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Brief Title: EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications
Official Title: EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications
Study ID: NCT03477149
Brief Summary: The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been used in humans a few time for type II endoleaks, portal vein and varicocele (\<10 cases at the date of submission). The purpose of this study is to evaluate the safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AP-HP - Hopital Europeen Georges-Pompidou Paris, France, Paris, Ile-de-France, France
Name: Marc SAPOVAL, MD, PhD
Affiliation: AP-HP - Hôpital Européen Georges Pompidou
Role: PRINCIPAL_INVESTIGATOR
Name: Romaric LOFFROY, MD, PhD
Affiliation: CHU de Dijon - Hôpital François Mitterand
Role: PRINCIPAL_INVESTIGATOR
Name: Vincent VIDAL, MD, PhD
Affiliation: AP-HM - La Timone
Role: PRINCIPAL_INVESTIGATOR