NCT01250158

Liver-PILP First-in-Man

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Medical Device Works NV SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Metastases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-01-01
• First posted: 2010-11-30
• Last updated: 2013-03-29

Locations

3 sites across 1 country: Belgium