Post-marketing Surveillance of DC Bead in Patients With H... | NCT02269995

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

NCT02269995

Sponsor

Eisai Co., Ltd.

Status

Completed

Last Update Posted

Nov 5, 2018Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

E7040

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2014Actual

Primary Completion Date

May 14, 2015Actual

Completion Date

Dec 25, 2015Actual

First Submitted Date

Aug 22, 2014

First Submission Date that Met QC Criteria

Oct 17, 2014

First Posted Date

Oct 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2018

Last Update Posted Date

Nov 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This surveillance's objectives are:

Unknown adverse reactions
Incidences of adverse drug reaction
Factors considered to have effect to safety and effectiveness

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E7040			Device: E7040

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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 .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability as measured by Adverse Events		Up to 30 days

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of DC bead as assessed by embolic performance		Up to 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients with Hepatocellular carcinoma

Exclusion criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Hepatocellular carcinoma

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Jpn J Intervent Radiol. 2017;32:136-141.

ID	Term
D006528	Carcinoma, Hepatocellular
D002277	Carcinoma

ID	Term
D000230	Adenocarcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms