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

Study acronym: BEST
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Jun 30, 2026 to Sep 10, 2026 · Eligibility criteria expanded, about 16 words · 1 more Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 30, 2026 to Sep 10, 2026
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 4 entries
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07579962
Lead Sponsor Institute of Oncology Ljubljana
Collaborators: University Medical Centre Ljubljana
Conditions Vascular Malformations
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov