Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    easyx 1
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03477149
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Antia Therapeutics AG
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).

Condition or disease Intervention/treatment Phase
Varicocele Endoleak Portal Vein Thrombosis Bleeding Angiomyolipoma Device: Easyx Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: French multicenter, phase 2b (device), prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Saefty: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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477149


Contacts
Layout table for location contacts
Contact: Marc SAPOVAL, MD, PhD +33156093740 marc.sapoval2@aphp.fr
Contact: Carole DEAN, PhD +33156093719 carole.dean@aphp.fr

Locations
Layout table for location information
France
AP-HP - Hopital Europeen Georges-Pompidou Paris, France Recruiting
Paris, Ile-de-France, France, 75908
Contact: Marc SAPOVAL, PD, PhD       marc.sapoval2@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Antia Therapeutics AG
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03477149     History of Changes
Other Study ID Numbers: K170403J
2017-A02370-53 ( Other Identifier: EUDRACT number )
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
liquid embolics
Additional relevant MeSH terms:
Layout table for MeSH terms
Angiomyolipoma
Varicocele
Thrombosis
Endoleak
Hemorrhage
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Genital Diseases, Male
Aneurysm
Postoperative Hemorrhage
Postoperative Complications
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Perivascular Epithelioid Cell Neoplasms