Health Condition 1: null- Patients presenting lesions scheduled for vascular embolization with Lipiodol® Ultra Fluid in Association with Surgical Glues
Conditions
Interventions
Intervention1: Lipiodol® Ultra Fluid (480 mg I/ml), solution for injection: The study is a patient data collection on actual medical procedures with Lipiodol® Ultra Fluid (480 mg I/ml), solution fo
Sponsors
GUERBET
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female or male adult subject. 2.Subject scheduled for endovascular 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 endovascular 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.
Exclusion criteria
Exclusion criteria: 1. Subject scheduled for endovascular embolization using embolization materials and radiopaque material other than Lipiodol® 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Drugs Reactions after administration of Lipiodol® Ultra Fluid in association with surgical glues during the course of the vascular embolization session.Timepoint: Adverse Reactions of Lipiodol® Ultra Fluid in association with surgical glues during the first session (Day-01) of Vascular embolization (until the patient leaves the catheterization room. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ADRs occurring in the whole subject participation period 2. Adverse Events 3. Successful lesions embolizationTimepoint: 1. Adverse drug reactions up to 7 days follow-up after the first vascular embolization session 2. Adverse events up to 7 days follow-up after the first vascular embolization session 3. Successful lesions obliteration at the end of the 1st session of embolization | — |
Countries
India
Contacts
Public ContactKiran Chand
Norwich Clinical Services Pvt. Ltd.
Outcome results
None listed