About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Previous treatment for < 30 days
Pregnancy and lactation status
Patients of childbearing age without contraceptive use
Presence of metal synthetic media
Trial population
Patients affected by low-flow vascular malformations
Trial design
Cohort
Prospective
Treatments tested in this trial
Bleomycin
DrugUsing electroporation to infuse bleomycin in the lesion
Treatment groups
Trial outcomes
Primary outcomes
Volume reduction in cm
Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.
Secondary outcomes
Reduction of pain (VAS score)
Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
Improvement in quality of life ( EuroQol-5D questionnaire)
Clinical assessment regarding quality of life by EuroQol-5D questionnaire. EQ-5D score can range from -0.594 to 1.0. The minimum value represents the worst possible health condition. The maximum value of 1.0 represents the best possible health condition. A value of 1.0 indicates that the patient has no problem in any of the five dimensions assessed by the questionnaire.
Sponsors and contacts
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