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Clinical Trials in Italy / NCT06189092
Recruiting Observational

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

NCT06189092 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Observational
Started
2023-10-28
Last updated
2026-05-22

Condition(s) studied

Vascular Malformations

Investigational drug(s) / intervention(s)

Bleomycin →

Bleomycin: Using electroporation to infuse bleomycin in the lesion

Study summary

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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Previous treatment for \< 30 days * Pregnancy and lactation status * Patients of childbearing age without contraceptive use * Presence of metal synthetic media * COPD with FiO2 \< 30 mmHg * Impaired renal function with eGFR\<30 ml/min/1.73mq * Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related * Patients who have already received a cumulative dose of Bleomycin ≥100 mg * Patients who have undergone prior thoracic radiotherapy * Patients with a history of seizures and epilepsy

Primary outcome measure(s)

  • Volume reduction in cm — 1 year
    Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Emilia-Romagna Recruiting

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Official registry record

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

View NCT06189092 on ClinicalTrials.gov ↗ ← All trials in Italy