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

Bleeding Clinical Trial

— EASYX-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477149
• Other study ID #: K170403J
• Secondary ID: 2017-A02370-53
• Status: Completed
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: March 11, 2020

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angiomyolipoma
• Bleeding
• Endoleak
• Portal Vein Thrombosis
• Thrombosis
• Varicocele

Intervention

Device:
• Easyx
Embolization will be done with Easyx liquid agent.

Locations

Country	Name	City	State
France	AP-HP - Hopital Europeen Georges-Pompidou Paris, France	Paris	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Antia Therapeutics AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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")	one day
Primary	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).	6 months
Primary	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	Before ablation
Primary	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.	1 month
Primary	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	3 month
Primary	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	Through embolization completion
Secondary	SAE	Total number of SAE	up to 6 months
Secondary	AE	Total number of AE	up to 6 months
Secondary	untargeted embolization	Total number of untargeted embolization	during procedure
Secondary	unanticipated ischemia of the target organ	Total number of unanticipated ischemia of the target organ	up to 6 months
Secondary	orchi-epididymitis	Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)	up to 6 months
Secondary	neural route lesion	Total number of neural root lesion (type II endoleaks)	up to 6 months
Secondary	aneurysm rupture	Total number of aneurysm rupture (type II endoleaks)	up to 6 months
Secondary	tumor rupture	Total number of tumor rupture (angiomyolipoma)	up to 6 months
Secondary	Survival	Survival rates	6 months
Secondary	Pain	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
Secondary	Pain improvement	Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain)	up to 6 months
Secondary	unanticipated use of another liquid agent	Total number of unanticipated use of another liquid agent for embolization	during procedure
Secondary	technical success	Total number of procedures with immediate technical success	end of the procedure
Secondary	Easyx volume	Mean volume of EASYX™ used during the index procedure	during procedure
Secondary	Occlusion	Mean degree of occlusion of the target vessel(s)	during procedure
Secondary	Re-intervention	Total number of re-intervention for study procedure	up to 6 months
Secondary	Interventional Radiologist (IR) satisfaction	Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)	end of the procedure
Secondary	Clinical efficacy	Total number of embolization clinical efficacy	up to 6 months
Secondary	Other liquid embolics	Total number of procedures with a need to complete with another liquid embolic to achieve optimal result	end of the procedure
Secondary	Quality of life	Patient's quality of life (EQ-5D)	up to 6 months
Secondary	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	6 months