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

Malignant Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300532
• Other study ID #: GLI01S
• Status: Completed
• Phase: N/A
• First received: November 21, 2014
• Last updated: February 23, 2017
• Start date: January 10, 2013
• Est. completion date: March 24, 2015

Study information

• Verified date: January 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: March 24, 2015
• Est. primary completion date: July 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• All-patient of Gliadel implantation

Exclusion criteria:

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events/Serious Adverse Events		Up to 3 months
Secondary	Survival rate	Survival rate of subjects measured up to 1 year after implantation of Gliadel	Up to 1 year