Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT01250158
Status:
UNKNOWN
Last Update Posted:
2013-03-29
First Post:
2010-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liver-PILP First-in-Man
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-28', 'studyFirstSubmitDate': '2010-11-26', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the feasibility of the liver PILP intervention.', 'timeFrame': 'During intervention and up to 30 days post intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver Percutaneous Isolated Localized Perfusion', 'PILP', 'Isolated Hepatic Perfusion', 'IHP', 'Liver metastases', 'Unresectable liver metastases of different etiologies'], 'conditions': ['Liver Metastases']}, 'referencesModule': {'references': [{'pmid': '20495978', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The objective of this Medical Device Study, is to demonstrate the feasibility of the liver PILP intervention.\n\nThe liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1\n2. Unresectable metastatic disease predominant in the liver\n\nExclusion Criteria:\n\n1. More than 60 % tumor involved liver tissue\n2. Abnormal vascular anatomy\n3. Severe atherosclerosis\n4. Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries\n5. Short suprahepatic vena cava segment (\\< 1.5 cm)\n6. One or both jugular veins are occluded\n7. Other severe, concomitant diseases regarding the subject status'}, 'identificationModule': {'nctId': 'NCT01250158', 'acronym': 'PILP FiM', 'briefTitle': 'Liver-PILP First-in-Man', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medical Device Works NV SA'}, 'officialTitle': 'First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases', 'orgStudyIdInfo': {'id': 'CIP 000369'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liver-PILP kit', 'description': 'Liver-PILP kit', 'interventionNames': ['Device: Liver-PILP kit']}], 'interventions': [{'name': 'Liver-PILP kit', 'type': 'DEVICE', 'description': '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.\n\n1. The Portal Vein Device (PVD): balloon catheter to occlude the portal vein and allow aspiration through a central lumen for portal veno-venous bypass.\n2. The Hepatic Artery Device (HAD): balloon catheter to occlude arterial flow to the liver.\n3. 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.', 'armGroupLabels': ['Liver-PILP kit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Marc Van den Eynce, MD', 'role': 'CONTACT', 'email': 'Marc.VandenEynde@UCLouvain.be', 'phone': '+3227641902'}, {'name': 'Pierre Goffette, Prof MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marie-Agnes Docquier, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michel Van Boven, Prof MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amine Matta, Prof MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Audrey Pospiech, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Renaud Lhommel, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Louvain Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Luc Defreyne, Prof MD PhD', 'role': 'CONTACT', 'email': 'Luc.Defreyne@UGent.be', 'phone': '+3293322937'}, {'name': 'Karen Geboes, Prof MD PhD', 'role': 'CONTACT', 'email': 'Karen.Geboes@UZGent.be', 'phone': '+3293322374'}, {'name': 'Elilsabeth Dhondt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patrick Wouters, Prof MD Phd', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Filip De Somer, Prof RN Phd', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sylvie Rottey, Prof MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Eric Van Cutsem, Prof MD PhD', 'role': 'CONTACT', 'email': 'Eric.VanCutsem@uz.kuleuven.ac.be', 'phone': '+32 16 344218'}, {'name': 'Chris Verslype, Prof MD Phd', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Geert Maleux, Prof MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marc Van de Velde, Prof MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Diethard Monbaliu, Prof MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospitals Leuven, Catholic University', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Eric Van Cutsem, Prof MD PhD', 'role': 'CONTACT', 'email': 'Eric.VanCutsem@uz.kuleuven.ac.be', 'phone': '+32 16 344218'}], 'overallOfficials': [{'name': 'Eric Van Cutsem, Prof MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Leuven, Catholic University'}, {'name': 'Karen Geboes, Prof MD Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}, {'name': 'Luc Defreyne, Prof MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}, {'name': 'Marc Van den Eynde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Louvain Saint-Luc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Device Works NV SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Celerion', 'class': 'INDUSTRY'}, {'name': 'Cromsource', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}