Status:
COMPLETED
EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Antia Therapeutics AG
Conditions:
Varicocele
Endoleak
Eligibility:
All Genders
18+ years
Phase:
NA
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 embo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03477149
Start Date
March 30 2018
End Date
March 11 2020
Last Update
October 9 2020
Active Locations (1)
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1
AP-HP - Hopital Europeen Georges-Pompidou Paris, France
Paris, Île-de-France Region, France, 75908