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Safety and Efficacy of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital
Gurgaon, Haryana, India
Mahatma Gandhi Missions Medical college and Hospital
Aurangabad, India
KLES Dr. Prabhakar Kore Hospital
Belagavi, India
Victoria Hospital
Bengaluru, India
Mazumdar Shaw medical Centre
Bengaluru, India
Apollo Hospital
Hyderabad, India
AIIMS
Jodhpur, India
Sanjay Gandhi Post Graduate Institute of Meducal Sciences (SGPGI)
Lucknow, India
Government Medical College
Nagpur, India
BLK Super Speciality Hospital
New Delhi, India
Start Date
November 29, 2017
Primary Completion Date
May 12, 2021
Completion Date
May 12, 2021
Last Updated
October 10, 2025
132
ACTUAL participants
Lipiodol Ultra Fluid with surgical glues
DRUG
Lead Sponsor
Guerbet
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06440005