Heart and Blood Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Thrombosis

Venous Thrombosis

Hemorrhage

Varicocele

Endoleak

Angiomyolipoma

Embolism

Embolism and Thrombosis

Vascular Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Aneurysm

Postoperative Hemorrhage

Postoperative Complications

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Perivascular Epithelioid Cell Neoplasms

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.

Embolization will be done with Easyx liquid agent.

Easyx

Marc SAPOVAL, MD, PhD

Romaric LOFFROY, MD, PhD

Vincent VIDAL, MD, PhD

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).

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

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

Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability "certain" or "probable")

Percentage of clinical success. The clinical success of type II endoleaks embolization is defined as the stability or reduction of aneurysm's both anterioposterior and transverse diameters assessed on CT-scan at 6 months compared to baseline (4mm threshold).

Percentage of clinical success before ablation for portal vein embolization. The clinical success of portal vein embolization is defined as the growth ≥15 % of the remnant liver assessed on presurgical CT-scan compared to baseline

Percentage of clinical success for varicocele embolization The clinical success of varicocele embolization is defined as the absence of reflux on ultrasound Doppler at one month follow-up.

Percentage of clinical success for angiomyolipoma embolization. The clinical success of angiomyolipoma embolization is defined as the reduction \>10% of at least one diameter on MRI or CT-scan at 3 months follow-up compared to baseline

Percentage of clinical success for active bleeding embolization The clinical success of active bleeding embolization is defined as the complete occlusion of the target vessel assessed by angiography during the index procedure

Total number of unanticipated ischemia of the target organ

Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)

Total number of neural root lesion (type II endoleaks)

Total number of aneurysm rupture (type II endoleaks)

Total number of tumor rupture (angiomyolipoma)

Use of Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain)

Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain)

Total number of unanticipated use of another liquid agent for embolization

Total number of procedures with immediate technical success

Mean volume of EASYX™ used during the index procedure

Mean degree of occlusion of the target vessel(s)

Total number of re-intervention for study procedure

Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)

Total number of embolization clinical efficacy

Total number of procedures with a need to complete with another liquid embolic to achieve optimal result

Technical success at follow-up assessed on CT-scan for type II endoleaks defined as the ability for the physician to give a diagnosis (absence or minor artifacts) on imaging

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications	NCT03477149	Varicocele Endoleak Portal Vein Thr... Bleeding Angiomyolipoma	Easyx	18 Years -	Assistance Publique - Hôpitaux de Paris
EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications	NCT03477149	Varicocele Endoleak Portal Vein Thr... Bleeding Angiomyolipoma	Easyx	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for endoleak

Every month we try and update this database with for endoleak cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for endoleak

Every month we try and update this database with for endoleak cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for endoleak cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.