Liver-PILP First-in-Man (PILP FiM)
This study is currently recruiting participants.
Verified March 2013 by Medical Device Works NV SA
Sponsor:
Medical Device Works NV SA
Collaborators:
Celerion
CROMSOURCE
Information provided by (Responsible Party):
Medical Device Works NV SA
ClinicalTrials.gov Identifier:
NCT01250158
First received: November 26, 2010
Last updated: March 28, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Liver Metastases |
Device: Liver-PILP kit |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases |
Further study details as provided by Medical Device Works NV SA:
Primary Outcome Measures:
- To demonstrate the feasibility of the liver PILP intervention. [ Time Frame: During intervention and up to 30 days post intervention ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 6 |
| Study Start Date: | September 2010 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Liver-PILP kit
Liver-PILP kit
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1
- Unresectable metastatic disease predominant in the liver
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250158
Contacts
| Contact: Eric Van Cutsem, Prof MD PhD | +32 16 344218 | Eric.VanCutsem@uz.kuleuven.ac.be |
Locations
| Belgium | |
| University Hospital Louvain Saint-Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Contact: Marc Van den Eynce, MD +3227641902 Marc.VandenEynde@UCLouvain.be | |
| Sub-Investigator: Pierre Goffette, Prof MD | |
| Sub-Investigator: Marie-Agnes Docquier, MD | |
| Sub-Investigator: Michel Van Boven, Prof MD | |
| Sub-Investigator: Amine Matta, Prof MD | |
| Sub-Investigator: Audrey Pospiech, MD | |
| Sub-Investigator: Renaud Lhommel, MD | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Luc Defreyne, Prof MD PhD +3293322937 Luc.Defreyne@UGent.be | |
| Contact: Karen Geboes, Prof MD PhD +3293322374 Karen.Geboes@UZGent.be | |
| Sub-Investigator: Elilsabeth Dhondt, MD | |
| Sub-Investigator: Patrick Wouters, Prof MD Phd | |
| Sub-Investigator: Filip De Somer, Prof RN Phd | |
| Sub-Investigator: Sylvie Rottey, Prof MD PhD | |
| University Hospitals Leuven, Catholic University | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Eric Van Cutsem, Prof MD PhD +32 16 344218 Eric.VanCutsem@uz.kuleuven.ac.be | |
| Sub-Investigator: Chris Verslype, Prof MD Phd | |
| Sub-Investigator: Geert Maleux, Prof MD PhD | |
| Sub-Investigator: Marc Van de Velde, Prof MD PhD | |
| Sub-Investigator: Diethard Monbaliu, Prof MD PhD | |
Sponsors and Collaborators
Medical Device Works NV SA
Celerion
CROMSOURCE
Investigators
| Principal Investigator: | Eric Van Cutsem, Prof MD PhD | University Hospitals Leuven, Catholic University |
| Principal Investigator: | Karen Geboes, Prof MD Phd | University Hospital, Ghent |
| Principal Investigator: | Luc Defreyne, Prof MD PhD | University Hospital, Ghent |
| Principal Investigator: | Marc Van den Eynde, MD | University Hospital Louvain Saint-Luc |
More Information
No publications provided
| Responsible Party: | Medical Device Works NV SA |
| ClinicalTrials.gov Identifier: | NCT01250158 History of Changes |
| Other Study ID Numbers: | CIP 000369 |
| Study First Received: | November 26, 2010 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products |
Keywords provided by Medical Device Works NV SA:
|
Liver Percutaneous Isolated Localized Perfusion PILP Isolated Hepatic Perfusion |
IHP Liver metastases Unresectable liver metastases of different etiologies |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases Liver Extracts Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013