Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT03610269
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2018-07-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalresearchdept@masimo.com', 'phone': '949-297-7416', 'title': 'Vikram Ramakanth', 'organization': 'Masimo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During the duration of the study and 2 weeks after participation in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'INVSENSOR00026', 'description': 'All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 2, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vasovagal syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVSENSOR00026', 'description': 'All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours per subject', 'description': 'Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.', 'unitOfMeasure': 'g/dL', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'INVSENSOR00026', 'description': 'All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unable to draw blood', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Screen fail', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'INVSENSOR00026', 'description': 'All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '106', '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': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Number of baseline participants excludes data from subjects with protocol deviations or those with insufficient blood sample volume.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-18', 'size': 14326292, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-18T15:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2018-07-26', 'resultsFirstSubmitDate': '2019-04-19', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-05', 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation', 'timeFrame': 'Up to 2 hours per subject', 'description': 'Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': "The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Subject has given written informed consent to participate in the study\n\nExclusion Criteria:\n\n* (\\*) Pregnant or positive human chorionic gonadotropin (hCG) test\n* (\\*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis\n* (\\*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)\n* (\\*) Subjects who are currently taking anticoagulant medication\n* (\\*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic\n* (\\*) Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.\n* (\\*) Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.\n* (\\*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.\n* (\\*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw\n* Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff\n\nNote: (\\*) May be self-reported by subject'}, 'identificationModule': {'nctId': 'NCT03610269', 'briefTitle': 'Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026', 'orgStudyIdInfo': {'id': 'TORR0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INVSENSOR00026', 'description': 'All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).', 'interventionNames': ['Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor)']}], 'interventions': [{'name': 'INVSENSOR00026 (Pulse CO-Oximeter and sensor)', 'type': 'DEVICE', 'description': 'Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)', 'armGroupLabels': ['INVSENSOR00026']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}