Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.

Phase 4

• Conditions: Angiosarcoma; Arteriovenous Malformation; Hemangioendothelioma; Congenital Hemangioma
• Interventions: Drug: Lipiodol® Ultra Fluid with surgical glues

• Registration Number: NCT02625389
• Lead Sponsor: Guerbet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-09
• Study Start: 2017-11-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19
• Primary Completion: 2020-09
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embolization with Lipiodol Ultra Fluid and glue	Lipiodol® Ultra Fluid with surgical glues	-

Primary Outcome Measures

Name	Time	Method
Adverse drug reactions during any session of embolization	at the time patient leaving the catheterization room (Day 0)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital; 🇮🇳 Gurgaon, Haryana, India

Christian Medical College Hospital; 🇮🇳 Vellore, Tamil Nadu, India