Safety and Efficacy of Lipiodol® Ultra Fluid in Association with Surgical Glues during Vascular Embolization

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional, transversal with longitudinal follow-up, multicenter

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  IODINATED (I 131) ETHYL ESTERS OF THE FATTY ACIDS OF POPPY-SEED OIL

  ENBUCRILATE

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  110

Study design details

• Main study objective:
  To evaluate the per-procedure safety of Lipiodol® Ultra Fluid in association with surgical glues during vascular embolization of non-hemorrhagic lesions in routine medical practice.
• Outcomes:
  Adverse Drugs Reactions, Adverse Events
• Data analysis plan:
  Descriptive statistical methods will be used to report all safety and efficacy assessments in this non-interventional study.For assessment of the primary criterion and secondary criteria related to safety, occurrence of ADRs and AEs will be tabulated in terms of number and percentage as well as their associated characteristics such as intensity, actions taken, outcome, and causal relationship to the study drug. Prevalence of ADRs occurring during the first vascular embolization session will be calculated for the primary criterion.