CompletedNCT02625389Updated Oct 10, 2025Results posted

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

A Phase 4 interventional study of Lipiodol Ultra Fluid with surgical glues in Congenital Hemangioma, Hemangioendothelioma and Angiosarcoma, sponsored by Guerbet. Completed at 16 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.

Sponsored by Guerbet · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 132
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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 studied

Congenital Hemangioma
Hemangioendothelioma
Angiosarcoma
Arteriovenous Malformations

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In context

Hemangioendothelioma

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Lead sponsor

Guerbet is the lead sponsor of 42 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Female or male adult subject older than 18 years,
Subject presenting with vascular lesions/anomalies whether malformative (arterial, venous, arteriovenous, fistula) or tumoral (benign: hemoangioma; malignant, angiosarcoma) eligible for vascular embolization of single or multiple lesion(s), using selective transarterial catheterization and Lipiodol® Ultra Fluid in association with surgical glues as only embolization material, in the next stage of the therapeutic or palliative strategy,
Subject not previously treated for this/those lesion(s) by vascular embolization using Lipiodol® Ultra Fluid in association with surgical glues,
Subject able and willing to participate to the study,
Subject having read the information, having consented to audio-visual recording of process and having provided his/her consent to participate in writing by dating and signing the informed consent form or subject unable to consent in writing whose free and voluntary consent is confirmed in writing by a legal representative or impartial witness, prior to any study related procedure being conducted.

Non inclusion criteria :

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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 132 participants (actual)

Study arms

Experimental
Vascular embolization with Lipiodol Ultra Fluid and surgical glue
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

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

What researchers measure

Primary outcomes

Adverse Drug Reactions During the Embolization Procedure
Time frame: Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)

Secondary outcomes

Adverse Drug Reactions up to One Month After the Embolization Procedure
Time frame: Collected between laboratory discharge and up to one month post-procedure
Adverse Events up to One Month After the Embolization Procedure
Time frame: Collected up to one month post-procedure
Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score
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%
Time frame: Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure)

Results

Posted Oct 10, 2025

Participant flow

Participant flow — Overall Study
Milestone	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Started	124
Completed	124
Not completed	0

Outcome measures

PrimaryAdverse Drug Reactions During the Embolization Procedure

Time frame:: Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)
Reported as:: Count of participants · Participants

Adverse Drug Reactions During the Embolization Procedure
Participants	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Adverse Drug Reactions During the Embolization Procedure	0

SecondaryAdverse Drug Reactions up to One Month After the Embolization Procedure

Time frame:: Collected between laboratory discharge and up to one month post-procedure
Reported as:: Count of participants · Participants

Adverse Drug Reactions up to One Month After the Embolization Procedure
Participants	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Adverse Drug Reactions up to One Month After the Embolization Procedure	1

SecondaryAdverse Events up to One Month After the Embolization Procedure

Time frame:: Collected up to one month post-procedure
Reported as:: Count of participants · Participants

Adverse Events up to One Month After the Embolization Procedure
Participants	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Adverse Events up to One Month After the Embolization Procedure	23

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

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%

Time frame:: Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure)
Reported as:: Count of units · Lesions

Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score
Lesions	First Embolization Procedure	Second Embolization Procedure
Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score	119	11

Adverse events

Collected over Adverse events were collected from informed consent signature up to one month after the last embolisation procedure (from 33 days up to 66 days after first embolisation procedure). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue	0/124 (0%)	2/124 (1.6%)	23/124 (18.5%)

Most frequent serious events

Most frequent serious events
Event	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
HydrocephalusNervous system disorders	1/124
Cerebellar infarctionNervous system disorders	1/124
Peripheral ischaemiaVascular disorders	1/124

Most frequent other events

Showing 10 of 30

Most frequent other events
Event	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Post embolisation syndromeInjury, poisoning and procedural complications	6/124
Injection site painGeneral disorders	3/124
PyrexiaGeneral disorders	2/124
Skin necrosisSkin and subcutaneous tissue disorders	2/124
AstheniaGeneral disorders	1/124
Catheter site painGeneral disorders	1/124
Catheter site related reactionGeneral disorders	1/124
Catheter site swellingGeneral disorders	1/124
Injection site swellingGeneral disorders	1/124
Abdominal pain lowerInjury, poisoning and procedural complications	1/124

Baseline characteristics

All patients who received the Lipiodol and surgical glue mixture

Age, Continuous
Age, Continuous(years)	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Mean	34.2 ± 13.6

Sex: Female, Male
Sex: Female, Male(Participants)	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Female	69
Male	55

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue

Region of Enrollment
Region of Enrollment(Participants)	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
India	124

Body Mass Index
Body Mass Index(kg/m^2)	Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Mean	21.93 ± 3.49

Study locations

16 sites

Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital
Gurgaon, Haryana 122001, India
Mahatma Gandhi Missions Medical college and Hospital
Aurangabad, 431003, India
KLES Dr. Prabhakar Kore Hospital
Belagavi, 590010, India
Victoria Hospital
Bengaluru, 560002, India
Mazumdar Shaw medical Centre
Bengaluru, 560099, India
Apollo Hospital
Hyderabad, 500096, India
AIIMS
Jodhpur, 342005, India
Sanjay Gandhi Post Graduate Institute of Meducal Sciences (SGPGI)
Lucknow, 226014, India
Government Medical College
Nagpur, 440009, India
BLK Super Speciality Hospital
New Delhi, 110005, India
AIIMS
New Delhi, 110029, India
B.J Govt College & Sassoon Hospitals
Pune, 411001, India
KEM Hospital
Pune, 411011, India
7 Orange Hospitals
Pune, 411033, India
Geetanjali Medical College and Hospital
Udaipur, 313002, India
Acharya Vinobha Bhave Hospital
Wardha, 442004, India

References and documents

Study documents

Study protocol ↗ · Jan 20, 2017
Statistical analysis plan ↗ · Jun 30, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02625389
Lead sponsor: Guerbet
Responsible party: Sponsor
First posted: Dec 9, 2015
Start date: Nov 29, 2017
Primary completion: May 12, 2021
Completion: May 12, 2021
Results posted: Oct 10, 2025
Last update: Oct 10, 2025

Study contacts

Jing Hao, MD

study director · Guerbet

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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