Status:
RECRUITING
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Vascular Malformations
Eligibility:
All Genders
16+ years
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 28 2027
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06189092
Start Date
October 28 2023
End Date
November 28 2027
Last Update
October 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, Italy, 40136