Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198263
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2005-09-12
Brief Title:
Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer
Sponsor:
Inovio Pharmaceuticals
Organization:
Inovio Pharmaceuticals
Study Overview
Official Title:
An Open-Label Study Using the Medpulser Electroporation System to Treat Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the trial is to study the safety and efficacy of the Medpulser Electroporation System with bleomycin in the treatment of head and neck cancer
Detailed Description:
Electroporation therapy is a tumor-specific ablative treatment modality with the potential to manage local tumors without the potentially undesirable side effects of systemic chemotherapy agents or radiotherapy Surgical resection of solid tumors often leaves subjects with significant organ dysfunction andor permanent disfigurement requiring reconstructive surgery In contrast electroporation therapy may offer equivalent disease control to conventional surgery with lessened need for reconstructive surgery Electroporation therapy may also provide economic benefits over conventional surgical and or radiation procedures through reduced operating theatre costs hospital stays and post treatment interventions The ability to shrink or eliminate local tumors with the MedPulser System when used in conjunction with intralesional Bleomycin is an important new possible treatment for the conservative local management of SCCHN and provides a possible alternative treatment option to surgical excision in the management of cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None