Clinical Trial Details

NCT ID: NCT01250158
Date Last Changed: March 28, 2013

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Liver Metastases

Research Study Title

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

Purpose

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.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Medical Device Works NV SA
Duration
40 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (3)

Country State City Zip Facility and Contact
Belgium Brussels 1200 University Hospital Louvain Saint-Luc
Marc Van den Eynce, MD
+3227641902
Marc.VandenEynde@UCLouvain.be

Pierre Goffette, Prof MD
Sub-Investigator

Marie-Agnes Docquier, MD
Sub-Investigator

Michel Van Boven, Prof MD
Sub-Investigator

Amine Matta, Prof MD
Sub-Investigator

Audrey Pospiech, MD
Sub-Investigator

Renaud Lhommel, MD
Sub-Investigator
Belgium Ghent 9000 University Hospital Ghent
Luc Defreyne, Prof MD PhD
+3293322937
Luc.Defreyne@UGent.be

Elilsabeth Dhondt, MD
Sub-Investigator

Patrick Wouters, Prof MD Phd
Sub-Investigator

Filip De Somer, Prof RN Phd
Sub-Investigator

Sylvie Rottey, Prof MD PhD
Sub-Investigator
Belgium Leuven 3000 University Hospitals Leuven, Catholic University
Eric Van Cutsem, Prof MD PhD
+32 16 344218
Eric.VanCutsem@uz.kuleuven.ac.be

Chris Verslype, Prof MD Phd
Sub-Investigator

Geert Maleux, Prof MD PhD
Sub-Investigator

Marc Van de Velde, Prof MD PhD
Sub-Investigator

Diethard Monbaliu, Prof MD PhD
Sub-Investigator

Contact

Eric Van Cutsem, Prof MD PhD
+32 16 344218
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.