Liver-PILP First-in-Man (PILP FiM)
Recruitment status was: Recruiting
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases|
- To demonstrate the feasibility of the liver PILP intervention. [ Time Frame: During intervention and up to 30 days post intervention ] [ Designated as safety issue: Yes ]The liver PILP intervention will be considered feasible if the intervention is demonstrated to be safe and the PILP kit performs according to specifications related to localization, flow rates and retrieval of devices.
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Liver-PILP kit
Device: Liver-PILP kit
Device: Liver-PILP kit The Liver-PILP kit (three devices) is composed of percutaneous, disposable (single-use), catheter-based devices for targeted, isolated, organ specific (liver), drug delivery and perfusion with high dose drugs.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250158
|University Hospital Louvain Saint-Luc|
|Brussels, Belgium, 1200|
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|University Hospitals Leuven, Catholic University|
|Leuven, Belgium, 3000|
|Principal Investigator:||Eric Van Cutsem, Prof MD PhD||University Hospitals Leuven, Catholic University|
|Principal Investigator:||Karen Geboes, Prof MD Phd||University Hospital, Ghent|
|Principal Investigator:||Luc Defreyne, Prof MD PhD||University Hospital, Ghent|
|Principal Investigator:||Marc Van den Eynde, MD||University Hospital Louvain Saint-Luc|