Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
Study NCT ID:
NCT01333761
Status:
TERMINATED
Last Update Posted:
2013-01-09
First Post:
2011-03-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiox Shunt Detection Technology Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2014-01-08', 'unreleaseDateUnknown': True}, {'resetDate': '2014-03-11', 'releaseDate': '2014-01-27'}], 'estimatedResultsFirstSubmitDate': '2014-01-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054092', 'term': 'Foramen Ovale, Patent'}], 'ancestors': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'whyStopped': '1)new FDS device design 2)improved Valsalva procedure 3)improved headbands and earpads.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-08', 'studyFirstSubmitDate': '2011-03-31', 'studyFirstSubmitQcDate': '2011-04-11', 'lastUpdatePostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the Cardiox FDS system using TCD as a non-reference standard for positive percent agreement for accurately detecting a RTLS and negative percent agreement for accurately detecting the absence of RTLS', 'timeFrame': '1 day'}, {'measure': 'To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['right to left cardiac shunt finding'], 'conditions': ['Patent Foramen Ovale']}, 'referencesModule': {'references': [{'pmid': '9576637', 'type': 'BACKGROUND', 'citation': 'Karttunen V, Ventila M, Hillbom M, Salonen O, Haapaniemi H, Kaste M. Dye dilution and oximetry for detection of patent foramen ovale. Acta Neurol Scand. 1998 Apr;97(4):231-6. doi: 10.1111/j.1600-0404.1998.tb00643.x.'}, {'pmid': '15358955', 'type': 'BACKGROUND', 'citation': 'Spencer MP, Moehring MA, Jesurum J, Gray WA, Olsen JV, Reisman M. Power m-mode transcranial Doppler for diagnosis of patent foramen ovale and assessing transcatheter closure. J Neuroimaging. 2004 Oct;14(4):342-9. doi: 10.1177/1051228404268743.'}]}, 'descriptionModule': {'briefSummary': 'The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against transesophageal echocardiography (TEE) for sensitivity and specificity, as well as transcranial doppler (TCD) for positive percent agreement and negative percent agreement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eighteen (18) years of age or older\n* Informed consent documentation understood and signed\n* Planned or completed TEE study within the last 12 months\n\nExclusion Criteria:\n\n* Subjects with a known allergy or sensitivity to Indocyanine Green Dye (ICG) or to Iodide Contrast Dye or Iodides\n* Pregnant women or nursing mothers\n* Subject unable or unwilling to understand and sign the informed consent\n* Subject scheduled for radioactive iodine uptake test (Thyroid test) within 7 days of post screening\n* Subjects that have poor renal function such as subjects on dialysis, subjects with a recent history of creatinine \\> 2.0 or subjects currently being followed by a nephrologist'}, 'identificationModule': {'nctId': 'NCT01333761', 'briefTitle': 'Cardiox Shunt Detection Technology Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiox Corporation'}, 'officialTitle': 'FDS-0004 Cardiox Shunt Detection Technology Study', 'orgStudyIdInfo': {'id': 'FDS-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCD/Cardiox FDS/TEE testing', 'description': 'All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS.', 'interventionNames': ['Device: Cardiox FDS']}], 'interventions': [{'name': 'Cardiox FDS', 'type': 'DEVICE', 'description': 'The Cardiox Shunt Detection system consists of a sensor placed in contact with the outer ear, similar to a finger probe used to detect oxygen levels in blood. Through an intravenous line, ICG (indocyanine green) at a dosage of 10 mg (2 mL of 5 mg/mL ICG solution) per test, is administered into the right or left antecubital fossa. The presence of ICG in the veins within the outer ear are detected, and the results are displayed on a monitor. All patients will also be evaluated with TCD and TEE for the presence of RTLS.', 'armGroupLabels': ['TCD/Cardiox FDS/TEE testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama, Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Heart and Vascular Center of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverside Methodist Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Hospital', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiox Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-01-08', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2014-01-27', 'type': 'RELEASE'}, {'date': '2014-03-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Cardiox Corporation'}}}}