Diseases and Abnormalities at or Before Birth

All Conditions

Neoplasms

Heart and Blood Diseases

Rare Diseases

Congenital Abnormalities

Hemangioendothelioma

Hemangiosarcoma

Hemangioma

Arteriovenous Malformations

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Vascular Malformations

Cardiovascular Abnormalities

Vascular Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Ethiodized Oil

Lipiodol® Ultra Fluid and surgical glue mixture may vary from 20 to 80% and should be administered via selective arterial catheterization only.

Lipiodol® Ultra Fluid with surgical glues

Corinne Dubourdieu

Camille Pitrou

Pierre DESCHE, MD

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.

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

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

Guerbet

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.	NCT02625389	Congenital Hema... Hemangioendothe... Angiosarcoma Arteriovenous M...	Lipiodol® Ultra...	18 Years -	Guerbet
Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.	NCT02625389	Congenital Hema... Hemangioendothe... Angiosarcoma Arteriovenous M...	Lipiodol® Ultra...	18 Years -	Guerbet
Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.	NCT02625389	Congenital Hema... Hemangioendothe... Angiosarcoma Arteriovenous M...	Lipiodol® Ultra...	18 Years -	Guerbet

Spots Global Cancer Trial Database for congenital hemangioma