Liver-PILP First-in-Man
Conditions
Liver Metastases
Conditions: official terms
Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Liver Percutaneous Isolated Localized Perfusion, PILP, Isolated Hepatic Perfusion, IHP, Liver metastases, Unresectable liver metastases of different etiologies
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: Liver-PILP kit
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1

2. Unresectable metastatic disease predominant in the liver

Exclusion Criteria:

1. More than 60 % tumor involved liver tissue

2. Abnormal vascular anatomy

3. Severe atherosclerosis

4. Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries

5. Short suprahepatic vena cava segment (< 1.5 cm)

6. One or both jugular veins are occluded

7. Other severe, concomitant diseases regarding the subject status
Locations
University Hospital Louvain Saint-Luc
Brussels, Belgium
Status: Recruiting
Contact: Marc Van den Eynce, MD - +3227641902 - Marc.VandenEynde@UCLouvain.be
University Hospital Ghent
Ghent, Belgium
Status: Recruiting
Contact: Luc Defreyne, Prof MD PhD - +3293322937 - Luc.Defreyne@UGent.be
University Hospitals Leuven, Catholic University
Leuven, Belgium
Status: Recruiting
Contact: Eric Van Cutsem, Prof MD PhD - +32 16 344218 - Eric.VanCutsem@uz.kuleuven.ac.be
Start Date
September 2010
Sponsors
Medical Device Works NV SA
Source
Medical Device Works NV SA
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page