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Completed

NCT Number: NCT03477149

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

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).

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Key information

Conditions

Varicocele Aneurysm Angiomyolipoma Bleeding Cardiovascular Diseases Endoleak Genital Diseases Genital Diseases, Male Hemorrhage Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Perivascular Epithelioid Cell Neoplasms Portal Vein Thrombosis Postoperative Complications Postoperative Hemorrhage Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Easyx

Device

Embolization will be done with Easyx liquid agent.

Primary outcomes

  1. 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")

  2. 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).

  3. 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

  4. 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.

  5. 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

  6. 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

  1. SAE

    Time frame: up to 6 months

    Total number of SAE

  2. AE

    Time frame: up to 6 months

    Total number of AE

  3. untargeted embolization

    Time frame: during procedure

    Total number of untargeted embolization

  4. unanticipated ischemia of the target organ

    Time frame: up to 6 months

    Total number of unanticipated ischemia of the target organ

  5. orchi-epididymitis

    Time frame: up to 6 months

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

  6. neural route lesion

    Time frame: up to 6 months

    Total number of neural root lesion (type II endoleaks)

  7. aneurysm rupture

    Time frame: up to 6 months

    Total number of aneurysm rupture (type II endoleaks)

  8. tumor rupture

    Time frame: up to 6 months

    Total number of tumor rupture (angiomyolipoma)

  9. Survival

    Time frame: 6 months

    Survival rates

  10. 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)

  11. 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)

  12. unanticipated use of another liquid agent

    Time frame: during procedure

    Total number of unanticipated use of another liquid agent for embolization

  13. technical success

    Time frame: end of the procedure

    Total number of procedures with immediate technical success

  14. Easyx volume

    Time frame: during procedure

    Mean volume of EASYX™ used during the index procedure

  15. Occlusion

    Time frame: during procedure

    Mean degree of occlusion of the target vessel(s)

  16. Re-intervention

    Time frame: up to 6 months

    Total number of re-intervention for study procedure

  17. Interventional Radiologist (IR) satisfaction

    Time frame: end of the procedure

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

  18. Clinical efficacy

    Time frame: up to 6 months

    Total number of embolization clinical efficacy

  19. 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

  20. Quality of life

    Time frame: up to 6 months

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

  21. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Antia Therapeutics AG

Registry information

Acronym: EASYX-1

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2018
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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