Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2017/05/008607 | Registry Identifier | CTRI | |
| EUPAS15045 | Registry Identifier | EU PAS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipiodol Ultra Fluid with surgical glues | Drug | Lipiodol Ultra Fluid and surgical glue mixture administered via selective arterial catheterization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Drug Reactions During the Embolization Procedure | Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Non inclusion criteria :
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jing Hao, MD | Guerbet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital | Gurgaon | Haryana | 122001 | India | ||
Among the 132 included subjects, 124 received the Lipiodol Ultra Fluid and surgical glue mixture and were analyzed for safety and efficacy
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2017 | Jun 3, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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% | Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure) |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
All patients who received the Lipiodol and surgical glue mixture
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Drug Reactions During the Embolization Procedure | Posted | Count of Participants | Participants | Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Adverse Drug Reactions up to One Month After the Embolization Procedure | Posted | Count of Participants | Participants | Collected between laboratory discharge and up to one month post-procedure |
|
| |||||||||||||||||||||||||||||
| Secondary | Adverse Events up to One Month After the Embolization Procedure | Posted | Count of Participants | Participants | Collected up to one month post-procedure |
|
| |||||||||||||||||||||||||||||
| Secondary | 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% | The total number of lesions treated was 138, but the actual obliteration rate was not reported for 3 lesions. | Posted | Count of Units | Lesions | Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure) | Lesions | Lesions |
|
|
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)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 124 | 2 | 124 | 23 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydrocephalus | Nervous system disorders | MedDRA 24.0 | Systematic Assessment | Not related to the mixture and related to the procedure |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment | Not related to the mixture and related to the procedure |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 24.0 | Systematic Assessment | Not related to the mixture and related to the procedure |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Post embolisation syndrome | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain lower | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Portal hypertensive gastropathy | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment | Related to the mixture |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment | Related to the mixture |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mastication disorder | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jing Hao, MD, Global Head of Medical Affairs & Clinical Development | Guerbet | +33 (0) 1 45 91 50 00 | jing.hao@guerbet.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2021 | Jun 3, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006390 | Hemangioendothelioma |
| D006394 | Hemangiosarcoma |
| D001165 | Arteriovenous Malformations |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| Title | Denominators | Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Lesions |
|
|