Clinical Trial: Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Safety and Efficacy of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization. A Phase IV Study.

Brief 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.

Detailed Summary:
Sponsor: Guerbet

Current Primary Outcome: Adverse drug reactions during any session of embolization [ Time Frame: at the time patient leaving the catheterization room (Day 0) ]

Original Primary Outcome: Adverse drug reactions during the first session of embolization [ Time Frame: at the time patient leaving the catheterization room (Day 0) ]

Current Secondary Outcome:

  • Adverse drug reactions up to one month follow-up [ Time Frame: Collected at follow-up up to one month follow-up ]
  • Adverse events up to one month follow-up [ Time Frame: Collected at follow-up up to one month follow-up ]
  • Obliteration rate [ Time Frame: at angiogram after the first session of embolization (Day 0) ]


Original Secondary Outcome:

  • Adverse drug reactions up to 7 days follow-up [ Time Frame: Collected at follow-up up to 7 days after embolization ]
  • Adverse events up to 7 days follow-up [ Time Frame: Collected at follow-up up to 7 days after embolization ]
  • percentage of lesion obliteration [ Time Frame: at angiogram after the first session of embolization (Day 0) ]


Information By: Guerbet

Dates:
Date Received: December 3, 2015
Date Started: March 2017
Date Completion: June 2018
Last Updated: March 2, 2017
Last Verified: March 2017