Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.
Status:
Recruiting
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
This study is multicenter (up to 10 sites in India) phase IV Post-Marketing Study. The study
is designed to investigate the safety of Lipiodol® Ultra Fluid in association with surgical
glues used according to each site medical practice of vascular embolization. Subjects will be
enrolled with the main condition that a procedure of vascular embolization using Lipiodol®
Ultra Fluid in association with surgical glues is part of their therapeutic/palliative
strategy for their disease. The vascular embolization using Lipiodol® Ultra Fluid in
association with surgical glue will be administered as study procedure. According to the
patient need and health status a second vascular embolization using Lipiodol® Ultra Fluid in
association with surgical glue may be considered by the investigator within the next 30 days
after the first one. In this case, this procedure will be considered as a second study
procedure. The per-procedure safety evaluation will be enabled by appropriate records of
safety events during the time frame of the procedure of vascular embolization using Lipiodol®
Ultra Fluid in association with surgical glues. Safety evaluation will be completed with
safety records within 30 +/-3 days after the embolization procedure. 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 subjects with
similar clinical conditions.