CTRI/2017/05/008607已完成4 期
Safety and Efficacy of Lipiodol® Ultra Fluid in Association with Surgical Glues during Vascular Embolization, a Phase IV study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- GUERBET
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Female or male adult subject older than 18 years
- •2. Subject presenting with vascular lesions/anomalies whether malformative (arterial, venous, arteriovenous, fistula) or tumoral (benign: hemangioma; malignant, angiosarcoma) eligible for vascular embolization of single or multiple lesion(s), using selective transarterial catheterization and Lipiodol® 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 vascular embolization using Lipiodol® 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
排除标准
- •1.Subject scheduled for vascular embolization using embolization materials and radiopaque material other than Lipiodol® Ultra Fluid in association with surgical glues (e.g. embolizing fluids such as alcohol or sclerosant agents; particles; implants such as coils or microcoils or balloons; powdered metals such as tantalum or tungsten), whether in combination or alone.
- •2. Subject with known contra-indications to vascular embolization (e.g. severe coagulation disorder, infectious syndrome, presence of portal thrombosis)
- •3. Subject whose lesion(s) to be embolized is/are acutely bleeding
- •4. Subject presenting with life-threatening emergency situation
- •5. Subject with known contra-indication(s) to the use or with known sensitivity to Lipiodol® 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 Lipiodol® Ultra Fluid Summary of Product Characteristics
- •7. Subject previously treated with Interleukin II as described in Lipiodol® Ultra Fluid Summary of Product Characteristics
- •8. Subject currently treated with effective anticoagulant therapy
- •9. Pregnant or breast-feeding female subject
- •10. Subject having received any investigational medicinal product within 7 days prior to enrolment
- •11. Subject with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the subjectâ??s safety or her/his ability to participate to the study.
- •12.Subject unlikely to comply with the protocol, e.g. uncooperative attitude, and unlikely to complete the study.
- •13. Subject related to the Investigator or any other study staff or relative directly involved in the study conduct
研究者
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