Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04276090
Status:
TERMINATED
Last Update Posted:
2023-07-25
First Post:
2020-02-16
Brief Title:
Codman CatheterSynchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal MetastasesIntrahepatic Cholangiocarcinoma
Sponsor:
Michael J Cavnar MD
Organization:
University of Kentucky
Study Overview
Official Title:
Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area Using the Codman Vascular Catheter With the Synchromed II Pump for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangiocarcinoma
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
an alternate device became FDA approved
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Due to discontinuation of the Codman C3000 pump an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy This study aims to test the safety of hepatic artery infusion pump placement a standard surgical procedure and intraarterial chemotherapy initiation with the standard medication floxuridine FUDR using the Medtronic Synchromed II pump combined with the Codman arterial catheter in patients with unresectable not removable by surgery liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma This study will determine if complication and pump loss rates will be similar to previously published rates for the Codman system
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None