Congenital Venous Malformation Clinical Trial
Official title:
Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.
Absolute ethanol has been used "off-label" as an unmodified formulation (solution) in
Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears
difficult to handle because of its high diffusion capacity outside the CVM and in the blood
circulation. A less diffusible ethanol-based product (ethanol gel) has been developed in
order to minimize systemic and local diffusion capacities of ethanol. Therefore, the
pharmacokinetic parameters and their clinical and paraclinical outcomes between ethanol gel
96% and absolute ethanol need to be carried out.
FDA Office of Orphan Products Development (FDA OOPD) : Funding source.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label