Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Completed
- Conditions
- Malignant Glioma
- Interventions
- Other: No intervention
- Registration Number
- NCT02300532
- Lead Sponsor
- Eisai Co., Ltd.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 561
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 No intervention Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg
- Primary Outcome Measures
Name Time Method Number of Adverse Events/Serious Adverse Events Up to 3 months
- Secondary Outcome Measures
Name Time Method Survival rate Up to 1 year Survival rate of subjects measured up to 1 year after implantation of Gliadel