Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-24 @ 6:14 AM
Study NCT ID:
NCT02376361
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hemodialysis Access Surveillance Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'SalmanL@amc.edu', 'phone': '518-262-5176', 'title': 'Loay Salman, MD', 'organization': 'Albany Medical College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study did not achieve targeted numbers for enrollment.'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Surveillance Group', 'description': 'Monthly standard of care and blood flow surveillance for the duration of the study', 'otherNumAtRisk': 229, 'deathsNumAtRisk': 229, 'otherNumAffected': 0, 'seriousNumAtRisk': 229, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Monthly standard of care for the duration of the study', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 0, 'seriousNumAtRisk': 207, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemodialysis Access Thrombosis Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surveillance Group', 'description': 'Monthly blood flow surveillance by ultrasound dilution technique and standard of care.\n\nTransonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).\n\n1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines\n2. Recirculation, access flow will be performed according to HD03 Manual.\n3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group will receive standard monitoring (standard care).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.122', 'groupId': 'OG000', 'lowerLimit': '0.081', 'upperLimit': '0.177'}, {'value': '0.227', 'groupId': 'OG001', 'lowerLimit': '0.167', 'upperLimit': '0.302'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'Evaluate the reduction of hemodialysis access thrombosis rate', 'unitOfMeasure': 'thrombotic events per patient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tunneled Hemodialysis Catheter Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surveillance Group', 'description': 'Monthly blood flow surveillance by ultrasound dilution technique and standard of care.\n\nTransonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).\n\n1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines\n2. Recirculation, access flow will be performed according to HD03 Manual.\n3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group will receive standard monitoring (standard care).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.039', 'groupId': 'OG000', 'lowerLimit': '0.018', 'upperLimit': '0.075'}, {'value': '0.053', 'groupId': 'OG001', 'lowerLimit': '0.027', 'upperLimit': '0.095'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'Evaluate the reduction of tunneled hemodialysis catheter rate', 'unitOfMeasure': 'Events per patient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Tunneled Hemodialysis Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surveillance Group', 'description': 'Monthly blood flow surveillance by ultrasound dilution technique and standard of care.\n\nTransonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).\n\n1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines\n2. Recirculation, access flow will be performed according to HD03 Manual.\n3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group will receive standard monitoring (standard care).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hemodialysis Access Thrombectomy Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surveillance Group', 'description': 'Monthly blood flow surveillance by ultrasound dilution technique and standard of care.\n\nTransonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).\n\n1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines\n2. Recirculation, access flow will be performed according to HD03 Manual.\n3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group will receive standard monitoring (standard care).'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'Evaluate the reduction of hemodialysis access thrombectomy procedures', 'unitOfMeasure': 'Procedures', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hemodialysis Access Angiogram and Angioplasty Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surveillance Group', 'description': 'Monthly blood flow surveillance by ultrasound dilution technique and standard of care.\n\nTransonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).\n\n1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines\n2. Recirculation, access flow will be performed according to HD03 Manual.\n3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group will receive standard monitoring (standard care).'}], 'classes': [{'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures', 'unitOfMeasure': 'Procedures', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Surveillance Group', 'description': 'Monthly blood flow surveillance by ultrasound dilution technique and standard of care.\n\nTransonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).\n\n1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines\n2. Recirculation, access flow will be performed according to HD03 Manual.\n3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Control group will receive standard monitoring (standard care).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '207'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '117'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Surveillance Group', 'description': 'Monthly blood flow surveillance by ultrasound dilution technique and standard of care.\n\nTransonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).\n\n1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines\n2. Recirculation, access flow will be performed according to HD03 Manual.\n3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Control group will receive standard monitoring (standard care).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.996', 'spread': '11.855', 'groupId': 'BG000'}, {'value': '61.826', 'spread': '11.942', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'black', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Pacific Islander', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-27', 'size': 160842, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-04T14:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 436}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2015-02-24', 'resultsFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-04', 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodialysis Access Thrombosis Rate', 'timeFrame': 'Up to 24 months', 'description': 'Evaluate the reduction of hemodialysis access thrombosis rate'}], 'secondaryOutcomes': [{'measure': 'Tunneled Hemodialysis Catheter Rate', 'timeFrame': 'Up to 24 months', 'description': 'Evaluate the reduction of tunneled hemodialysis catheter rate'}, {'measure': 'Number of Participants With a Tunneled Hemodialysis Catheter', 'timeFrame': 'Up to 24 months'}, {'measure': 'Number of Hemodialysis Access Thrombectomy Procedures', 'timeFrame': 'Up to 24 months', 'description': 'Evaluate the reduction of hemodialysis access thrombectomy procedures'}, {'measure': 'Number of Hemodialysis Access Angiogram and Angioplasty Procedures', 'timeFrame': 'Up to 24 months', 'description': 'Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Surveillance'], 'conditions': ['Hemodialysis Access', 'Thrombosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting).\n\nInvestigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hemodialysis patients undergoing dialysis therapy via an upper extremity arteriovenous access (arteriovenous fistula or an arteriovenous graft) will be enrolled to have monthly surveillance flow measurement using Transonic system or physical examination of the arteriovenous access by qualified person at least once a month for a period of 2 years.\n\nExclusion Criteria:\n\n* Patients requiring surgical intervention on the arteriovenous access.\n* History of access thrombosis (one or more access thrombosis of the current arteriovenous access).\n* Patients with signs of access infection.\n* Patients with a malignancy.\n* Patients with life expectancy of less than six months.\n* Unable to understand the study.\n* Unable to sign the consent form.\n* Patients with psychiatric disorder.\n* Age less than 18 or greater than 80 years.\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT02376361', 'acronym': 'HASE', 'briefTitle': 'Hemodialysis Access Surveillance Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Hemodialysis Access Surveillance Evaluation Study', 'orgStudyIdInfo': {'id': '20140235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surveillance Group', 'description': 'Monthly blood flow surveillance by ultrasound dilution technique and standard of care.', 'interventionNames': ['Device: Transonic']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group will receive standard monitoring (standard care).'}], 'interventions': [{'name': 'Transonic', 'type': 'DEVICE', 'description': 'Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).\n\n1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines\n2. Recirculation, access flow will be performed according to HD03 Manual.\n3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.', 'armGroupLabels': ['Surveillance Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'North America Research Institute', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'overallOfficials': [{'name': 'Loay Salman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Transonic Systems Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Loay Salman, MD', 'investigatorAffiliation': 'Albany Medical College'}}}}