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CompletedNCT02269995Updated Nov 5, 2018

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

An observational study in Hepatocellular Carcinoma, sponsored by Eisai Co., Ltd.. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2018-11-05.

Sponsored by Eisai Co., Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Sex
All
01

Study 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
02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular
  • Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 300 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Hepatocellular carcinoma

Inclusion criteria

Patients with Hepatocellular carcinoma

Exclusion criteria

Exclusion criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • E7040

    Device: E7040

Interventions

  • DeviceE7040

    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 .

    Also known as: DC Beads

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability as measured by Adverse Events

    Time frame: Up to 30 days

Secondary outcomes

  1. Efficacy of DC bead as assessed by embolic performance

    Time frame: Up to 30 days

07

Study locations

1 site
  • Multiple Locations, Japan
08

References and documents

Publications

  • Jpn J Intervent Radiol. 2017;32:136-141.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02269995
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Oct 21, 2014
Start date
Mar 6, 2014
Primary completion
May 14, 2015
Completion
Dec 25, 2015
Last update
Nov 5, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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