Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 't.j.battisti@philips.com', 'phone': '(425) 205-3515', 'title': 'T.J. Battisti', 'organization': 'Philips'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Clinically Acceptable Performance of Remote Control Functionality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '88.4', 'ciUpperLimit': '100', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Only descriptive statistics was provided. The rate and the exact 95% CI of the rate using the Clopper-Pearson Exact method is calculated.'}], 'paramType': 'NUMBER', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'The system responds to the remote input as intended and without a delay interfering with the conduct of the exam. Additionally, a clinically acceptable exam would result in no adverse events related to the control feature', 'unitOfMeasure': 'Percentage of total exams', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Technical Issues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'Number of subjects for which device deficiencies are reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Success Rates for Key Tasks in the Collaborative Exam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Travel Reduction Attributable to Use of Collaboration Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'spread': '18.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intra-procedural (1 day)', 'description': "Distance between the scanning facility and the investigator's location will be recorded (in miles).", 'unitOfMeasure': 'miles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'classes': [{'title': 'Physician assessment', 'categories': [{'title': 'Strongly Agree', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Sonographer Assessment', 'categories': [{'title': 'Strongly Agree', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intra-procedural (1 day)', 'description': '5-point (Likert) scale data will be reported by the investigator.( 5 = Strongly agree, 4 = Agree, 3 = Neutral, 2 = Disagree, 1 = Strongly disagree)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'User Feedback Regarding Streaming, Image Quality and Overall Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'classes': [{'title': 'Physician Assessment', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Sonorapher', 'categories': [{'title': 'Acceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intra-procedural (1 day)', 'description': '5-point (Likert) scale data will be reported by the investigator. ( 5 = Very good, 4 = Good, 3 = Acceptable, 2 = Poor, 1 = Very Poor)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Feedback Regarding Remote Consultation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'classes': [{'categories': [{'title': 'Good', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'Tele-medicine Satisfaction Questionnaire', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Impact of Remote Consultation on Reimbursement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.9', 'spread': '7.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Submitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation', 'unitOfMeasure': 'percentage of standard amount', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental - Collaboration Live Software', 'description': 'Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '30', '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': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '6.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-16', 'size': 734684, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-01T17:14', 'hasProtocol': False}, {'date': '2019-10-24', 'size': 639563, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-01T18:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2020-01-21', 'resultsFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2020-01-24', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-10', 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Clinically Acceptable Performance of Remote Control Functionality', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'The system responds to the remote input as intended and without a delay interfering with the conduct of the exam. Additionally, a clinically acceptable exam would result in no adverse events related to the control feature'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Technical Issues', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'Number of subjects for which device deficiencies are reported'}, {'measure': 'Success Rates for Key Tasks in the Collaborative Exam', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control'}, {'measure': 'Travel Reduction Attributable to Use of Collaboration Live', 'timeFrame': 'Intra-procedural (1 day)', 'description': "Distance between the scanning facility and the investigator's location will be recorded (in miles)."}, {'measure': 'Ease of Use', 'timeFrame': 'Intra-procedural (1 day)', 'description': '5-point (Likert) scale data will be reported by the investigator.( 5 = Strongly agree, 4 = Agree, 3 = Neutral, 2 = Disagree, 1 = Strongly disagree)'}, {'measure': 'User Feedback Regarding Streaming, Image Quality and Overall Experience', 'timeFrame': 'Intra-procedural (1 day)', 'description': '5-point (Likert) scale data will be reported by the investigator. ( 5 = Very good, 4 = Good, 3 = Acceptable, 2 = Poor, 1 = Very Poor)'}, {'measure': 'Patient Feedback Regarding Remote Consultation', 'timeFrame': '1 day', 'description': 'Tele-medicine Satisfaction Questionnaire'}, {'measure': 'Impact of Remote Consultation on Reimbursement', 'timeFrame': '30 days', 'description': 'Submitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Collaboration Live', 'Telemedicine', 'Ultrasound'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Collaboration Live is a prospective, single-arm clinical study of subjects who provide written consent. Subjects are scanned using a Philips EPIQ 5 or EPIQ 7 Ultrasound System equipped with Collaboration Live software. The study investigator will evaluate performance of the Collaboration Live tool with regard to performance of conferencing, sharing and control capabilities. Adverse events will be reported and the study investigator will assess potential relationship to the study device or study procedure. Additionally, the utility of Collaboration Live in remote consult of study patients will be evaluated. No patient follow-up beyond the initial consultation will be conducted with the Collaboration Live software solution.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Subject in indicated for a routine OB/GYN ultrasound examination at the site.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at least 18 years of age\n* Subject in indicated for a routine Obstetrics/Gynecology ultrasound examination at the site.\n* Subject is willing and capable of providing informed consent and participating in this study\n\nExclusion Criteria:\n\n* A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion'}, 'identificationModule': {'nctId': 'NCT04243369', 'briefTitle': 'Collaboration Live', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Collaboration Live Clinical Study', 'orgStudyIdInfo': {'id': 'US-GIS-10649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Experimental - Collaboration Live software', 'interventionNames': ['Device: Non-diagnostic software solution']}], 'interventions': [{'name': 'Non-diagnostic software solution', 'type': 'DEVICE', 'description': 'Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.', 'armGroupLabels': ['Experimental - Collaboration Live software']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Perinatal Associates of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87124', 'city': 'Rio Rancho', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Perinatal Associates of New Mexico', 'geoPoint': {'lat': 35.23338, 'lon': -106.66447}}, {'zip': '87505', 'city': 'Santa Fe', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Perinatal Associates of New Mexico', 'geoPoint': {'lat': 35.68698, 'lon': -105.9378}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}