Clinical trial NCT03477149: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicocele
Endoleak
Portal Vein Thrombosis
Bleeding
Angiomyolipoma
Keywords: liquid embolics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Antia Therapeutics AG
First posted: 2018-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: French multicenter, phase 2b (device), prospective study
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety
timeFrame: one day
measure: Efficacy for type 2 endoleaks embolization
timeFrame: 6 months
measure: Efficacy for portal vein embolization
timeFrame: Before ablation
measure: Efficacy for varicocele embolization
timeFrame: 1 month
measure: Efficacy for angiomyolipoma embolization
timeFrame: 3 month
measure: Efficacy for active bleeding embolization
timeFrame: Through embolization completion
Secondary outcomes:
measure: SAE
timeFrame: up to 6 months
measure: AE
timeFrame: up to 6 months
measure: untargeted embolization
timeFrame: during procedure
measure: unanticipated ischemia of the target organ
timeFrame: up to 6 months
measure: orchi-epididymitis
timeFrame: up to 6 months
measure: neural route lesion
timeFrame: up to 6 months
measure: aneurysm rupture
timeFrame: up to 6 months
measure: tumor rupture
timeFrame: up to 6 months
measure: Survival
timeFrame: 6 months
measure: Pain
timeFrame: up to 6 months
measure: Pain improvement
timeFrame: up to 6 months
measure: unanticipated use of another liquid agent
timeFrame: during procedure
measure: technical success
timeFrame: end of the procedure
measure: Easyx volume
timeFrame: during procedure
measure: Occlusion
timeFrame: during procedure
measure: Re-intervention
timeFrame: up to 6 months
measure: Interventional Radiologist (IR) satisfaction
timeFrame: end of the procedure
measure: Clinical efficacy
timeFrame: up to 6 months
measure: Other liquid embolics
timeFrame: end of the procedure
measure: Quality of life
timeFrame: up to 6 months
measure: Imaging
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Hopital Europeen Georges-Pompidou Paris, France
state: Ile-de-France
Study officials:
affiliation: AP-HP - Hôpital Européen Georges Pompidou
name: Marc SAPOVAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Dijon - Hôpital François Mitterand
name: Romaric LOFFROY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HM - La Timone
name: Vincent VIDAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: