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

NCT03477149 | Completed DMC

• 2 other identifiers: K170403J2017-A02370-53
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Varicocele; Endoleak; Portal Vein Thrombosis; Bleeding; Angiomyolipoma

Keywords

liquid embolics

Outcome Measures

Primary Outcomes (6)

• Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety

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

  one day

• Efficacy for type 2 endoleaks embolization

  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).

  6 months

• Efficacy for portal vein embolization

  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

  Before ablation

• Efficacy for varicocele embolization

  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.

  1 month

• Efficacy for angiomyolipoma embolization

  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

  3 month

• Efficacy for active bleeding embolization

  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

  Through embolization completion

Secondary Outcomes (21)

• SAE

  up to 6 months

• AE

  up to 6 months

• untargeted embolization

  during procedure

• unanticipated ischemia of the target organ

  up to 6 months

• orchi-epididymitis

  up to 6 months

Study Arms (1)

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.

Device: Easyx

Interventions

Easyx DEVICE

Embolization will be done with Easyx liquid agent.

Embolization with Easyx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Antia Therapeutics AG: collaborator

Study Sites (1)

AP-HP - Hopital Europeen Georges-Pompidou Paris, France

Paris, Île-de-France Region, 75908, France

Location

MeSH Terms

Conditions

Varicocele; Endoleak; Hemorrhage; Angiomyolipoma

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Aneurysm; Postoperative Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Perivascular Epithelioid Cell Neoplasms

Study Officials

• Marc SAPOVAL, MD, PhD

  AP-HP - Hôpital Européen Georges Pompidou

  PRINCIPAL INVESTIGATOR

• Romaric LOFFROY, MD, PhD

  CHU de Dijon - Hôpital François Mitterand

  PRINCIPAL INVESTIGATOR

• Vincent VIDAL, MD, PhD

  AP-HM - La Timone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: French multicenter, phase 2b (device), prospective study

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 26, 2018
• Study Start: March 30, 2018
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)