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Liver-PILP First-in-Man

NCT01250158 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-03-29

No results posted yet for this study

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.

Conditions

  • Liver Metastases

Interventions

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.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Cromsource

    collaborator INDUSTRY

  • Medical Device Works NV SA

    lead INDUSTRY

Principal Investigators

  • Eric Van Cutsem, Prof MD PhD · University Hospitals Leuven, Catholic University

  • Karen Geboes, Prof MD Phd · University Hospital, Ghent

  • Luc Defreyne, Prof MD PhD · University Hospital, Ghent

  • Marc Van den Eynde, MD · University Hospital Louvain Saint-Luc

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01250158 on ClinicalTrials.gov