Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorIstituto Ortopedico Rizzoli

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

Qualifiers

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 design

Treatments tested in this trial

  • Bleomycin

Treatment groups

65 Participants
are divided into 1 treatment group

Sponsors and collaborators