EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Endoleak; Portal Vein Thrombosis; Varicocele; Angiomyolipoma; Bleeding

Treatments: Device: Easyx

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03477149

K170403J

2017-A02370-53 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient presenting with indication of varicocele, type II endoleaks, portal vein, AML or active embolization with a liquid agent
• Aged ≥ 18 years
• Affiliated to a French health insurance system

Exclusion criteria

• Hypersensitivity to Polyvinyl Alcohol (PVA) Polymer
• Hypersensitivity to DMSO solvent
• Patient unable or unwilling to provide a written informed consent
• Patient participating in another interventional study
• Pregnant or breastfeeding woman
• Prisoners

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Embolization with Easyx

Experimental group

Description:

Patients requiring embolization of varicocele, portal vein before ablation, type 2 endoleak, angiomyolipoma or active bleeding will be treated with the liquid embolic agent Easyx during index procedure.

Treatment:

Device: Easyx