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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
| Cromsource | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver-PILP kit | Experimental | Liver-PILP kit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver-PILP kit | Device | 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the feasibility of the liver PILP intervention. | 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. | During intervention and up to 30 days post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Van Cutsem, Prof MD PhD | Contact | +32 16 344218 | Eric.VanCutsem@uz.kuleuven.ac.be |
| Name | Affiliation | Role |
|---|---|---|
| Eric Van Cutsem, Prof MD PhD | University Hospitals Leuven, Catholic University | Principal Investigator |
| Karen Geboes, Prof MD Phd | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Louvain Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20495978 | Background | Maleux G, Monbaliu D, Verslype C, Casteleyn C, Van De Velde M, Cornillie P, Hoogeveen Y, Van Cutsem E. Percutaneous isolated liver perfusion with occlusion balloons and a catheter-based stent-graft-like perfusion device: an experimental study in a porcine model. Eur Radiol. 2010 Oct;20(10):2372-80. doi: 10.1007/s00330-010-1816-5. Epub 2010 May 22. |
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|
| Luc Defreyne, Prof MD PhD |
| University Hospital, Ghent |
| Principal Investigator |
| Marc Van den Eynde, MD | University Hospital Louvain Saint-Luc | Principal Investigator |
| University Hospital Ghent | Recruiting | Ghent | 9000 | Belgium |
|
| University Hospitals Leuven, Catholic University | Recruiting | Leuven | 3000 | Belgium |
|