Liver-PILP First-in-Man

Liver Metastases Clinical Trial

— PILP FiM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01250158
• Other study ID #: CIP 000369
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2010
• Last updated: March 28, 2013
• Start date: September 2010

Study information

• Verified date: March 2013
• Source: Medical Device Works NV SA
• Contact: Eric Van Cutsem, Prof MD PhD
• Phone: +32 16 344218
• Email: Eric.VanCutsem[@]uz.kuleuven.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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. 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.

Locations

Country	Name	City	State
Belgium	University Hospital Louvain Saint-Luc	Brussels
Belgium	University Hospital Ghent	Ghent
Belgium	University Hospitals Leuven, Catholic University	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Medical Device Works NV SA	Celerion, Cromsource

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During intervention and up to 30 days post intervention	Yes