Liver-PILP First-in-Man (PILP FiM)

March 28, 2013 updated by: Medical Device Works NV SA

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • University Hospital Louvain Saint-Luc
        • Contact:
        • Sub-Investigator:
          • 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
      • Ghent, Belgium, 9000
        • Recruiting
        • University Hospital Ghent
        • Contact:
        • Contact:
        • Sub-Investigator:
          • 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
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven, Catholic University
        • Contact:
        • Sub-Investigator:
          • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liver-PILP kit
Device: Liver-PILP kit

Device: Liver-PILP kit The Liver-PILP kit (three devices) is composed of percutaneous, disposable (single-use), catheter-based devices for targeted, isolated, organ specific (liver), drug delivery and perfusion with high dose drugs.

  1. The Portal Vein Device (PVD): balloon catheter to occlude the portal vein and allow aspiration through a central lumen for portal veno-venous bypass.
  2. The Hepatic Artery Device (HAD): balloon catheter to occlude arterial flow to the liver.
  3. The Vena Cava Device (VCD): catheter based device to isolate and access hepatic outflow to vena cava by creating a closed chamber in vena cava at ostia of the hepatic veins while maintaining central vena cava blood flow from lower extremities to right atrium through reduced central lumen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To demonstrate the feasibility of the liver PILP intervention.
Time Frame: During intervention and up to 30 days post intervention
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.
During intervention and up to 30 days post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Device Works NV SA

Collaborators

Celerion
Cromsource

Investigators

  • Principal Investigator: Eric Van Cutsem, Prof MD PhD, University Hospitals Leuven, Catholic University
  • Principal Investigator: Karen Geboes, Prof MD Phd, University Hospital, Ghent
  • Principal Investigator: Luc Defreyne, Prof MD PhD, University Hospital, Ghent
  • Principal Investigator: Marc Van den Eynde, MD, University Hospital Louvain Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

November 26, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 28, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP 000369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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