Liver-PILP First-in-Man

Not Applicable

• Conditions: Liver Metastases
• Interventions: Device: Liver-PILP kit

• Registration Number: NCT01250158
• Lead Sponsor: Medical Device Works NV SA

Brief 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-26
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-28
• Last Update Posted: 2013-03-29
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liver-PILP kit	Liver-PILP kit	Liver-PILP kit

Primary Outcome Measures

Name	Time	Method
To demonstrate the feasibility of the liver PILP intervention.	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.

Trial Locations

Locations (3)

University Hospitals Leuven, Catholic University; 🇧🇪 Leuven, Belgium

University Hospital Louvain Saint-Luc; 🇧🇪 Brussels, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium