Congenital HemangiomaPhase 4NCT02625389
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 study testing Lipiodol Ultra Fluid with surgical glues in people with Congenital Hemangioma and Hemangioendothelioma, run by Guerbet at 16 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Hemangioma, Hemangioendothelioma, Angiosarcoma
- What is being tested?
- Lipiodol Ultra Fluid with surgical glues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 16 sitesIndia
- Study dates
- 29 Nov 2017to 12 May 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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 informed consent 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 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
India16 sites
Mahatma Gandhi Missions Medical college and Hospital
Aurangabad, 431003
KLES Dr. Prabhakar Kore Hospital
Belagavi, 590010
Victoria Hospital
Bengaluru, 560002
Mazumdar Shaw medical Centre
Bengaluru, 560099
Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital
Gurgaon, Haryana, 122001
Apollo Hospital
Hyderabad, 500096
AIIMS
Jodhpur, 342005
Sanjay Gandhi Post Graduate Institute of Meducal Sciences (SGPGI)
Lucknow, 226014
Government Medical College
Nagpur, 440009
BLK Super Speciality Hospital
New Delhi, 110005
AIIMS
New Delhi, 110029
B.J Govt College & Sassoon Hospitals
Pune, 411001
KEM Hospital
Pune, 411011
7 Orange Hospitals
Pune, 411033
Geetanjali Medical College and Hospital
Udaipur, 313002
Acharya Vinobha Bhave Hospital
Wardha, 442004
About this study
Official title: 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.
- Being tested
- Lipiodol Ultra Fluid with surgical glues
- Medical subject headings
- Hemangioendothelioma, Hemangiosarcoma, Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiodol Ultra Fluid with surgical gluesDrug
Lipiodol Ultra Fluid and surgical glue mixture administered via selective arterial catheterization.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lipiodol Ultra Fluid with surgical glues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Drug Reactions During the Embolization Procedure
Measured: 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
Measured: Collected between laboratory discharge and up to one month post-procedure
Adverse Events up to One Month After the Embolization Procedure
Measured: 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%
Measured: Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start29 Nov 2017
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital HemangiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Hao, MD, Study director, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625389
- Sponsor's protocol ID
- LUF-44-001
- Other IDs
- CTRI/2017/05/008607, EUPAS15045
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2015
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization
- ClinicalTrials.gov ID
- NCT02625389
- Acronym / sponsor ID
- LUF-44-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Posted 10 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular embolization with Lipiodol Ultra Fluid and surgical glue | Experimental | Drug: Lipiodol Ultra Fluid with surgical gluesLipiodol 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipiodol Ultra Fluid with surgical gluesLipiodol Ultra Fluid and surgical glue mixture administered via selective arterial catheterization. | Drug | Vascular embolization with Lipiodol Ultra Fluid and surgical glue |
Primary outcome
Adverse Drug Reactions During the Embolization Procedure
Time frame: Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)
3 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
Time frame: Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Hao, MD study director
Guerbet
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipiodol Ultra Fluid with surgical glues in people with Congenital Hemangioma and Hemangioendothelioma, run by Guerbet at 16 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Drug Reactions During the Embolization Procedure (time frame: Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.