Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-04-18 @ 2:55 PM
Study NCT ID:
NCT03209050
Status:
COMPLETED
Last Update Posted:
2023-05-30
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Surfacer System Approach to Central Venous Access
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura22@mmc-medical.com', 'phone': '9492805700', 'title': 'Clinical Research Organization and Trial Manager', 'organization': 'mmc medical international services'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks or 30 days', 'description': 'Overall number of participants who experienced adverse events as a result of the access procedure per definitions within 24 hours of occurrence.', 'eventGroups': [{'id': 'EG000', 'title': 'Central Venous Access Placement', 'description': 'Central venous access placement\n\nCentral Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'allergic reaction', 'notes': 'one allergic reaction occurred rated as mild adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'allergic reaction'}], 'seriousEvents': [{'term': 'Hypotension', 'notes': 'Hypovolemia causing Hypotension post dialysis, resolved with inpatient hospitalization greater than 24 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hypotension'}, {'term': 'Bleeding', 'notes': 'Bleeding requiring transfusion and narcan and colloidal solution. In patient hospitalization greater than 24 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'bleeding'}, {'term': 'Hemodynamic Instability', 'notes': 'low blood pressure requiring vasopressors, extended hospitalization greater than 24 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'hemodynamic unstable'}, {'term': 'unintended embolization', 'notes': 'anticoagulants administered, in patient hospitalization greater than 24 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'embolization'}, {'term': 'bleeding', 'notes': 'bleeding at the central venous access site, resolved with transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'bleeding'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Central Venous Access Placement', 'description': 'Central venous access placement in 26/30 patients\n\nCentral Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter in 26/30 patients'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000'], 'statisticalMethod': 'Clopper-Pearson 95% CI', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Central Venous Access Placement', 'description': 'Central venous access placement in 27/30 patients\n\nCentral Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter in 27/30 patients'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Safety and Efficacy 90.0% (27/30) successful central venous catheter placements as assessed by patent open central venous access catheter. Ability to use the central venous access catheter for dialysis and infusion through 7 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'patients treated with central venous access device'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Central Venous Access Placement', 'description': 'Central venous access placement\n\nCentral Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Central Venous Access Placement', 'description': 'Central venous access placement\n\nCentral Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'chronic Kidney disease', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'patients with central venous disease with pathology impeding standard access methods'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-07', 'size': 5776806, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-30T15:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'patients requiring venous access'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2017-06-16', 'resultsFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-21', 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter', 'timeFrame': '7 days', 'description': 'Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted', 'timeFrame': '7 days', 'description': 'Safety and Efficacy 90.0% (27/30) successful central venous catheter placements as assessed by patent open central venous access catheter. Ability to use the central venous access catheter for dialysis and infusion through 7 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Venous Occlusion']}, 'descriptionModule': {'briefSummary': 'Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter.', 'detailedDescription': 'This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of the Surfacer System. Safety will be evaluated based on the overall rate of acute complications using the study device as compared to historical rates of device/procedure related safety events using conventional central venous access methods. Efficacy will be evaluated by the rate of transient successful central venous accesses created by the study device. A total of 30 patients are planned to be enrolled, with 10 patients initially following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites will participate in the study in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* referred for placement of central venous access catheter\n* have limited or diminishing upper body venous access\n* have pathology impeding standard access methods\n* willing to give written informed consent\n\nExclusion Criteria:\n\n* occlusion of the right femoral vein\n* occlusion of the iliac vein\n* occlusion of the inferior vena cava\n* contraindicated by physician\n* acute thrombosis within any vessel planned to be crossed by the Surfacer \\*tortuous anatomy which precludes a straight line from femoral vein to subclavian\n* diagnosed with active pericarditis\n* diagnosed with active endocarditis\n* suspected pericardial effusion\n* known or suspected aneurysm or ectasia of ascending aorta\n* innominate artery or subclavian artery\n* pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study'}, 'identificationModule': {'nctId': 'NCT03209050', 'acronym': 'SAVEUS', 'briefTitle': 'Evaluation of the Surfacer System Approach to Central Venous Access', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merit Medical Systems, Inc.'}, 'officialTitle': 'Evaluation of the Surfacer System Approach to Central Venous Access', 'orgStudyIdInfo': {'id': 'BVT.Surfacer.17-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Central Venous Access Placement', 'description': 'Central venous access placement', 'interventionNames': ['Device: Central Venous Access Placement']}], 'interventions': [{'name': 'Central Venous Access Placement', 'type': 'DEVICE', 'description': 'Device inserted into the femoral vein to insert a central venous access catheter', 'armGroupLabels': ['Central Venous Access Placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Monica Tocchi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Meditrial Europe Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merit Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Meditrial Europe Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}