Post-Marketing Surveillance of Gliadel 7.7mg Implant (All... | NCT02300532

Studies
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)

NCT02300532

Sponsor

Eisai Co., Ltd.

Status

Completed

Last Update Posted

Feb 27, 2017Actual

Enrollment

561Actual

Phase

Not provided

Conditions

Malignant Glioma

Interventions

No intervention

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

Jan 10, 2013Actual

Primary Completion Date

Jul 10, 2014Actual

Completion Date

Mar 24, 2015Actual

First Submitted Date

Nov 21, 2014

First Submission Date that Met QC Criteria

Nov 24, 2014

First Posted Date

Nov 25, 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

Feb 23, 2017

Last Update Posted Date

Feb 27, 2017Actual

Description Module

Brief Summary

Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.

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

561Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Adverse Events/Serious Adverse Events		Up to 3 months

Secondary Outcomes

Measure	Description	Time Frame
Survival rate	Survival rate of subjects measured up to 1 year after implantation of Gliadel	Up to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

All-patient of Gliadel implantation

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 diagnosed malignant glioma treated by surgery

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma
D005909	Glioblastoma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Osaka	Osaka		Japan