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Brief Title: Liver-PILP First-in-Man
Official Title: First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases
Study ID: NCT01250158
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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital Louvain Saint-Luc, Brussels, , Belgium
University Hospital Ghent, Ghent, , Belgium
University Hospitals Leuven, Catholic University, Leuven, , Belgium
Name: Eric Van Cutsem, Prof MD PhD
Affiliation: University Hospitals Leuven, Catholic University
Role: PRINCIPAL_INVESTIGATOR
Name: Karen Geboes, Prof MD Phd
Affiliation: University Hospital, Ghent
Role: PRINCIPAL_INVESTIGATOR
Name: Luc Defreyne, Prof MD PhD
Affiliation: University Hospital, Ghent
Role: PRINCIPAL_INVESTIGATOR
Name: Marc Van den Eynde, MD
Affiliation: University Hospital Louvain Saint-Luc
Role: PRINCIPAL_INVESTIGATOR