Safety and Efficacy of LipiodolÂ® Ultra Fluid in Association with Surgical Glues during Vascular Embolization (In-LiVE study). - In-LiVE study

GUERBET0 个研究点目标入组 110 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Female or male adult subject.
•2.Subject scheduled for endovascular embolization of single or multiple lesion(s), using
•selective transarterial catheterization and LipiodolÂ® Ultra Fluid in association with surgical glues as only embolization material, in the next stage of the therapeutic or palliative strategy.
•3. Subject not previously treated for this/those lesion(s) by endovascular embolization using
•LipiodolÂ® Ultra Fluid in association with surgical glues
•4. Subject able and willing to participate to the study.
•5.Subject having read the information, having consented to audio-visual recording of informed
•consent process and having provided his/her consent to participate in writing by dating and
•signing the informed consent form or subject unable to consent in writing whose free and
•voluntary consent is confirmed in writing by a legal representative or impartial witness, prior
•to any study related procedure being conducted.

•1. Subject scheduled for endovascular embolization using embolization materials and radiopaque material other than LipiodolÂ® Ultra Fluid in association with surgical glues, whether in combination or alone, during the study catheterization procedure.
•2. Subject with known contra-indications to vascular embolization (e.g. presence of portal thrombosis.
•3.Subject for whom lesion(s) to be embolized is/are acutely bleeding.
•4. Subject presenting life-threatening emergency situation.
•5. Subject with known contra-indication(s) to the use or with known sensitivity to LipiodolÂ® Ultra Fluid, to its ingredients or to drugs from a similar pharmaceutical class.
•6. Subject currently treated with beta-blockers, metformin or subject who stopped beta-blockers, metformin less that 2 days prior to vascular embolization as described in LipiodolÂ® Ultra Fluid Summary of Product Characteristics.
•7. Subject previously treated with Interleukin II as described in LipiodolÂ® Ultra Fluid Summary of Product Characteristics.
•8.Subject currently treated with effective anticoagulant therapy.
•9. Pregnant or breast-feeding female subject.

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