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

Study identification

• EU PAS number:
  EUPAS8702
• Study ID:
  8703
• Official title and acronym:
  Safety and Efficacy of Lipiodol® Ultra Fluid in Association with Surgical Glues during Vascular Embolization
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  Non-interventional, transversal with longitudinal follow-up, multicenter, Phase IV (India) study.The study is designed to investigate the safety of Lipiodol® Ultra Fluid in association with surgical glues used in routine medical practice of vascular embolization. In an observational approach, subjects will be enrolled prospectively with the main condition that they are scheduled for at least one session of vascular embolization using Lipiodol® Ultra Fluid in association with surgical glues. Participation to the study will not alter the normal care of the subject. The transversal (i.e. per-procedure) safety evaluation will be enabled by appropriate records of safety events during the time frame of the first session of vascular embolization using Lipiodol® Ultra Fluid in association with surgical. Safety evaluation will be completed with longitudinal records of safety up to 7 days after the first embolization session and with a further per-procedure evaluation including additional sessions of vascular embolization using Lipiodol® Ultra Fluid in association with surgical glues if any during the 7-days follow-up. Efficacy evaluation will rely on the level of lesion(s) obliteration after embolization compared to the pre-procedural target level of obliteration. Exploratory descriptive statistical methods will be used to evaluate safety and efficacy, using both the total population and subsets of patients with similar clinical conditions.
• Study status:
  Planned

Research institutions and networks

Institutions

Dr Suyash Kulkarni,MD

Study timelines

Date when funding contract was signed

Planned: 31/03/2015

Study start date

Planned: 15/04/2015

Date of final study report

Planned: 30/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Guerbet

Regulatory

• Was the study required by a regulatory body?:
  Yes