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

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: E7040

• Registration Number: NCT02269995
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-06
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-21
• Primary Completion: 2015-05-14
• Study Completion: 2015-12-25
• Status Verified: 2017-01
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
E7040	E7040	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as measured by Adverse Events	Up to 30 days

Secondary Outcome Measures

Name	Time	Method
Efficacy of DC bead as assessed by embolic performance	Up to 30 days