Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Recruiting now
Conditions studied: Vascular Malformations
In brief
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.
Key facts
- Study ID
- NCT06189092
- Run by
- Istituto Ortopedico Rizzoli
- People needed
- 65
- Starts
- 2023-10-28
- Expected to finish
- 2027-11-28
- Last updated by the study team
- 2026-05-22
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- Istituto Ortopedico Rizzoli — Bologna, Emilia-Romagna, Italy (enrolling)
Full record on ClinicalTrials.gov
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