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VaricoceleEASYX-1NCT03477149

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

A study testing Easyx in people with Varicocele and Endoleak, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Varicocele, Endoleak, Portal Vein Thrombosis
What is being tested?
Easyx
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
30 Mar 2018to 11 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Paris, Île-de-France Region, 75908

Other trials in France

About this study

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).

Being tested
Easyx
Keywords
liquid embolics
Medical subject headings
Varicocele, Endoleak, Hemorrhage, Angiomyolipoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EasyxDevice

    Embolization will be done with Easyx liquid agent.

Study groups in NCT03477149
Study groupRoleWhat they receive
Embolization with EasyxExperimentalPatients 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.
Receives: Device: Easyx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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")

    Measured: one day

  2. 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).

    Measured: 6 months

  3. 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

    Measured: Before ablation

  4. 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.

    Measured: 1 month

  5. 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

    Measured: 3 month

  6. 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

    Measured: Through embolization completion

Secondary outcomes (21)

  1. SAE

    Total number of SAE

    Measured: up to 6 months

  2. AE

    Total number of AE

    Measured: up to 6 months

  3. untargeted embolization

    Total number of untargeted embolization

    Measured: during procedure

  4. unanticipated ischemia of the target organ

    Total number of unanticipated ischemia of the target organ

    Measured: up to 6 months

  5. orchi-epididymitis

    Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)

    Measured: up to 6 months

  6. neural route lesion

    Total number of neural root lesion (type II endoleaks)

    Measured: up to 6 months

  7. aneurysm rupture

    Total number of aneurysm rupture (type II endoleaks)

    Measured: up to 6 months

  8. tumor rupture

    Total number of tumor rupture (angiomyolipoma)

    Measured: up to 6 months

  9. Survival

    Survival rates

    Measured: 6 months

  10. Pain

    Use of Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain)

    Measured: up to 6 months

  11. Pain improvement

    Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain)

    Measured: up to 6 months

  12. unanticipated use of another liquid agent

    Total number of unanticipated use of another liquid agent for embolization

    Measured: during procedure

  13. technical success

    Total number of procedures with immediate technical success

    Measured: end of the procedure

  14. Easyx volume

    Mean volume of EASYX™ used during the index procedure

    Measured: during procedure

  15. Occlusion

    Mean degree of occlusion of the target vessel(s)

    Measured: during procedure

  16. Re-intervention

    Total number of re-intervention for study procedure

    Measured: up to 6 months

  17. Interventional Radiologist (IR) satisfaction

    Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)

    Measured: end of the procedure

  18. Clinical efficacy

    Total number of embolization clinical efficacy

    Measured: up to 6 months

  19. Other liquid embolics

    Total number of procedures with a need to complete with another liquid embolic to achieve optimal result

    Measured: end of the procedure

  20. Quality of life

    Patient's quality of life (EQ-5D)

    Measured: up to 6 months

  21. Imaging

    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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2018
  2. Study start30 Mar 2018
  3. Primary completion11 Mar 2020
  4. Study completion11 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
French multicenter, phase 2b (device), prospective study
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03477149
Sponsor's protocol ID
K170403J
Other IDs
2017-A02370-53
Acronym
EASYX-1
Status last verified
Oct 2020
First submitted
9 Mar 2018
Last updated
9 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Easyx in people with Varicocele and Endoleak, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety (time frame: one day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03477149.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

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