- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02269995
Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma
November 2, 2018 updated by: Eisai Co., Ltd.
This surveillance's objectives are:
- Unknown adverse reactions
- Incidences of adverse drug reaction
- Factors considered to have effect to safety and effectiveness
Study Overview
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multiple Locations, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Hepatocellular carcinoma
Description
Inclusion criteria:
Patients with Hepatocellular carcinoma
Exclusion criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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E7040
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and Tolerability as measured by Adverse Events
Time Frame: Up to 30 days
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of DC bead as assessed by embolic performance
Time Frame: Up to 30 days
|
Up to 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jpn J Intervent Radiol. 2017;32:136-141.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2014
Primary Completion (Actual)
May 14, 2015
Study Completion (Actual)
December 25, 2015
Study Registration Dates
First Submitted
August 22, 2014
First Submitted That Met QC Criteria
October 17, 2014
First Posted (Estimate)
October 21, 2014
Study Record Updates
Last Update Posted (Actual)
November 5, 2018
Last Update Submitted That Met QC Criteria
November 2, 2018
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCB01S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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