Actively Recruiting
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Led by Istituto Ortopedico Rizzoli · Updated on 2024-10-29
65
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, Italy, 40136
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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