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


N/A
18 Years
N/A
Open (Enrolling)
Both
Liver Metastases

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To demonstrate the feasibility of the liver PILP intervention.

Outcome Description:

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.

Outcome Time Frame:

During intervention and up to 30 days post intervention

Safety Issue:

Yes

Principal Investigator

Eric Van Cutsem, Prof MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals Leuven, Catholic University

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

CIP 000369

NCT ID:

NCT01250158

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Liver Metastases
  • Liver Percutaneous Isolated Localized Perfusion
  • PILP
  • Isolated Hepatic Perfusion
  • IHP
  • Liver metastases
  • Unresectable liver metastases of different etiologies
  • Neoplasm Metastasis
  • Liver Neoplasms

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