Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 9:41 AM
Study NCT ID:
NCT05636332
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Intrepid Clinical Engineering Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tiffani.bowers@philips.com', 'phone': '724-989-3072', 'title': 'Tiffani Bowers', 'organization': 'Philips'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'New Electrodes', 'description': 'Unopened package of Electrodes will be applied to participants.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '24-hour Opened Electrodes', 'description': 'Package of Electrodes will be opened 24- hour before applied to participants.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '30 Day Opened Electrodes', 'description': 'Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Validation of Algorithm Software Update', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'New Electrodes', 'description': 'Unopened package of Electrodes will be applied to participants.'}, {'id': 'OG001', 'title': '24-hour Opened Electrodes', 'description': 'Package of Electrodes will be opened 24- hour before applied to participants.'}, {'id': 'OG002', 'title': '30 Day Opened Electrodes', 'description': 'Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 1', 'description': 'Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Diagnostic Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'New Electrodes', 'description': 'Unopened package of Electrodes will be applied to participants.'}, {'id': 'OG001', 'title': '24-hour Opened Electrodes', 'description': 'Package of Electrodes will be opened 24- hour before applied to participants.'}, {'id': 'OG002', 'title': '30 Day Opened Electrodes', 'description': 'Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 1', 'description': 'Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'New Electrodes', 'description': 'Unopened package of Electrodes will be applied to participants.'}, {'id': 'OG001', 'title': '24-hour Opened Electrodes', 'description': 'Package of Electrodes will be opened 24- hour before applied to participants.'}, {'id': 'OG002', 'title': '30 Day Opened Electrodes', 'description': 'Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 1', 'description': 'Participants with frequency and severity of unexpected adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Unanticipated Adverse Device Effects (UADE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'New Electrodes', 'description': 'Unopened package of Electrodes will be applied to participants.'}, {'id': 'OG001', 'title': '24-hour Opened Electrodes', 'description': 'Package of Electrodes will be opened 24- hour before applied to participants.'}, {'id': 'OG002', 'title': '30 Day Opened Electrodes', 'description': 'Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 1', 'description': 'Participants with unanticipated adverse device effects (UADE).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'New Electrodes', 'description': 'Unopened package of Electrodes will be applied to participants.'}, {'id': 'FG001', 'title': '24-hour Opened Electrodes', 'description': 'Package of Electrodes will be opened 24- hour before applied to participants.'}, {'id': 'FG002', 'title': '30 Day Opened Electrodes.', 'description': 'Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'New Electrodes', 'description': 'Unopened package of Electrodes will be applied to participants.'}, {'id': 'BG001', 'title': '24-hour Opened Electrodes', 'description': 'Package of Electrodes will be opened 24- hour before applied to participants.'}, {'id': 'BG002', 'title': '30 Day Opened Electrodes', 'description': 'Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '31.8', 'spread': '19.4', 'groupId': 'BG001'}, {'value': '24.5', 'spread': '17.0', 'groupId': 'BG002'}, {'value': '27.0', 'spread': '18.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Cuban', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Mexican', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Puerto Rican', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '137.2', 'spread': '65.5', 'groupId': 'BG000'}, {'value': '160.3', 'spread': '54.5', 'groupId': 'BG001'}, {'value': '141.1', 'spread': '74.6', 'groupId': 'BG002'}, {'value': '146.2', 'spread': '65.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '61.6', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '12.1', 'groupId': 'BG002'}, {'value': '58.8', 'spread': '12.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '29.4', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '29.0', 'spread': '11.1', 'groupId': 'BG002'}, {'value': '27.9', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Melanin Index', 'classes': [{'categories': [{'measurements': [{'value': '215.9', 'spread': '93.6', 'groupId': 'BG000'}, {'value': '253.8', 'spread': '96.1', 'groupId': 'BG001'}, {'value': '226.5', 'spread': '62.6', 'groupId': 'BG002'}, {'value': '232.0', 'spread': '85.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Melanin index is optical skin parameter related to the melanin content in the tissue. Results are on a broad scale from 0 to 999 over 1 second to detect even the tiniest melanin/redness changes. This measurement is not intended to represent a more favorable tissue condition over other participants in the cohort. The higher the index number, the more pigment is present in the tissue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Erythema Index', 'classes': [{'categories': [{'measurements': [{'value': '275.8', 'spread': '94.5', 'groupId': 'BG000'}, {'value': '316.8', 'spread': '81.4', 'groupId': 'BG001'}, {'value': '284.7', 'spread': '56.0', 'groupId': 'BG002'}, {'value': '292.4', 'spread': '79.