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

NCT ID: NCT02300532

Last Updated: 2017-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

561 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-10

Study Completion Date

2015-03-24

Brief Summary

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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

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Conditions

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Malignant Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All-patient of Gliadel implantation

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Osaka, Osaka, Japan

Site Status

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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GLI01S

Identifier Type: -

Identifier Source: org_study_id

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