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

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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