; 10 000 IU in adults,
- skin or mucosal, superficial or deep-seated lesions can be treted,
- Pregnancy and lactation
- chronic renal dysfunction.
- in adults, previous bleomycin exposure with a cumulative dose greater than 100 000 IU. In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated,
- In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated.
- Known allergy or hypersensitivity to bleomycin.
- Presence of significant central venous drainage precluding sclerotherapy.
- women of childbearing potential and men not using reliable contraceptive,
- acute lung infection or severely reduced lung function,
- bleomycin-related lung toxicity or reduced lung function which can indicate bleomycin-related lung toxicity,
- ataxia telangiectasia,
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.