Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02300532
Collaborator
(none)
561
2
26.4
280.5
10.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
561 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Actual Study Start Date
:
Jan 10, 2013
Actual Primary Completion Date
:
Jul 10, 2014
Actual Study Completion Date
:
Mar 24, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg |
Other: No intervention
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events/Serious Adverse Events [Up to 3 months]
Secondary Outcome Measures
- Survival rate [Up to 1 year]
Survival rate of subjects measured up to 1 year after implantation of Gliadel
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
- All-patient of Gliadel implantation
Exclusion criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Osaka | Japan | |||
| 2 | Tokyo | Japan |
Sponsors and Collaborators
- Eisai Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eisai Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02300532
Other Study ID Numbers:
- GLI01S
First Posted:
Nov 25, 2014
Last Update Posted:
Feb 27, 2017
Last Verified:
Jan 1, 2017
Keywords provided by Eisai Co., Ltd.
Additional relevant MeSH terms: