---
title: "EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications"
nct_id: NCT03477149
overall_status: COMPLETED
phase: NA
sponsor: Assistance Publique - Hôpitaux de Paris
study_type: INTERVENTIONAL
primary_condition: Varicocele
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03477149.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03477149"
ct_last_update_post_date: 2020-10-09
last_seen_at: "2026-05-12T06:43:35.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

**NCT ID:** [NCT03477149](https://clinicaltrials.gov/study/NCT03477149)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Assistance Publique - Hôpitaux de Paris
- **Collaborators:** Antia Therapeutics AG
- **Conditions:** Varicocele, Endoleak, Portal Vein Thrombosis, Bleeding, Angiomyolipoma
- **Start Date:** 2018-03-30
- **Completion Date:** 2020-03-11
- **CT.gov Last Update:** 2020-10-09

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Embolization with Easyx** (EXPERIMENTAL) — 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.

## Interventions

- **Easyx** (DEVICE) — Embolization will be done with Easyx liquid agent.

## Primary Outcomes

- **Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety** _(time frame: one day)_ — Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability "certain" or "probable")
- **Efficacy for type 2 endoleaks embolization** _(time frame: 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 portal vein embolization** _(time frame: 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 varicocele embolization** _(time frame: 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 angiomyolipoma embolization** _(time frame: 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
- **Efficacy for active bleeding embolization** _(time frame: 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

## Secondary Outcomes

- **SAE** _(time frame: up to 6 months)_
- **AE** _(time frame: up to 6 months)_
- **untargeted embolization** _(time frame: during procedure)_
- **unanticipated ischemia of the target organ** _(time frame: up to 6 months)_
- **orchi-epididymitis** _(time frame: up to 6 months)_
- **neural route lesion** _(time frame: up to 6 months)_
- **aneurysm rupture** _(time frame: up to 6 months)_
- **tumor rupture** _(time frame: up to 6 months)_
- **Survival** _(time frame: 6 months)_
- **Pain** _(time frame: up to 6 months)_
- **Pain improvement** _(time frame: up to 6 months)_
- **unanticipated use of another liquid agent** _(time frame: during procedure)_
- **technical success** _(time frame: end of the procedure)_
- **Easyx volume** _(time frame: during procedure)_
- **Occlusion** _(time frame: during procedure)_
- **Re-intervention** _(time frame: up to 6 months)_
- **Interventional Radiologist (IR) satisfaction** _(time frame: end of the procedure)_
- **Clinical efficacy** _(time frame: up to 6 months)_
- **Other liquid embolics** _(time frame: end of the procedure)_
- **Quality of life** _(time frame: up to 6 months)_
- **Imaging** _(time frame: 6 months)_

## Locations (1)

- AP-HP - Hopital Europeen Georges-Pompidou Paris, France, Paris, Île-de-France Region, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ap-hp - hopital europeen georges-pompidou paris, france|paris|île-de-france region|france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03477149.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03477149*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*