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

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.

Completed

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Key information

Conditions

Malignant Glioma Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All-patient of Gliadel implantation

Exclusion criteria

None

Treatment and study plan

No intervention

Other

Primary outcomes

Number of Adverse Events/Serious Adverse Events

Time frame: Up to 3 months

Secondary outcomes

Survival rate

Time frame: Up to 1 year

Survival rate of subjects measured up to 1 year after implantation of Gliadel

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Nov 25, 2014
Registry last updated: Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed