NCT06189092

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

Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Malformations

Interventions

Type	Name	Description
DRUG	Bleomycin	Using electroporation to infuse bleomycin in the lesion

Timeline

• Start date: 2023-10-28
• Primary completion: 2026-11-28
• Completion: 2027-11-28
• First posted: 2024-01-03
• Last updated: 2024-10-29

Locations

1 site across 1 country: Italy