Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-26 @ 10:45 AM
Study NCT ID:
NCT05476250
Status:
TERMINATED
Last Update Posted:
2025-05-13
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studies@masimo.com', 'phone': '949-297-7000', 'title': 'Ahmed Alghazi', 'organization': 'Masimo Coporation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1-5 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Masimo INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Masimo INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': 'Specificity refers to the ability of Masimo INVSENSOR00057 to correctly identify individuals who do not have atrial fibrillation. High specificity is important in minimizing false positives.', 'unitOfMeasure': '% of true negatives', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject not analyzed due to EDC error.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Masimo INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Masimo INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '98', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-04', 'size': 9435559, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-22T14:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'whyStopped': 'The validation protocol is no longer needed for regulatory submission.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'dispFirstSubmitDate': '2023-08-09', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2022-07-25', 'resultsFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2022-07-25', 'dispFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-25', 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function', 'timeFrame': '1-5 hours', 'description': 'Specificity refers to the ability of Masimo INVSENSOR00057 to correctly identify individuals who do not have atrial fibrillation. High specificity is important in minimizing false positives.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject is 18 to 80 years of age.\n* Subject can read and communicate in English.\n* Subject's cardiac rhythm shall be Normal Sinus Rhythm or Atrial Fibrillation (Afib). This determination will be made using FDA cleared 3-lead ECG which will label subject's cardiac rhythm as such.\n\nExclusion Criteria:\n\n* Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.\n* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff."}, 'identificationModule': {'nctId': 'NCT05476250', 'briefTitle': 'Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection', 'orgStudyIdInfo': {'id': 'CIP-1022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057.', 'interventionNames': ['Device: INVSENSOR00057']}], 'interventions': [{'name': 'INVSENSOR00057', 'type': 'DEVICE', 'description': 'Noninvasive wearable health monitoring device', 'armGroupLabels': ['INVSENSOR00057']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Masimo Corporation', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}