Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT01250158
Status:
UNKNOWN
Last Update Posted:
2013-03-29
First Post:
2010-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liver-PILP First-in-Man
Sponsor:
Medical Device Works NV SA
Organization:
Study Overview
Official Title:
First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
RECRUITING
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:
PILP FiM
Brief Summary:
The purpose of this study is to determine whether the PILP-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.
Detailed Description:
The objective of this Medical Device Study, is to demonstrate the feasibility of the liver PILP intervention.
The liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.
The liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.
Study Oversight
Has Oversight DMC:
True
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?: