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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Medical Device Works NV SA
Sponsor:
Collaborators:
Celerion
CROMSOURCE
Information provided by (Responsible Party):
Medical Device Works NV SA
ClinicalTrials.gov Identifier:
NCT01250158
First received: November 26, 2010
Last updated: March 28, 2013
Last verified: March 2013
  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.


Condition Intervention
Liver Metastases
Device: Liver-PILP kit

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases

Resource links provided by NLM:


Further study details as provided by Medical Device Works NV SA:

Primary Outcome Measures:
  • To demonstrate the feasibility of the liver PILP intervention. [ Time Frame: During intervention and up to 30 days post intervention ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 6
Study Start Date: September 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liver-PILP kit
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250158

Contacts
Contact: Eric Van Cutsem, Prof MD PhD +32 16 344218 Eric.VanCutsem@uz.kuleuven.ac.be

Locations
Belgium
University Hospital Louvain Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Marc Van den Eynce, MD    +3227641902    Marc.VandenEynde@UCLouvain.be   
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         
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Luc Defreyne, Prof MD PhD    +3293322937    Luc.Defreyne@UGent.be   
Contact: Karen Geboes, Prof MD PhD    +3293322374    Karen.Geboes@UZGent.be   
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         
University Hospitals Leuven, Catholic University Recruiting
Leuven, Belgium, 3000
Contact: Eric Van Cutsem, Prof MD PhD    +32 16 344218    Eric.VanCutsem@uz.kuleuven.ac.be   
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         
Sponsors and Collaborators
Medical Device Works NV SA
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
  More Information

No publications provided

Responsible Party: Medical Device Works NV SA
ClinicalTrials.gov Identifier: NCT01250158     History of Changes
Other Study ID Numbers: CIP 000369
Study First Received: November 26, 2010
Last Updated: March 28, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Medical Device Works NV SA:
Liver Percutaneous Isolated Localized Perfusion
PILP
Isolated Hepatic Perfusion
IHP
Liver metastases
Unresectable liver metastases of different etiologies

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Liver Extracts
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014