Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05896267
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2023-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalresearchdept@masimo.com', 'phone': '949-297-7000', 'title': 'Chelsea Frank', 'organization': 'Masimo Corporation'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 30 minutes', 'eventGroups': [{'id': 'EG000', 'title': 'Masimo INVSENSOR00061', 'description': 'Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.\n\nMasimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SpO2 Accuracy of INVSENSOR00061', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Masimo INVSENSOR00061', 'description': 'Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.\n\nMasimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) in blood .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 15 minutes', 'description': 'SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.', 'unitOfMeasure': 'percent of oxygen saturated hemoglobin', 'reportingStatus': 'POSTED', 'populationDescription': '30 subjects were excluded from the analysis and replaced with new participants because of incorrect sensor placement.'}, {'type': 'PRIMARY', 'title': 'Pulse Rate Accuracy of INVSENSOR00061', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Masimo INVSENSOR00061', 'description': 'Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.\n\nMasimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) in blood .'}], 'classes': [{'categories': [{'measurements': [{'value': '4.45', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 15 minutes', 'description': 'Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.', 'unitOfMeasure': 'beats per minute', 'reportingStatus': 'POSTED', 'populationDescription': '30 subjects were excluded from the analysis and replaced with new participants because of incorrect sensor placement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Masimo INVSENSOR00061', 'description': 'Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.\n\nMasimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Masimo INVSENSOR00061', 'description': 'Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.\n\nMasimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', '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': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-02', 'size': 3468921, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-05T15:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2023-05-31', 'resultsFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-02-20', 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO2 Accuracy of INVSENSOR00061', 'timeFrame': 'Approximately 15 minutes', 'description': 'SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.'}, {'measure': 'Pulse Rate Accuracy of INVSENSOR00061', 'timeFrame': 'Approximately 15 minutes', 'description': 'Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Spo2']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '37 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Subject is a full-term newborn (37 weeks) to 18 months of age.\n\nExclusion Criteria:\n\n* • Subject has underdeveloped skin.\n\n * Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.\n * Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.\n * Subject is not suitable for the investigation at the discretion of the Investigator.'}, 'identificationModule': {'nctId': 'NCT05896267', 'briefTitle': 'SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061', 'orgStudyIdInfo': {'id': 'BAIL0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Masimo INVSENSOR00061', 'description': 'Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.', 'interventionNames': ['Device: Masimo INVSENSOR00061']}], 'interventions': [{'name': 'Masimo INVSENSOR00061', 'type': 'DEVICE', 'description': 'Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )', 'armGroupLabels': ['Masimo INVSENSOR00061']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Bailony Pediatrics', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}