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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2020-03-11

Brief Summary

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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).

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Detailed Description

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Conditions

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Varicocele Endoleak Portal Vein Thrombosis Bleeding Angiomyolipoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

French multicenter, phase 2b (device), prospective study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Embolization with Easyx

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.

Group Type EXPERIMENTAL

Easyx

Intervention Type DEVICE

Embolization will be done with Easyx liquid agent.

Interventions

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Easyx

Embolization will be done with Easyx liquid agent.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No