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Erythema Index is optical skin parameter related to the redness content in the tissue. Results are on a broad scale from 0 to 999 over 1 second to detect even the tiniest redness changes. This measurement is not intended to represent a more favorable tissue condition over other participants in the cohort. The higher the index number, the more pigment is present in the tissue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Temperature', 'classes': [{'title': 'Hot', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Warm-Normal', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': 'Cool', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Cold', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Skin Moisture', 'classes': [{'title': 'Excessively Dry', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Dry', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Skin Texture', 'classes': [{'title': 'Smooth', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Rough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Soft', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Firm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Other observations: (Pallor, Jaundiced, Mottled, Cyanotic, etc.)', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This measurement was documented as open text for the study team to add any additional skin conditions that were outside of the already described parameters.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-12', 'size': 1500194, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-26T15:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The qualified electrocardiogram reviewer will be blinded to the age of electrodes'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2022-11-10', 'resultsFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-22', 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of Algorithm Software Update', 'timeFrame': 'day 1', 'description': 'Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.'}, {'measure': 'Diagnostic Quality', 'timeFrame': 'day 1', 'description': 'Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'day 1', 'description': 'Participants with frequency and severity of unexpected adverse events'}, {'measure': 'Unanticipated Adverse Device Effects (UADE)', 'timeFrame': 'day 1', 'description': 'Participants with unanticipated adverse device effects (UADE).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Monitor'], 'conditions': ['Sudden Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.', 'detailedDescription': 'The purpose of this study is to validate the Philips DXL electrocardiogram Algorithm works as intended in the HeartStart Intrepid Monitor/Defibrillator after a software update was completed to address instances of high impedance. This study will also determine the diagnostic quality of the 12-lead electrocardiogram tracing from the HeartStart Intrepid Monitor/Defibrillator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '29 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to read, write, speak, and understand English\n* Age: 29 days to 89 years\n* Willing and able to provide informed consent and complete study procedures\n* Willing to have Philips representatives present during study procedures.\n\nExclusion Criteria:\n\n* Known allergy to medical adhesives, silicone, or latex (per self-report)\n* Any limitation or medical condition, including but not limited to physical or cognitive disability, that would affect the participant's ability to complete study activities (per investigator)\n* At the time of enrollment, current enrollment in any other interventional research study\n* An employee, or residing family member of an employee, of a company that designs, sells, or manufactures monitor/defibrillator technology or related products (including Philips)"}, 'identificationModule': {'nctId': 'NCT05636332', 'briefTitle': 'The Intrepid Clinical Engineering Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study', 'orgStudyIdInfo': {'id': 'CCTCECRIntrepid 12Lead2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'New electrodes', 'description': 'New package of electrodes', 'interventionNames': ['Diagnostic Test: 12 lead Electrocardiogram']}, {'type': 'OTHER', 'label': '24-hour opened electrodes', 'description': 'Electrodes opened 24 hours', 'interventionNames': ['Diagnostic Test: 12 lead Electrocardiogram']}, {'type': 'OTHER', 'label': '30 day opened electrodes', 'description': 'Electrodes opened 30 days', 'interventionNames': ['Diagnostic Test: 12 lead Electrocardiogram']}], 'interventions': [{'name': '12 lead Electrocardiogram', 'type': 'DIAGNOSTIC_TEST', 'description': '12 lead Electrocardiogram', 'armGroupLabels': ['24-hour opened electrodes', '30 day opened electrodes', 'New electrodes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33971', 'city': 'Lehigh Acres', 'state': 'Florida', 'country': 'United States', 'facility': 'Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)', 'geoPoint': {'lat': 26.62535, 'lon': -81.6248}}], 'overallOfficials': [{'name': 'Alaa El-Gendy, MD, MSc, FCCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}