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NOT YET RECRUITING
NCT07579962
PHASE2

Treatment of Low-flow Vascular Malformations With Bleomycin Electrosclerotherapy (BEST)

Sponsor: Institute of Oncology Ljubljana

View on ClinicalTrials.gov

Summary

In biomedical applications, electroporation is used not only for cancer treatment but also for vaccinations, treatment of cardiac arrhythmias and, more recently, for the treatment of vascular malformations. Bleomycin is a frequently used sclerosing agent in the treatment of various vascular malformations. The use of electrical pulses in addition to bleomycin increases the effectiveness of the treatment, similar to electrochemotherapy. Bleomycin electrosclerotherapy (BEST) is a new treatment modality that is effective in the treatment of low-flow malformations (venous and lymphatic malformations) and potentially also high-flow malformations (arteriovenous malformations). Although a limited number of reports have been published to date, more and more centers are using BEST for the treatment of vascular malformations. As part of the International Network for Sharing Practices on Electrochemotherapy (InspECT) consortium, a dedicated working group has been set up to develop standard operating procedures for BEST. Current Operating Procedures have been prepared and will be used in this clinical trial.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-06-30

Completion Date

2032-06-30

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

DRUG

Bleomycin Sulfate

Bleomycin will be administered by local intralesional injection into the vascular malformation, followed by application of electrical pulses.