Liver-PILP First-in-Man

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases

Conditions
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Liver Metastases

Intervention / Treatment
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* Device: Liver-PILP kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1 Unresectable metastatic disease predominant in the liver Exclusion Criteria: More than 60 % tumor involved liver tissue Abnormal vascular anatomy Severe atherosclerosis Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries Short suprahepatic vena cava segment (< 1.5 cm) One or both jugular veins are occluded Other severe, concomitant diseases regarding the subject status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver-PILP kit<br>Liver-PILP kit | Device: Liver-PILP kit<br>* 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 Portal Vein Device (PVD): balloon catheter to occlude the portal vein and allow aspiration through a central lumen for portal veno-venous bypass. The Hepatic Artery Device (HAD): balloon catheter to occlude arterial flow to the liver. The Vena Cava Device (VCD): catheter based device to isolate and access hepatic outflow to vena cava by creating a closed chamber in vena cava at ostia of the hepatic veins while maintaining central vena cava blood flow from lower extremities to right atrium through reduced central lumen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Percutaneous Isolated Localized Perfusion, PILP, Isolated Hepatic Perfusion, IHP, Liver metastases, Unresectable liver metastases of different etiologies