Clinical trial · Interventional
EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Angiomyolipoma | Angiomyolipoma | ONTOLOGY_EXACT | 0.98 |
| Bleeding | — | UNRESOLVED | — |
| Endoleak | — | UNRESOLVED | — |
| Portal Vein Thrombosis | — | UNRESOLVED | — |
| Varicocele | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Easyx | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Embolization with Easyx
- 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.
- interventionNames
- Device: Easyx
Primary outcomes (6)
- measure
- Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety
- timeFrame
- one day
- description
- Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability "certain" or "probable")
- measure
- Efficacy for type 2 endoleaks embolization
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available