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Clinical Trials in the EU / 2025-524123-45-00
Authorised, recruiting Phase II

Treatment of low-flow vascular malformations with bleomycin electrosclerotherapy (BEST)

2025-524123-45-00 · tracked via the Priya Life Science EU tracker
Sponsor
Institute Of Oncology Ljubljana
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Decision date
07/04/2026
Enrollment target
140
Sites
Slovenia

Condition studied

VASCULAR MALFORMATION

Investigational medicinal product(s)

Bleomycin medac15 000 RÜ süstelahuse pulber

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

To evaluate effectiveness of BEST in reducing lesion volume, as measured by MRI 3 months after the treatment in patients with low-flow vascular malformations.

Endpoint detail

Assessment of the effectiveness of BEST 12 months after the treatment., Feasibility of recruitment and treatment according to the Current Operating Procedures, Safety and tolerability: Incidence, severity and relationship of treatment-emergent adverse events classified accordint to MedDRA and graded using CTCEA v5.0, Quality of life: QoL assessment with clinically validated OVAMA questioner.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524123-45-00 on CTIS ↗ ← All trials in the EU