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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02300532
Enrollment
561
Registered
2014-11-25
Start date
2013-01-10
Completion date
2015-03-24
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Glioma

Keywords

Malignant Glioma, Glioblastoma Multiforme

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.

Interventions

OTHERNo intervention

Sponsors

Eisai Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All-patient of Gliadel implantation

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Number of Adverse Events/Serious Adverse EventsUp to 3 months

Secondary

MeasureTime frameDescription
Survival rateUp to 1 yearSurvival rate of subjects measured up to 1 year after implantation of Gliadel

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026