Lipiodol Ultra Fluid with surgical glues
DrugLipiodol Ultra Fluid and surgical glue mixture administered via selective arterial catheterization.
NCT Number: NCT02625389
This was a multicenter 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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital, Gurgaon, Haryana, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Non inclusion criteria :
Lipiodol Ultra Fluid and surgical glue mixture administered via selective arterial catheterization.
Time frame: Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)
Time frame: Collected between laboratory discharge and up to one month post-procedure
Time frame: Collected up to one month post-procedure
Time frame: Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure)
Level of obliteration of the vascular bed of a lesion is evaluated in percentage (%) and distributed in a 4-level score : (1) <50%, (2) 50-75%, (3) 75-99%, and (4) 100%
Guerbet
Industry
Safety and Efficacy of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization
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