Venous Vascular Malformation Clinical Trial
Official title:
Cryoablation of Venous Vascular Malformations Located in Soft Tissues
To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.
In order to propose an additional alternative option, cryoablation has been recently tested
with promising results. Therefore, the purpose of this study is to evaluate the safety and
efficacy of cryotherapy on venous vascular malformations.
Fourteen patients will be included after discussion in multidisciplinary meeting. Patients
will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms.
A MRI will be perform at 6 months to evaluate the size of ablated zone following RECIST
criteria.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment