A Study to Evaluate How Safe and Effective is the Mixture of Lipiodol® Ultra Fluid and Glue When Used for Embolization Procedures

NCT02625389 | Completed Phase 4 Results

• 3 other identifiers: LUF-44-001CTRI/2017/05/008607EUPAS15045
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Congenital Hemangioma; Hemangioendothelioma; Angiosarcoma; Arteriovenous Malformations

Outcome Measures

Primary Outcomes (1)

• Adverse Drug Reactions During the Embolization Procedure

  Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)

Secondary Outcomes (3)

• Adverse Drug Reactions up to One Month After the Embolization Procedure

  Collected between laboratory discharge and up to one month post-procedure

• Adverse Events up to One Month After the Embolization Procedure

  Collected up to one month post-procedure

• Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score

  Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure)

Study Arms (1)

Vascular embolization with Lipiodol Ultra Fluid and surgical glue

EXPERIMENTAL

Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) was used in association with surgical glues. The glue was chosen according to the investigator and site practice and knowledge. The mixture ratio (Lipiodol Ultra Fluid/Glue) could vary from 20%/80% to 80%/20%. The volume of Lipiodol Ultra Fluid administered during the embolization procedure depended on lesion size but it should not exceed 15 mL.

Drug: Lipiodol Ultra Fluid with surgical glues

Interventions

Lipiodol Ultra Fluid with surgical glues DRUG

Lipiodol Ultra Fluid and surgical glue mixture administered via selective arterial catheterization.

Vascular embolization with Lipiodol Ultra Fluid and surgical glue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject scheduled for vascular embolization using embolization materials and radiopaque material other than Lipiodol® Ultra Fluid in association with surgical glues (e.g. embolizing fluids such as alcohol or sclerosant agents; particles; implants such as coils or microcoils or balloons; powdered metals such as tantalum or tungsten), whether in combination or alone,
• Subject with known contra-indications to vascular embolization (e.g. severe coagulation disorder, infectious syndrome),
• Subject for whom lesion(s) to be embolized is/are acutely bleeding,
• Subject presenting life-threatening emergency situation,
• Subject with known contra-indication(s) to the use or with known sensitivity to Lipiodol® Ultra Fluid, to its ingredients or to drugs from a similar pharmaceutical class,
• Subject currently treated with beta-blockers, metformin or subject who stopped beta-blockers, metformin less than 2 days prior to vascular embolization as described in Lipiodol® Ultra Fluid SmPC,
• Subject previously treated with Interleukin II as described in Lipiodol® Ultra Fluid SmPC,
• Subject currently treated with effective anticoagulant therapy.
• Pregnant or breast-feeding female subject,
• Subject having received any IMP within 7 days prior to enrolment,
• Subject with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the subject's safety or her/his ability to participate to the study,
• Subject unlikely to comply with the protocol, e.g. uncooperative attitude, and unlikely to complete the study,
• Subject related to the Investigator or any other study staff or relative directly involved in the study conduct.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (16)

Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital

Gurgaon, Haryana, 122001, India

Location

Mahatma Gandhi Missions Medical college and Hospital

Aurangabad, 431003, India

Location

KLES Dr. Prabhakar Kore Hospital

Belagavi, 590010, India

Location

Victoria Hospital

Bengaluru, 560002, India

Location

Mazumdar Shaw medical Centre

Bengaluru, 560099, India

Location

Apollo Hospital

Hyderabad, 500096, India

Location

AIIMS

Jodhpur, 342005, India

Location

Sanjay Gandhi Post Graduate Institute of Meducal Sciences (SGPGI)

Lucknow, 226014, India

Location

Government Medical College

Nagpur, 440009, India

Location

BLK Super Speciality Hospital

New Delhi, 110005, India

Location

AIIMS

New Delhi, 110029, India

Location

B.J Govt College & Sassoon Hospitals

Pune, 411001, India

Location

KEM Hospital

Pune, 411011, India

Location

7 Orange Hospitals

Pune, 411033, India

Location

Geetanjali Medical College and Hospital

Udaipur, 313002, India

Location

Acharya Vinobha Bhave Hospital

Wardha, 442004, India

Location

MeSH Terms

Conditions

Hemangioendothelioma; Hemangiosarcoma; Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Connective and Soft Tissue; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Jing Hao, MD, Global Head of Medical Affairs & Clinical Development
• Organization: Guerbet

jing.hao@guerbet.com

+33 (0) 1 45 91 50 00

Study Officials

• Jing Hao, MD

  Guerbet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 9, 2015
• Study Start: November 29, 2017
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: October 10, 2025
• Results First Posted: October 10, 2025

Record last verified: 2025-09

Locations

IN (16)