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

NCT ID: NCT06189092

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-28
• Study Completion Date: 2027-11-28

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Performed electrosclerotherapy

All patients who performed electrosclerotherapy in the treatment of vascular malformations

Bleomycin

Intervention Type: DRUG

Using electroporation to infuse bleomycin in the lesion

Interventions

Bleomycin

Using electroporation to infuse bleomycin in the lesion

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giancarlo Facchini, MD

Role: primary

giancarlo.facchini@ior.it

+39 333 650 0944

Other Identifiers

CE AVEC: 639/2023/Oss/IOR

Identifier Type: -

Identifier Source: org_study_id