Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-02-23 @ 9:23 PM
Study NCT ID:
NCT03273166
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2017-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D006438', 'term': 'Hemodilution'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studies@masimo.com', 'phone': '(949) 297-7000', 'title': 'Chelsea Frank', 'organization': 'Masimo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 to 5 hours', 'description': 'Adverse Events were not collected with respect to the interventions, only on participants as a whole.', 'eventGroups': [{'id': 'EG000', 'title': 'INVSENSOR00001', 'description': 'All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 2, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irregular EKG readings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'INVSENSOR00001', 'description': 'All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.'}, {'id': 'OG001', 'title': 'Control SpHb Sensor', 'description': 'All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': 'Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.', 'unitOfMeasure': 'g/dL', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'INVSENSOR00001', 'description': 'All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Withdrawn prior to Completion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}]}]}], 'preAssignmentDetails': 'Fingers were not randomized to the two interventions. All participants received both interventions in the exact same manner.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'INVSENSOR00001', 'description': 'All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', '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': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity, Customized', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Asian or Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-08', 'size': 296267, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-11T19:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2018-09-18', 'completionDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2017-09-01', 'dispFirstSubmitQcDate': '2020-10-22', 'resultsFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2017-09-01', 'dispFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-22', 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation', 'timeFrame': '1-5 hours', 'description': 'Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference values obtained by a laboratory hematology analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced by administering intravenous fluids to the volunteer in a controlled manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Competent adults between the ages of 18 and 50 years of age\n* Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall\n* BMI ≤ 35 unless the physician determines that a higher BMI is not due to morbid obesity, to safeguard subject safety during hemodilution\n* Must have a hemoglobin value ≥ 11 g/dL at time of screening, to safeguard subject safety during hemodilution\n* Baseline heart rate between 45 bpm and 85 bpm\n* CO value less than 2.0% FCOHb\n* Physical status of ASA I or II (American Society of Anesthesiology Class I; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) The ASA definition strictly applies to the systemic disease portion of the classification\n* Systolic BP less than or equal to 140 mmHg and Diastolic BP less than or equal to 90 mmHg\n* Able to read and communicate in English\n\nExclusion Criteria:\n\n* Pregnancy or positive hCG test\n* Smokers (including e-cigarette users)\n* Subject has known drug or alcohol abuse. Subjects who uses recreational drugs\n* Subject has experienced a concussion or head injury with loss of consciousness within the last year\n* Any chronic bleeding disorders (i.e. hemophilia)\n* Any history of a stroke, myocardial infarction, or seizures\n* Any cancer or history of cancer (not including skin cancer)\n* Chronic neurological diseases (i.e. multiple sclerosis, Huntington's Disease)\n* Any cardiac dysrhythmias (i.e. atrial fibrillation)(without physicians clearance)\n* Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subject's level of consciousness\n* Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome\n* Subjects who have/are currently taking anticoagulant medication\n* Subjects who have taken opioid pain medication within 24 hours of start of study\n* Subjects who do not understand the study and the risks\n* Subjects having either signs or history of peripheral ischemia\n* Subjects who have had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, plastic surgery, major ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery\n* Subjects that have symptoms of congestion, head colds, flu, or other illnesses\n* Subjects with claustrophobia, or generalized anxiety disorder\n* Subjects who have been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months\n* Subjects with chronic unresolved asthma, lung disease and respiratory disease\n* Subjects with allergies to lidocaine, latex, adhesives, or plastic\n* Subjects with heart conditions, insulin-dependent diabetes or uncontrolled hypertension\n* Subjects who have given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization or had a c-section within the last 6 months\n* Subjects who intend on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw and/or arterial line placement\n* Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator)"}, 'identificationModule': {'nctId': 'NCT03273166', 'briefTitle': 'Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution', 'orgStudyIdInfo': {'id': 'TP-18788'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INVSENSOR00001 sensor', 'description': 'This is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.', 'interventionNames': ['Device: INVSENSOR00001', 'Device: Control SpHb sensor', 'Procedure: Hemodilution']}], 'interventions': [{'name': 'INVSENSOR00001', 'type': 'DEVICE', 'description': 'This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.', 'armGroupLabels': ['INVSENSOR00001 sensor']}, {'name': 'Control SpHb sensor', 'type': 'DEVICE', 'description': 'This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.', 'armGroupLabels': ['INVSENSOR00001 sensor']}, {'name': 'Hemodilution', 'type': 'PROCEDURE', 'description': 'This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.', 'armGroupLabels': ['INVSENSOR00001 sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Masimo Clinical Lab', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}