Liver-PILP First-in-Man (PILP FiM)

Medical Device Works

Status: Unknown

Conditions: Liver Metastases

Treatments: Device: Liver-PILP kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT01250158

CIP 000369

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

6 participants in 1 patient group

Liver-PILP kit

Experimental group

Description:

Liver-PILP kit

Treatment:

Device: Liver-PILP kit