To find out side effects and effectiveness of Lipiodol Ultra Fluid along with surgical glues used in blocking one or more abnormal connections of blood vessels.
- Conditions
- Health Condition 1: null- Patients presenting lesions scheduled for vascular embolization with Lipiodol® Ultra Fluid in Association with Surgical Glues
- Registration Number
- CTRI/2015/11/006389
- Lead Sponsor
- GUERBET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 110
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method