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

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Dec 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called electrosclerotherapy for people with low-flow venous malformations, which are abnormal blood vessel formations that can occur at birth. The trial aims to see how effective this method is in reducing these malformations while minimizing side effects. Electrosclerotherapy uses a special agent called Bleomycin to help close off the problematic blood vessels, making it a less invasive option compared to other treatments.

To participate in this trial, individuals must have a diagnosis of low-flow venous malformations and should not have had any other treatments in the past 30 days. It's open to all genders, and participants can be between the ages of 5 and 43. However, pregnant or breastfeeding women and those with certain health issues, like severe lung or kidney problems, cannot join. Participants can expect regular check-ups to monitor their progress and any side effects during the study. This trial is currently recruiting, so if you or someone you know is interested, it's a good opportunity to explore a new treatment option.

Gender

ALL

Eligibility criteria

• 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