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

Not Applicable

Completed

• Conditions: Varicocele; Angiomyolipoma; Endoleak; Portal Vein Thrombosis; Bleeding
• Interventions: Device: Easyx

• Registration Number: NCT03477149
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Study Start: 2018-03-30
• Primary Completion: 2020-03-11
• Study Completion: 2020-03-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embolization with Easyx	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.

Primary Outcome Measures

Name	Time	Method
Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety	one day	Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability "certain" or "probable")
Efficacy for type 2 endoleaks embolization	6 months	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).
Efficacy for varicocele embolization	1 month	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.
Efficacy for active bleeding embolization	Through embolization completion	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
Efficacy for portal vein embolization	Before ablation	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
Efficacy for angiomyolipoma embolization	3 month	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

Secondary Outcome Measures

Name	Time	Method
Survival	6 months	Survival rates
SAE	up to 6 months	Total number of SAE
unanticipated use of another liquid agent	during procedure	Total number of unanticipated use of another liquid agent for embolization
Imaging	6 months	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
orchi-epididymitis	up to 6 months	Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)
Pain	up to 6 months	Use of Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain)
Pain improvement	up to 6 months	Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain)
Re-intervention	up to 6 months	Total number of re-intervention for study procedure
Clinical efficacy	up to 6 months	Total number of embolization clinical efficacy
Other liquid embolics	end of the procedure	Total number of procedures with a need to complete with another liquid embolic to achieve optimal result
AE	up to 6 months	Total number of AE
Easyx volume	during procedure	Mean volume of EASYX™ used during the index procedure
untargeted embolization	during procedure	Total number of untargeted embolization
unanticipated ischemia of the target organ	up to 6 months	Total number of unanticipated ischemia of the target organ
aneurysm rupture	up to 6 months	Total number of aneurysm rupture (type II endoleaks)
Occlusion	during procedure	Mean degree of occlusion of the target vessel(s)
Quality of life	up to 6 months	Patient's quality of life (EQ-5D)
neural route lesion	up to 6 months	Total number of neural root lesion (type II endoleaks)
tumor rupture	up to 6 months	Total number of tumor rupture (angiomyolipoma)
technical success	end of the procedure	Total number of procedures with immediate technical success
Interventional Radiologist (IR) satisfaction	end of the procedure	Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)

Trial Locations

Locations (1)

AP-HP - Hopital Europeen Georges-Pompidou Paris, France; 🇫🇷 Paris, Ile-de-France, France