MedTrace Logo

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

NCT07579962 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Vascular Malformations

Interventions

DRUG

Bleomycin Sulfate

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

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    collaborator OTHER

  • Institute of Oncology Ljubljana

    lead OTHER

Principal Investigators

  • Gregor Serša · Institute of Oncology Ljubljana

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2031-06-30
Completion
2032-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579962 on ClinicalTrials.gov