Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization. (In-Live)
Primary Purpose
Congenital Hemangioma, Hemangioendothelioma, Angiosarcoma
Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Lipiodol® Ultra Fluid with surgical glues
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Hemangioma focused on measuring scheduled for selective transarterial catheterization
Eligibility Criteria
- Female or male adult subject older than 18 years
- Subject presenting with vascular lesions/anomalies whether malformative or tumoral eligible for endovascular 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 endovascular 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, during the study catheterization procedure
- Subject with known contra-indications to vascular embolization (e.g. presence of portal thrombosis)
- 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 that 2 days prior to vascular embolization as described in Lipiodol® Ultra Fluid Summary of Product Characteristics
- Subject previously treated with Interleukin II as described in Lipiodol® Ultra Fluid Summary of Product Characteristics
- Subject currently treated with effective anticoagulant therapy
- Pregnant or breast-feeding female subject
- Subject having received any investigational medicinal product 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
Sites / Locations
- Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity HospitalRecruiting
- Christian Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Embolization with Lipiodol Ultra Fluid and glue
Arm Description
Outcomes
Primary Outcome Measures
Adverse drug reactions during any session of embolization
Secondary Outcome Measures
Adverse drug reactions up to one month follow-up
Adverse events up to one month follow-up
Obliteration rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02625389
Brief Title
Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.
Acronym
In-Live
Official Title
Safety and Efficacy of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization. A Phase IV Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is multicenter (up to 10 sites in India) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Hemangioma, Hemangioendothelioma, Angiosarcoma, Arteriovenous Malformation
Keywords
scheduled for selective transarterial catheterization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Embolization with Lipiodol Ultra Fluid and glue
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lipiodol® Ultra Fluid with surgical glues
Intervention Description
Lipiodol® Ultra Fluid and surgical glue mixture may vary from 20 to 80% and should be administered via selective arterial catheterization only.
Primary Outcome Measure Information:
Title
Adverse drug reactions during any session of embolization
Time Frame
at the time patient leaving the catheterization room (Day 0)
Secondary Outcome Measure Information:
Title
Adverse drug reactions up to one month follow-up
Time Frame
Collected at follow-up up to one month follow-up
Title
Adverse events up to one month follow-up
Time Frame
Collected at follow-up up to one month follow-up
Title
Obliteration rate
Time Frame
at angiogram after the first session of embolization (Day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Female or male adult subject older than 18 years
Subject presenting with vascular lesions/anomalies whether malformative or tumoral eligible for endovascular 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 endovascular 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, during the study catheterization procedure
Subject with known contra-indications to vascular embolization (e.g. presence of portal thrombosis)
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 that 2 days prior to vascular embolization as described in Lipiodol® Ultra Fluid Summary of Product Characteristics
Subject previously treated with Interleukin II as described in Lipiodol® Ultra Fluid Summary of Product Characteristics
Subject currently treated with effective anticoagulant therapy
Pregnant or breast-feeding female subject
Subject having received any investigational medicinal product 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corinne Dubourdieu
Phone
+33 1 45 91 50 00
Email
corinne.dubourdieu@guerbet-group.com
First Name & Middle Initial & Last Name or Official Title & Degree
Camille Pitrou
Phone
+33 1 45 91 50 00
Email
camille.pitrou@guerbet-group.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre DESCHE, MD
Organizational Affiliation
Guerbet
Official's Role
Study Chair
Facility Information:
Facility Name
Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
Christian Medical College Hospital
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632002
Country
India
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.
We'll reach out to this number within 24 hrs