Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-28 @ 7:32 PM
Study NCT ID:
NCT02606734
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DyeVert Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017023', 'term': 'Coronary Angiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000792', 'term': 'Angiography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D006334', 'term': 'Heart Function Tests'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mshepard@ospreymed.com', 'phone': '952-955-5236', 'title': 'Michele Shepard', 'organization': 'Osprey Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AE Reporting occurred through the subjects discharge from the index procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': 'All subjects enrolled in the trial will use the DyeVert System.\n\nCoronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'All subjects enrolled in the trial will use the DyeVert System.\n\nCoronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'spread': '8.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': 'The subject is exited from the study once they are discharged.', 'unitOfMeasure': 'percent of contrast media saved', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm', 'description': 'All subjects enrolled in the trial will use the DyeVert System.\n\nCoronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Enrollment on 10/26/2015, Last Enrollment on 11/19/2015', 'preAssignmentDetails': 'Subjects undergoing a coronary artery imaging (angiogram) for diagnostic or percutaneous coronary intervention (PCI) procedures are eligible to participate in this study. All data will be collected on the day of the procedure. There are no follow-up visits in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'All subjects enrolled in the trial will use the DyeVert System.\n\nCoronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.3', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-19', 'studyFirstSubmitDate': '2015-10-28', 'resultsFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2015-11-13', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-27', 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure', 'timeFrame': '1 Day', 'description': 'The subject is exited from the study once they are discharged.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Angiography']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject is indicated for a coronary angiogram or percutaneous coronary procedure\n2. The subject is ≥ 18 years of age\n3. The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.\n\nExclusion Criteria:\n\n1. Subject is undergoing a STEMI procedure\n2. The subject is female and currently pregnant\n3. In the investigator's opinion, the subject is not considered to be a suitable candidate"}, 'identificationModule': {'nctId': 'NCT02606734', 'briefTitle': 'DyeVert Pilot Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Osprey Medical, Inc'}, 'officialTitle': 'DyeVert Pilot Trial', 'orgStudyIdInfo': {'id': 'TP-6463'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Arm', 'description': 'All subjects enrolled in the trial will use the DyeVert System.', 'interventionNames': ['Device: Coronary Angiography']}], 'interventions': [{'name': 'Coronary Angiography', 'type': 'DEVICE', 'description': 'The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Health', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'University Hospital of Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osprey Medical, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}