Status:
UNKNOWN
Liver-PILP First-in-Man
Lead Sponsor:
Medical Device Works NV SA
Collaborating Sponsors:
Celerion
Cromsource
Conditions:
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
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 treatme...
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 ...
Eligibility Criteria
Inclusion
- Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1
- Unresectable metastatic disease predominant in the liver
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01250158
Start Date
September 1 2010
Last Update
March 29 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Louvain Saint-Luc
Brussels, Belgium, 1200
2
University Hospital Ghent
Ghent, Belgium, 9000
3
University Hospitals Leuven, Catholic University
Leuven, Belgium, 3000