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

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269995
• Other study ID #: DCB01S
• Status: Completed
• Start date: March 6, 2014
• Est. completion date: December 25, 2015

Study information

• Verified date: January 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 25, 2015
• Est. primary completion date: May 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

Patients with Hepatocellular carcinoma

Exclusion criteria:

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• E7040
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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Jpn J Intervent Radiol. 2017;32:136-141.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability as measured by Adverse Events		Up to 30 days
Secondary	Efficacy of DC bead as assessed by embolic performance		Up to 30 days