Liver MetastasesPILP FiMNCT01250158
Liver-PILP First-in-Man
A study testing Liver-PILP kit in people with Liver Metastases, run by Medical Device Works NV SA at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases
- What is being tested?
- Liver-PILP kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesBelgium
- Study dates
- Sep 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1
- Unresectable metastatic disease predominant in the liver
Who cannot join
- More than 60 % tumor involved liver tissue
- Abnormal vascular anatomy
- Severe atherosclerosis
- Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries
- Short suprahepatic vena cava segment (< 1.5 cm)
- One or both jugular veins are occluded
- Other severe, concomitant diseases regarding the subject status
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites, 3 recruiting
- Recruiting
University Hospital Louvain Saint-Luc
Brussels, 1200
Marc Van den Eynce, MD, +3227641902, Marc.VandenEynde@UCLouvain.be
Pierre Goffette, Prof MD
- Recruiting
University Hospital Ghent
Ghent, 9000
Luc Defreyne, Prof MD PhD, +3293322937, Luc.Defreyne@UGent.be
Karen Geboes, Prof MD PhD, +3293322374, Karen.Geboes@UZGent.be
- Recruiting
University Hospitals Leuven, Catholic University
Leuven, 3000
Eric Van Cutsem, Prof MD PhD, +32 16 344218, Eric.VanCutsem@uz.kuleuven.ac.be
Chris Verslype, Prof MD Phd
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Metastases
- Being tested
- Liver-PILP kit
- Keywords
- Liver Percutaneous Isolated Localized Perfusion, PILP, Isolated Hepatic Perfusion, IHP, Liver metastases, Unresectable liver metastases of different etiologies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver-PILP kitDevice
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.
- The Portal Vein Device (PVD): balloon catheter to occlude the portal vein and allow aspiration through a central lumen for portal veno-venous bypass.
- The Hepatic Artery Device (HAD): balloon catheter to occlude arterial flow to the liver.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Liver-PILP kit | Experimental | Liver-PILP kit Receives: Device: Liver-PILP kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the feasibility of the liver PILP 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.
Measured: During intervention and up to 30 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Device Works NV SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion, Cromsource
- Responsible party
- Sponsor
- Investigators
- Eric Van Cutsem, Prof MD PhD, Principal investigator, University Hospitals Leuven, Catholic UniversityKaren Geboes, Prof MD Phd, Principal investigator, University Hospital, GhentLuc Defreyne, Prof MD PhD, Principal investigator, University Hospital, GhentMarc Van den Eynde, MD, Principal investigator, University Hospital Louvain Saint-Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250158
- Sponsor's protocol ID
- CIP 000369
- Acronym
- PILP FiM
- Status last verified
- Mar 2013
- First submitted
- 26 Nov 2010
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maleux G, Monbaliu D, Verslype C, Casteleyn C, Van De Velde M, Cornillie P, Hoogeveen Y, Van Cutsem E. Percutaneous isolated liver perfusion with occlusion balloons and a catheter-based stent-graft-like perfusion device: an experimental study in a porcine model. Eur Radiol. 2010 Oct;20(10):2372-80. doi: 10.1007/s00330-010-1816-5. Epub 2010 May 22.
PubMed 20495978
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases
- ClinicalTrials.gov ID
- NCT01250158
- Acronym / sponsor ID
- PILP FiM / CIP 000369
- Conditions
- Liver Metastases
- Keywords
- Liver Percutaneous Isolated Localized Perfusion, PILP, Isolated Hepatic Perfusion, IHP, Liver metastases, Unresectable liver metastases of different etiologies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Medical Device Works NV SAIndustry (pharma, biotech, devices)
- Collaborators
- Celerion, Cromsource
- Study start
- Sep 2010
- Primary completion
- Jan 2014 (estimated)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver-PILP kit | Experimental | Device: Liver-PILP kitLiver-PILP kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1
- Unresectable metastatic disease predominant in the liver
Key exclusion criteria (7 listed)
- More than 60 % tumor involved liver tissue
- Abnormal vascular anatomy
- Severe atherosclerosis
- Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries
- Short suprahepatic vena cava segment (< 1.5 cm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver-PILP kitDevice: 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. | Device | Liver-PILP kit |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Background: PubMed 20495978Maleux G, Monbaliu D, Verslype C, Casteleyn C, Van De Velde M, Cornillie P, Hoogeveen Y, Van Cutsem E. Percutaneous isolated liver perfusion with occlusion balloons and a catheter-based stent-graft-like perfusion device: an experimental study in a porcine model. Eur Radiol. 2010 Oct;20(10):2372-80. doi: 10.1007/s00330-010-1816-5. Epub 2010 May 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Van Cutsem, Prof MD PhD principal investigator
University Hospitals Leuven, Catholic University
Karen Geboes, Prof MD Phd principal investigator
University Hospital, Ghent
Luc Defreyne, Prof MD PhD principal investigator
University Hospital, Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver-PILP kit in people with Liver Metastases, run by Medical Device Works NV SA at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Van Cutsem, Prof MD PhD (+32 16 344218, Eric.VanCutsem@uz.kuleuven.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the feasibility of the liver PILP intervention. (time frame: During intervention and up to 30 days post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01250158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013; AzTrials last refreshed its copy on 27 Oct 2026.