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

October 7, 2020 updated by: Assistance Publique - Hôpitaux de Paris
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75908
        • AP-HP - Hôpital Européen Georges-Pompidou Paris, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Embolization with 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.
Device: Easyx
Embolization will be done with Easyx liquid agent.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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")
one day
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).
6 months
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
Before ablation
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.
1 month
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
3 month
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
Through embolization completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAE
Time Frame: up to 6 months
Total number of SAE
up to 6 months
AE
Time Frame: up to 6 months
Total number of AE
up to 6 months
untargeted embolization
Time Frame: during procedure
Total number of untargeted embolization
during procedure
unanticipated ischemia of the target organ
Time Frame: up to 6 months
Total number of unanticipated ischemia of the target organ
up to 6 months
orchi-epididymitis
Time Frame: up to 6 months
Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)
up to 6 months
neural route lesion
Time Frame: up to 6 months
Total number of neural root lesion (type II endoleaks)
up to 6 months
aneurysm rupture
Time Frame: up to 6 months
Total number of aneurysm rupture (type II endoleaks)
up to 6 months
tumor rupture
Time Frame: up to 6 months
Total number of tumor rupture (angiomyolipoma)
up to 6 months
Survival
Time Frame: 6 months
Survival rates
6 months
Pain
Time Frame: 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)
up to 6 months
Pain improvement
Time Frame: up to 6 months
Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain)
up to 6 months
unanticipated use of another liquid agent
Time Frame: during procedure
Total number of unanticipated use of another liquid agent for embolization
during procedure
technical success
Time Frame: end of the procedure
Total number of procedures with immediate technical success
end of the procedure
Easyx volume
Time Frame: during procedure
Mean volume of EASYX™ used during the index procedure
during procedure
Occlusion
Time Frame: during procedure
Mean degree of occlusion of the target vessel(s)
during procedure
Re-intervention
Time Frame: up to 6 months
Total number of re-intervention for study procedure
up to 6 months
Interventional Radiologist (IR) satisfaction
Time Frame: end of the procedure
Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)
end of the procedure
Clinical efficacy
Time Frame: up to 6 months
Total number of embolization clinical efficacy
up to 6 months
Other liquid embolics
Time Frame: end of the procedure
Total number of procedures with a need to complete with another liquid embolic to achieve optimal result
end of the procedure
Quality of life
Time Frame: up to 6 months
Patient's quality of life (EQ-5D)
up to 6 months
Imaging
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Antia Therapeutics AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K170403J
  • 2017-A02370-53 (Other Identifier: EUDRACT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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