Trial Outcomes & Findings for A Study to Evaluate How Safe and Effective is the Mixture of Lipiodol® Ultra Fluid and Glue When Used for Embolization Procedures (NCT NCT02625389)
NCT ID: NCT02625389
Last Updated: 2025-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
132 participants
Primary outcome timeframe
Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)
Results posted on
2025-10-10
Participant Flow
Among the 132 included subjects, 124 received the Lipiodol Ultra Fluid and surgical glue mixture and were analyzed for safety and efficacy
Participant milestones
| Measure |
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues.
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|---|---|
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Overall Study
STARTED
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124
|
|
Overall Study
COMPLETED
|
124
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
n=124 Participants
Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues.
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|---|---|
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Age, Continuous
|
34.2 years
STANDARD_DEVIATION 13.6 • n=124 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=124 Participants
|
|
Sex: Female, Male
Male
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55 Participants
n=124 Participants
|
|
Region of Enrollment
India
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124 Participants
n=124 Participants
|
|
Body Mass Index
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21.93 kg/m^2
STANDARD_DEVIATION 3.49 • n=124 Participants
|
PRIMARY outcome
Timeframe: Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)Outcome measures
| Measure |
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
n=124 Participants
Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues.
|
Second Embolization Procedure
Included patients for whom a second embolisation procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues was needed.
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|---|---|---|
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Adverse Drug Reactions During the Embolization Procedure
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0 Participants
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—
|
SECONDARY outcome
Timeframe: Collected between laboratory discharge and up to one month post-procedureOutcome measures
| Measure |
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
n=124 Participants
Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues.
|
Second Embolization Procedure
Included patients for whom a second embolisation procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues was needed.
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|---|---|---|
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Adverse Drug Reactions up to One Month After the Embolization Procedure
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1 Participants
|
—
|
SECONDARY outcome
Timeframe: Collected up to one month post-procedureOutcome measures
| Measure |
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
n=124 Participants
Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues.
|
Second Embolization Procedure
Included patients for whom a second embolisation procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues was needed.
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|---|---|---|
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Adverse Events up to One Month After the Embolization Procedure
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23 Participants
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—
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SECONDARY outcome
Timeframe: Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure)Population: The total number of lesions treated was 138, but the actual obliteration rate was not reported for 3 lesions.
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%
Outcome measures
| Measure |
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
n=135 Lesions
Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues.
|
Second Embolization Procedure
n=13 Lesions
Included patients for whom a second embolisation procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues was needed.
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|---|---|---|
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Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score
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119 Lesions
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11 Lesions
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Adverse Events
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
n=124 participants at risk
Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues.
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|---|---|
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Nervous system disorders
Hydrocephalus
|
0.81%
1/124 • Number of events 1 • 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)
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|
Nervous system disorders
Cerebellar infarction
|
0.81%
1/124 • Number of events 1 • 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)
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|
Vascular disorders
Peripheral ischaemia
|
0.81%
1/124 • Number of events 1 • 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)
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Other adverse events
| Measure |
Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue
n=124 participants at risk
Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues.
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|---|---|
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Nervous system disorders
Seizure
|
0.81%
1/124 • Number of events 1 • 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)
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Skin and subcutaneous tissue disorders
Skin necrosis
|
1.6%
2/124 • Number of events 2 • 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)
|
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Skin and subcutaneous tissue disorders
Blister
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.81%
1/124 • Number of events 1 • 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)
|
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Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
1/124 • Number of events 1 • 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)
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Musculoskeletal and connective tissue disorders
Mastication disorder
|
0.81%
1/124 • Number of events 1 • 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)
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General disorders
Injection site pain
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2.4%
3/124 • Number of events 3 • 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)
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General disorders
Pyrexia
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1.6%
2/124 • Number of events 2 • 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)
|
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General disorders
Asthenia
|
0.81%
1/124 • Number of events 1 • 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)
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General disorders
Catheter site pain
|
0.81%
1/124 • Number of events 1 • 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)
|
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General disorders
Catheter site related reaction
|
0.81%
1/124 • Number of events 1 • 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)
|
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General disorders
Catheter site swelling
|
0.81%
1/124 • Number of events 1 • 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)
|
|
General disorders
Injection site swelling
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Injury, poisoning and procedural complications
Post embolisation syndrome
|
4.8%
6/124 • Number of events 6 • 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)
|
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Injury, poisoning and procedural complications
Abdominal pain lower
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Injury, poisoning and procedural complications
Constipation
|
0.81%
1/124 • Number of events 1 • 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)
|
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Injury, poisoning and procedural complications
Dysphagia
|
0.81%
1/124 • Number of events 1 • 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)
|
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Injury, poisoning and procedural complications
Gastritis
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Injury, poisoning and procedural complications
Portal hypertensive gastropathy
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Nervous system disorders
Burning sensation
|
0.81%
1/124 • Number of events 1 • 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)
|
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Nervous system disorders
Dyskinesia
|
0.81%
1/124 • Number of events 1 • 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)
|
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Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
1/124 • Number of events 1 • 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)
|
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Vascular disorders
Hypertension
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Eye disorders
Eye pruritus
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Eye disorders
Eye swelling
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Ear and labyrinth disorders
Vertigo
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Endocrine disorders
Hypothyroidism
|
0.81%
1/124 • Number of events 1 • 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)
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Infections and infestations
Nasopharyngitis
|
0.81%
1/124 • Number of events 1 • 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)
|
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Investigations
Blood pressure increased
|
0.81%
1/124 • Number of events 1 • 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)
|
|
Psychiatric disorders
Sleep disorder
|
0.81%
1/124 • Number of events 1 • 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)
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Additional Information
Jing Hao, MD, Global Head of Medical Affairs & Clinical Development
Guerbet
Phone: +33 (0) 1 45 91 50 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER