Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-02 @ 9:25 AM
Study NCT ID:
NCT01022359
Status:
COMPLETED
Last Update Posted:
2021-04-22
First Post:
2009-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
Sponsor:
Organization:
Raw JSON
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the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}], 'classes': [{'categories': [{'measurements': [{'value': '277', 'spread': '79', 'groupId': 'OG000'}, {'value': '383', 'spread': '82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First haemodialysis session after insertion', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Achievement of Flow Rates>=450ml/Min at Dialysis Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]\n\nTesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access'}, {'id': 'OG001', 'title': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}], 'classes': [{'categories': [{'measurements': [{'value': '361', 'spread': '48', 'groupId': 'OG000'}, {'value': '379', 'spread': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'flow rate measured at each session; session at 12 months reported', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Line Retention (Either/Both Lumens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]\n\nTesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access'}, {'id': 'OG001', 'title': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'measure not taken'}, {'type': 'SECONDARY', 'title': 'Infective Episodes (Catheter & Non-catheter Related)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]\n\nTesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access'}, {'id': 'OG001', 'title': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'measure not collected'}, {'type': 'SECONDARY', 'title': 'Catheter Dysfunction Requiring Use of Thrombolytic Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]\n\nTesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access'}, {'id': 'OG001', 'title': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'thrombolytic infusions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications at Catheter Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]\n\nTesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access'}, {'id': 'OG001', 'title': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'complications at insertion', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recirculation Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]\n\nTesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access'}, {'id': 'OG001', 'title': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'measure not taken'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]\n\nTesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access'}, {'id': 'FG001', 'title': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]\n\nTesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access'}, {'id': 'BG001', 'title': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)\n\nLifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.3', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '16.4', 'groupId': 'BG001'}, {'value': '61', 'spread': '16.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2009-11-30', 'resultsFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-26', 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Flow Rate at First Use After Insertion', 'timeFrame': 'First haemodialysis session after insertion'}], 'secondaryOutcomes': [{'measure': 'Achievement of Flow Rates>=450ml/Min at Dialysis Session', 'timeFrame': 'flow rate measured at each session; session at 12 months reported'}, {'measure': 'Line Retention (Either/Both Lumens)', 'timeFrame': '12 months'}, {'measure': 'Infective Episodes (Catheter & Non-catheter Related)', 'timeFrame': '12 months'}, {'measure': 'Catheter Dysfunction Requiring Use of Thrombolytic Agents', 'timeFrame': '12 months'}, {'measure': 'Complications at Catheter Insertion', 'timeFrame': 'Day 1'}, {'measure': 'Recirculation Rates', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['haemodialysis', 'vascular access', 'central venous catheter'], 'conditions': ['Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '15340094', 'type': 'BACKGROUND', 'citation': 'Duncan ND, Singh S, Cairns TD, Clark M, El-Tayar A, Griffith M, Hakim N, Hamady M, McLean AG, Papalois V, Palmer A, Taube D. Tesio-Caths provide effective and safe long-term vascular access. Nephrol Dial Transplant. 2004 Nov;19(11):2816-22. doi: 10.1093/ndt/gfh467. Epub 2004 Aug 31.'}, {'pmid': '10751478', 'type': 'BACKGROUND', 'citation': 'Perini S, LaBerge JM, Pearl JM, Santiestiban HL, Ives HE, Omachi RS, Graber M, Wilson MW, Marder SR, Don BR, Kerlan RK Jr, Gordon RL. Tesio catheter: radiologically guided placement, mechanical performance, and adequacy of delivered dialysis. Radiology. 2000 Apr;215(1):129-37. doi: 10.1148/radiology.215.1.r00mr43129.'}, {'pmid': '10357479', 'type': 'BACKGROUND', 'citation': 'Hassell DD 3rd, Vesely TM, Pilgram TK, Audrain JL. Initial performance of Tesio hemodialysis catheters. J Vasc Interv Radiol. 1999 May;10(5):553-8. doi: 10.1016/s1051-0443(99)70082-5.'}, {'pmid': '24500851', 'type': 'RESULT', 'citation': 'Power A, Hill P, Singh SK, Ashby D, Taube D, Duncan N. Comparison of Tesio and LifeCath twin permanent hemodialysis catheters: the VyTes randomized trial. J Vasc Access. 2014 Mar-Apr;15(2):108-15. doi: 10.5301/jva.5000202. Epub 2014 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare two available types of central venous haemodialysis catheters (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on dialysis over time, line loss, line clotting and infective events. It will examine whether the LifeCath type of CVC can deliver high blood flow rates from first use after insertion and equivalent function and complication rate to the Tesio type of CVC that is in use in our centre already. Complications relating to dialysis access make up 30% of admissions for haemodialysis patients and so this is a study that could benefit patients and their care providers.', 'detailedDescription': 'Complications relating to dialysis access make up to 30% of admissions in haemodialysis patients. Comparative studies of complications between dialysis lines can help physicians and patients choose the best CVC type. In addition determining a type of dialysis line that can deliver good blood flows from the outset can minimise length of hospital stay for access creation. This study aims to perform a head-to-head comparison of two very similar (twin catheter) dialysis lines and examine short and long-term function as well as complication rates at our centre.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years old\n* No history of prior central venous catheter insertion\n* Medically fit for procedure (able to lie flat, no haemodynamic instability)\n* No active infection (recent positive blood cultures, clinical signs of infection, CRP\\>100)\n* Able to give informed consent\n* Expected to survive more than 12 months after catheter insertion\n\nExclusion Criteria:\n\n* As above'}, 'identificationModule': {'nctId': 'NCT01022359', 'acronym': 'VyTes', 'briefTitle': 'Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College Healthcare NHS Trust'}, 'officialTitle': 'Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters', 'orgStudyIdInfo': {'id': '08/H0710/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tesio Catheter', 'description': 'Patients randomised to receive the established catheter type in use at our centre \\[control\\]', 'interventionNames': ['Device: TesioCath']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LifeCath', 'description': 'Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)', 'interventionNames': ['Device: LifeCath Twin']}], 'interventions': [{'name': 'TesioCath', 'type': 'DEVICE', 'otherNames': ['BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA'], 'description': 'Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access', 'armGroupLabels': ['Tesio Catheter']}, {'name': 'LifeCath Twin', 'type': 'DEVICE', 'otherNames': ['Vygon LifeCath Twin - Vygon(UK) Ltd, Cirencester, Gloucs, UK'], 'description': 'Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access', 'armGroupLabels': ['LifeCath']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Neill Duncan, MBBS MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}, {'name': 'Albert Power, MBBChir MRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}