Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma

This surveillance's objectives are:

1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Factors considered to have effect to safety and effectiveness

Completed

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with Hepatocellular carcinoma

Exclusion criteria

None

Treatment and study plan

E7040

Device

E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .

Other names: DC Beads

Primary outcomes

Safety and Tolerability as measured by Adverse Events

Time frame: Up to 30 days

Secondary outcomes

Efficacy of DC bead as assessed by embolic performance

Time frame: Up to 30 days

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Oct 21, 2014
Registry last updated: Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed