Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Congenital Hemangioma Hemangioendothelioma Angiosarcoma Arteriovenous Malformation	Drug: Lipiodol® Ultra Fluid with surgical glues	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization. A Phase IV Study.

Resource links provided by NLM:

Drug Information available for: Ethiodized oil

Genetic and Rare Diseases Information Center resources: Hemangioendothelioma Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:

Adverse drug reactions during any session of embolization [ Time Frame: at the time patient leaving the catheterization room (Day 0) ]

Secondary Outcome Measures:

Adverse drug reactions up to one month follow-up [ Time Frame: Collected at follow-up up to one month follow-up ]
Adverse events up to one month follow-up [ Time Frame: Collected at follow-up up to one month follow-up ]
Obliteration rate [ Time Frame: at angiogram after the first session of embolization (Day 0) ]


Estimated Enrollment:	125
Anticipated Study Start Date:	March 2017
Estimated Study Completion Date:	June 2018
Estimated Primary Completion Date:	June 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Embolization with Lipiodol Ultra Fluid and glue	Drug: Lipiodol® Ultra Fluid with surgical glues Lipiodol® Ultra Fluid and surgical glue mixture may vary from 20 to 80% and should be administered via selective arterial catheterization only.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02625389

Contacts


Contact: Corinne Dubourdieu		corinne.dubourdieu@guerbet-group.com
Contact: Camille Pitrou		camille.pitrou@guerbet-group.com

Locations


India
Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital
Gurgaon, Haryana, India, 122001
Christian Medical College Hospital	Not yet recruiting
Vellore, Tamil Nadu, India, 632002

Sponsors and Collaborators

Guerbet

Investigators


Study Chair:	Pierre DESCHE, MD	Guerbet

More Information


Responsible Party:	Guerbet
ClinicalTrials.gov Identifier:	NCT02625389 History of Changes
Other Study ID Numbers:	LUF-44-001 CTRI/2015/11/006389 ( Registry Identifier: CTRI ) EUPAS15045 ( Registry Identifier: EU PAS )
Study First Received:	December 3, 2015
Last Updated:	March 2, 2017


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Guerbet:


scheduled for selective transarterial catheterization

Additional relevant MeSH terms:


Hemangioendothelioma Congenital Abnormalities Hemangioma Arteriovenous Malformations Hemangiosarcoma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms	Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases Sarcoma Neoplasms, Connective and Soft Tissue Ethiodized Oil Antineoplastic Agents

ClinicalTrials.gov processed this record on July 14, 2017

Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization. (In-Live)